Specimen testing and health support system

Abstract

To provide a system for a sample test and a health support to maintain or improve the health state of the inside of a mouth and a body.SOLUTION: There is provided a health support service which can maintain or improve the health state of a subject by analyzing the result of sample tests including such test items as an antibody test related to dental bacteria or candida and a blood test related to glucose metabolism and various different types of information of a subject.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] By combining oral-related information such as oral hygiene and health conditions, which are increasingly being revealed as potential factors contributing to diseases and disorders throughout the body, with specimen test information related to such diseases and disorders throughout the body, it is possible to provide useful information not only for the treatment of systemic diseases but also for post-treatment care, especially for maintaining and promoting overall health in the elderly and vulnerable populations. The present invention relates to a test that can provide such useful information and a system for supporting the health of a subject by utilizing such a test.

Background Art

[0002] In recent years, it has become increasingly clear that oral hygiene and health conditions may be contributing factors to diseases and disorders throughout the body, and such information is becoming important not only for the treatment of systemic diseases but also for post-treatment care, especially for maintaining and promoting overall health in the elderly and vulnerable populations. However, there are problems in that oral-related information is rarely obtained and, even when obtained, remains within the institution where it was obtained, such as a dental clinic, and is not utilized by other institutions. In particular, it is extremely rare for information to be shared among medical institutions in the medical field, and even in a general hospital with a dental department, medical and dental information is often not shared with each other.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Provided is a test that can grasp information regarding the oral condition, which is closely related to maintaining and improving a person's QOL, and information regarding the whole body that can be considered in relation to the oral condition. Further provided is a health support system that supports the prevention, treatment, and post-treatment care of diseases and disorders in a subject's whole body and the maintenance and promotion of health, based on knowledge of the relationship between oral function, oral hygiene, and overall health.

Means for Solving the Problems

[0004] In view of the above circumstances, the inventors have conducted thorough studies and aim to provide a test that combines information such as the state of microorganisms present in the oral cavity that can affect the entire body, the state of oral hygiene, and the presence or absence of infection with specimen test items such as blood glucose levels that are considered to be related to the oral cavity. Furthermore, by utilizing the above test, the inventors aim to provide a health support system that enables subjects to maintain and improve their health, and to receive effective disease prevention and medical treatment, compared to the case of general blood tests alone. [Effects of the Invention]

[0005] This invention enables the realization and maintenance of a high quality of life (QOL) for subjects by constructing a health support system that allows for the assessment of the oral and pharyngeal condition of subjects, as well as their overall health status, without imposing a significant burden of effort or cost on subjects or those conducting the tests. This system provides useful information for maintaining the subjects' health, improves the subjects' daily lives and hygiene, provides effective medical treatment and prognosis, and contributes to the maintenance and promotion of health in healthy individuals. [Brief explanation of the drawing]

[0006]

Figure 1

Figure 2

Figure 3

[0007] In other words, the present invention encompasses the following inventions. Item 1: Specimen testing including items i-iii below. i) Antibody tests related to one or more microorganisms selected from the group consisting of oral bacteria and Candida. ii) Testing of blood glucose and / or hemoglobin A1c levels iii) Testing for LDL and HDL levels Item 2: A specimen test as described in Item 1, in which the oral bacteria include one or more bacteria selected from at least one bacterium belonging to the genus Porphyromonas. Item 3: Oral bacteria at least Porphyromonas gingivalis The specimen tests described in item 2, which include the following: Item 4: Oral bacteria include at least two or three different species. Porphyromonas gingivalis The specimen test described in item 3, which includes the bacterial strain. Item 5: Oral bacteria at least Streptococcus mutans A specimen test as described in any one of items 1 to 4, which includes [the specified item]. Item 6: Oral bacteria at least Streptococcus intermedius A specimen test as described in any one of items 1 to 5, which includes [the specified item]. Item 7: A specimen test described in any one of items 1-6, wherein the oral bacteria include one or more bacteria selected from the genus Fusobacterium. Item 8: A specimen test described in any one of items 1-7, wherein the oral bacteria include one or more bacteria selected from at least one bacterium belonging to the genus Prevotella. Item 9: A specimen test that includes an antibody test related to oral bacteria and one or more tests selected from C-reactive protein testing, procalcitonin testing, and erythrocyte sedimentation rate testing. Item 10: A specimen test as described in Item 9, in which the oral bacteria include one or more species of bacteria belonging to the genus Staphylococcus and one or more species of bacteria belonging to the genus Streptococcus. Item 11: A specimen test as described in any one of items 1 to 10, which includes an antigen test and / or nucleic acid test related to one or more microorganisms selected from the group consisting of oral bacteria and Candida. Item 12: A specimen test according to any one of claims 1 to 11, wherein the test item includes providing information about the oral cavity of the subject. Item 13: A specimen test as described in Item 12, wherein the subject's oral information includes information contained in any of the following: recommendations for dental examinations, recommendations for dental health guidance, information on oral health status, information on risk factors for oral health, information on oral hygiene, and information on recommended oral care products. Item 14: A health support system that uses the results of antibody tests related to oral bacteria and / or Candida, and the information described in (i) or (ii) below, to create information useful for disease prevention and treatment, and for maintaining and promoting oral and overall health in subjects, and provides this information to subjects, medical institutions, healthcare professionals, etc. (i) Results of a specimen test including one or more test items selected from the group consisting of blood glucose level, hemoglobin A1c level, oxidized HDL level, C-reactive protein level, procalcitonin level, and erythrocyte sedimentation rate. (ii) Subject information including at least one or more of the following: recommended information for dental examinations, recommended information for dental health guidance, general attribute information such as the subject's own gender, age, height, weight, waist circumference, BMI, waist-to-hip ratio, and medical history information of blood relatives, subjective information about oral and overall health status, treatment history information, information about oral function and oral condition, oral hygiene habits, actual information about dietary habits, lifestyle habits, exercise habits, drinking habits, smoking habits, sleep behavior information, and psychological state information. Item 15: A health support system that uses three pieces of information—results of antibody tests related to oral bacteria and / or Candida, the information in (i) and (ii) below—to create information useful for disease prevention and treatment of subjects and for maintaining and promoting oral and overall health, and provides this information to subjects, medical institutions, healthcare professionals, etc. (i) Results of a specimen test including one or more test items selected from the group consisting of blood glucose level, hemoglobin A1c level, oxidized HDL level, C-reactive protein level, procalcitonin level, and erythrocyte sedimentation rate. (ii) Subject information including at least one or more of the following: recommended information for dental examinations, recommended information for dental health guidance, general attribute information such as the subject's own gender, age, height, weight, waist circumference, BMI, waist-to-hip ratio, and medical history information of blood relatives, subjective information about oral and overall health status, treatment history information, information about oral function and oral condition, oral hygiene habits, actual information about dietary habits, lifestyle habits, exercise habits, drinking habits, smoking habits, sleep behavior information, and psychological state information. Item 16: A health support system as described in Item 14 or 15, comprising oral bacteria, one or more selected from at least two bacteria belonging to the genus Porphyromonas. Item 17: Oral bacteria at least Porphyromonas gingivalis A health support system as described in item 16, which includes the health support system described in item 16. Item 18: Oral bacteria include at least two or three different species. Porphyromonas gingivalis A health support system as described in item 17, which includes the strain of bacteria. Item 19: Oral bacteria at least Streptococcus mutans A health support system as described in any one of paragraphs 14-18, which includes the above. Item 20: Oral bacteria at least Streptococcus intermedius A health support system as described in any one of paragraphs 14-18, which includes the above. Item 21: A health support system as described in any one of items 14-20, wherein the oral bacteria include one or more bacteria selected from at least one bacterium belonging to the genus Fusobacterium. Item 22: A health support system as described in any one of items 14-21, comprising oral bacteria, one or more selected from at least one bacterium belonging to the genus Prevotella. Item 23: A health support system described in any one of items 14-18, which stores some or all of the results of specimen tests and information useful for disease prevention, treatment, and maintenance and promotion of the subject's health, created from the results of specimen tests, in an electronic medical record or a database used for the subject's health management, and utilizes this information for disease prevention, treatment, and maintenance and promotion of the subject's health. Item 24: The health support system according to any one of Items 14 to 23, including an antigen test and / or a nucleic acid test related to one or more microorganisms selected from the group consisting of oral bacteria and Candida bacteria as test items.

[0008] The oral bacteria that are the subject of the test of the present invention mean bacteria existing in the oral cavity and throat, which are said to be 400 to 800 or more species. The types of bacteria constituting the oral resident flora vary from subject to subject, and it is known that they also vary depending on changes such as age, oral hygiene status, systemic diseases, and metabolism in a specific subject. Although the presence or absence of periodontal disease, dental caries, etc. is determined in dental check-ups and dental treatments, not only can they be estimated by a simple method according to the technology of the present invention, but also the oral infection risks such as the risk of developing or recurring oral infections and the likelihood of exacerbation during oral infections, and information on the presence and degree of a constitution in which it is difficult to obtain the effects of treatment methods and preventive measures against standard oral infections can be provided. Therefore, as the oral bacteria to be the subject of the sample test of the present invention, bacteria known to be able to affect oral health are preferable, and it is more preferable to target bacteria that may affect the development and progression of diseases. In addition to bacteria, Candida fungi ( Candida albicans ) are also known as causative bacteria of oral infections, so it is preferable to be the subject of the sample test. Examples of bacteria that can have an adverse effect on oral health include, for example, the so-called Red Complex related to periodontal disease Porphyromonas gingivalis (Porphyromonas gingivalis), Treponema denticola (Treponema denticola), Tannerella forsythia (Tannerella forsythia), in addition to these three types of bacteria, Aggregatibacter actinomycetemcomitans (Aggregatibacter actinomycetemcomitans: the former scientific name was Actinobacillus actinomycetemcomitans ), the so-called Orange Complex, Prevotella intermedia (Prevotella intermedia), Eubacterium nodatum (Eubacterium nodatum), Fusobacterium nucleatum (Fusobacterium nucleatum), Fusobacterium polymorphum (Fusobacterium polymorphum), Prevotella nigrescens(Prevotella nigrescens), Peptostreptococcus micros (Peptostreptococcus micros), Campylobactor rectus (Campylobacter rectus), Campylobacter showae , Campylobacter gracilis (Campylobacter gracilis), Streptococcus constellatus (Streptococcus constellatus), etc. Other bacteria that are known to have a direct or indirect relationship with dental caries, Streptococcus mutans (Streptococcus mutans), Streptococcus sobrinus (Streptococcus sobrinus), Actinomyces naeslundii (Actinomyces naeslundii), Actinomyces viscosus (Actinomyces viscosus), Actinomyces odontolyticus (Actinomyces odontolyticus), Actinomyces oris (Actinomyces oris), and others that are known to be related to dental plaque formation Corynebacterium matruchotii (Corynebacterium matruchotii), which is known to be associated with actinomycosis of the jaw Actinomyces israelli (Actinomyces israelii), which is known to be associated with invasive infections in the elderly Streptococcus agalactiae (Streptococcus agalactiae), etc.

[0009] "Related to one or more microorganisms selected from the group consisting of oral bacteria and Candida" means that the subject of the specimen test is nucleic acid, antigen, and antibody derived from one or more microorganisms selected from the group consisting of oral bacteria and Candida, or nucleic acid, antigen, and antibody showing reactivity equivalent to the derived gene, antigen, and antibody. Specifically, in the case of nucleic acid testing, it means that the nucleic acids corresponding to all oral bacteria and Candida to be tested are the subject of the test; in the case of antigen testing, it means that the antigens corresponding to all oral bacteria and Candida to be tested are the subject of the test; in the case of antibody testing, it means that the antibodies corresponding to all oral bacteria and Candida to be tested are the subject of the test, and substances showing reactivity equivalent to them are the subject of the test.

[0010] Antibodies tested in antibody tests refer to proteins that have the activity to specifically bind to antigens produced by antigen stimulation by the bacterial cell itself, a part of the bacterial cell, or compounds derived from the bacteria. Antigens that react with antibodies include not only the bacterial cell itself, a part of the bacterial cell, and compounds derived from the bacteria, but also antigen peptides and combinations thereof that have similar reactivity. When testing antibodies related to two or more bacteria, an antigen-antibody reaction is used, utilizing antigens with distinct antigenic structures corresponding to each antibody. In this case, it is desirable that there is virtually no cross-reactivity between each antigen-antibody reaction or with antibodies against other bacteria contained in the sample. Here, "virtually no cross-reactivity" means that even if some cross-reactivity occurs, it is considered not to be cross-reactivity as long as the presence of antibodies for each of the tested bacteria can be distinguished. Furthermore, while antibody tests can be qualitative tests that determine the presence or absence of antibodies, tests that can measure antibody titers are preferable because they provide information that can infer the degree and timing of infection.

[0011] It has been found that there is a close relationship between oral hygiene, periodontal disease, diabetes, and arteriosclerosis. There is also a relationship between oral hygiene and fluctuations in blood glucose levels, and it has been reported that managing oral hygiene can control blood glucose levels, which is very important in the management of the pathological condition of diabetes. However, there is little cooperation between the medical and dental fields, so medical information in both fields is not shared, not only among private practitioners but also among general hospitals with oral surgery departments, and medical practices remain independent of each other. Antibody tests for oral bacteria can obtain information on the presence or absence of antibodies produced when oral bacteria invade the body, as well as information on the microorganisms from which those antibodies originate, allowing for an understanding of the condition of the oral cavity and the degree of infection by oral microorganisms that have invaded the body. By performing this specimen test in conjunction with conventional blood glucose and other tests, it becomes possible to enhance the effectiveness of treatment for diseases such as diabetes and to effectively manage disease conditions such as blood glucose levels. This is because it allows for the combined provision of this information, enabling the treatment of oral diseases such as periodontal disease and the provision of dental health guidance to people with poor oral hygiene. Therefore, the specimen test of the present invention, which can provide this information in conjunction, is extremely effective.

[0012] The test samples used for blood glucose, hemoglobin A1c, LDL, and HDL level tests and antibody tests may be the same or different, but the samples must be collected at the same time. While sampling times that differ by a few days are still considered "same time," sampling on the same day is preferable. Different sampling times are undesirable because they may alter the subject's condition, making it difficult to accurately obtain subject information. Antibody test samples can be blood (including blood components), gingival crevicular fluid, dental plaque, tongue coating, or saliva obtained from the oral cavity, throat, or oral tissue, but it is preferable to use blood collected during health checkups or blood tests at medical institutions. When using different test samples for blood glucose, hemoglobin A1c, LDL, HDL, and antibody tests, the samples must be collected at the same time. While sampling times that differ by a few days are still considered "same time," sampling on the same day is preferable. Different sampling times may result in changes in the subjects' condition, creating a risk of difficulty in accurately obtaining information about the subjects, which is undesirable.

[0013] As mentioned above, it is becoming clear that bacteria associated with periodontal disease are linked to systemic diseases. In the medical field, it is becoming recognized that poor oral hygiene in patients can lead to complications such as infections after surgical procedures, and there are reports of cases where oral hygiene is improved or periodontal disease symptoms are treated as pre-surgical measures. Periodontal disease, in particular, is a disease in which bacteria in the mouth proliferate or invade periodontal tissues, causing inflammation and damaging periodontal tissues such as the gums and alveolar bone. Since there are many capillaries in periodontal tissue, oral bacteria can enter the bloodstream and potentially affect tissues throughout the body. Research has revealed deep connections with several systemic diseases to date, and understanding the state of biological infection by oral bacteria associated with periodontal disease is an important matter for managing overall health. In explaining the pathogenesis of periodontal disease, bacteria called the Red Complex play a central role. Porphyromonas gingivalis It plays the most important role. On the other hand, Porphyromonas bacteria present in the oral cavity have been linked to systemic diseases. For example, systemic diseases in which Porphyromonas bacteria are thought to be associated include arteriosclerosis, which has been linked to studies of bacteria detected in lesions and animal test results; rheumatoid arthritis, which has been linked to the production of an enzyme (peptidylarginine diminase) that generates anti-citrullinated proteins used as a marker, and observational information on the effect of periodontal disease treatment and changes in symptoms; diabetes mellitus; and non-alcoholic fatty liver disease. Porphyromonas gingivalis It is known that there is a particularly strong correlation, and not only does it have an impact that causes infectious diseases. Porphyromonas gingivalis Since gingipain and liposaccharide (LPS), which are produced by this organism, have been detected in the brain tissue of dementia patients, there are reports that they may be related to the onset and progression of dementia. Porphyromonas gingivalis It is becoming increasingly known that even within the same group, different strains can have vastly different effects on oral and systemic health. Therefore, the oral bacteria to be examined in this invention are at least Porphyromonas gingivalisIt is preferable that the test includes information on bacterial strains as well as species. In addition, there are reports that the ratio of bacteria belonging to the Red Complex to the total number of bacteria in the oral cavity has a significant correlation with the amount of adiponectin secreted, which works to improve insulin resistance, suggesting a possible link to diabetes. Furthermore, since the aforementioned ratio has been confirmed to correlate with the levels of inflammatory cytokines IL-1β and TNF-α in the blood, there are reports that it may be related to inflammatory diseases such as arteriosclerosis and diabetes. Furthermore, high levels in the serum of pregnant women who give birth to premature or low-birth-weight babies Porphyromonas gingivalis The IgG antibody titer was observed, and in the oral cavity of these pregnant women... Porphyromonas gingivalis , Tannerella forsythia , Aggregatibacter actinomycetemcomitans Because these bacteria are detected in significantly higher amounts, there are reports that oral bacteria may have some effect on the fetus or placenta. Although it is a rare disease, in arteriosclerosis obliterans and thromboangiitis obliterans (Buerger's disease), three types of bacteria of the Red Complex and Campylobactor rectus Related to the above has been reported. Therefore, Porphyromonas gingivalis (Porphyromonas gingivalis) also belongs to the Red Complex. Treponema denticola , Tannerella forsythia These are also important targets for specimen testing, and it is preferable to perform nucleic acid tests, antigen tests, and antibody tests on specimens collected from blood or the oral cavity, in an appropriate combination depending on the purpose. Therefore, it is preferable to test for these bacteria.

[0014] Along with periodontal disease, dental caries is a representative oral disease. The causative bacteria of dental caries include Streptococcus mutans Although this is widely known, like bacteria of the genus Porphyromonas, it has been suggested to be associated with systemic diseases. For example Streptococcus mutans Infectious endocarditis, valvular heart disease, cerebral hemorrhage, and aspiration pneumonia have been reported to be particularly associated with serotype κ. In particular, Cnm-positive bacteria express a special protein called Cnm on the surface of the bacterial cell. Streptococcus mutans It has been suggested that it is associated with cerebral microhemorrhages and dementia. Also, the same genus Streptococcus Streptococcus constellatusThere are reports that these bacteria are related to the formation of abscesses in the liver. Therefore, it is desirable to use these bacteria for testing purposes.

[0015] Streptococcus intermedius It is a bacterium that is deeply involved in the formation of dental plaque in the oral cavity. Numerous species of the Streptococcus genus have been identified as oral bacteria, Streptococcus intermedius These bacteria are known to form abscesses in the brain and liver. Furthermore, Streptococcus and Staphylococcus species, which are also commensal bacteria in the oral cavity, account for 80-90% of those detected in blood cultures of patients with infectious endocarditis. There have also been reports of genetic identification confirming the identity of these cultured bacteria with those in the oral cavity of the subjects. Staphylococcus epidermidis or Streptococcus milius These have been detected. Therefore, it is very useful to perform antibody tests for oral bacteria that include one or more species of Staphylococcus and one or more species of Streptococcus in addition to C-reactive protein tests, procalcitonin tests, and erythrocyte sedimentation rate tests. Streptococcus blood These bacteria have been reported to be associated with infectious heart disease. Therefore, it is preferable to include these bacteria in the test.

[0016] Fusobacterium are obligate anaerobic, non-spore-forming, Gram-negative rod-shaped bacteria that are normally present in the human oral cavity, pharynx, and intestinal tract, but their association with systemic diseases is also becoming increasingly recognized. Fusobacterium necrophorum and Fusobacterium nucleatum These bacteria have been reported to be associated with liver abscesses and aspiration pneumonia, and although these two types of bacteria are found in normal pregnant women, they have been detected in both the oral cavity and placenta of pregnant women, suggesting that they may have some effect on the fetus. There have also been reports of a link between these bacteria and gastrointestinal cancers such as esophageal cancer and colorectal cancer. Therefore, it is preferable to include these bacteria in the examination.

[0017] Prevotella species are primarily found in the intestines, but are also present as commensal bacteria in the oral cavity. In chronic respiratory diseases... Prevotella pallens In cases of premature birth or low birth weight babies Prevotella intermedii In Buerger's disease, Prevotella intermedia or Prevotella nigrescens There have been reports suggesting some kind of correlation. Therefore, it is preferable to include these bacteria in the tests.

[0018] In addition, the following individuals are included in the population: the elderly, those who experience dry mouth, those receiving steroid medication or chemotherapy, and denture wearers, and the test samples taken from the oral cavity. Candida albicans If Candida albicans is detected, it can be inferred that the person has or is likely to have oral candidiasis. In addition, nucleic acid tests, antigen tests, and antibody tests on test samples taken from periodontal tissue, Streptococcus constellatus (Streptococcus constellatus) and Prevotella intermedius If test results suggest a mixed infection with Prevotella intermedias, it is possible to infer the presence of an obstructive abscess in the oral cavity. Therefore, it is preferable to test for these microorganisms.

[0019] C-reactive protein testing, procalcitonin testing, and erythrocyte sedimentation rate testing are all specimen tests that provide information that can be used to infer the possibility of an inflammatory response occurring in some part of the body or the degree of inflammation. Antibody tests for oral bacteria and other factors can help to understand the possibility of inflammatory diseases in the oral region, and if the results suggest a strong inflammatory response, it can also help to understand the possibility of inflammatory diseases occurring in parts of the body other than the oral region in which oral bacteria are involved in some way. Therefore, by performing antibody tests related to oral microorganisms in addition to tests such as blood glucose levels, these tests can provide important information for analyzing test results and estimating the physical condition of the subject.

[0020] Antigens tested in antigen tests refer to bacterial cells themselves, parts of bacterial cells, and compounds derived from bacteria that possess an antigenic structure. When testing antigens associated with two or more bacteria simultaneously, antigen tests using separate antibodies corresponding to each bacterium are combined. In this case, it is desirable that the antibodies used in each antigen test show no substantial cross-reactivity with other bacteria present in the sample. Here, "no substantial cross-reactivity" means that even if some cross-reactivity occurs, it is considered as not showing cross-reactivity as long as the presence of the antigen of each bacterium being tested can be distinguished.

[0021] The methods that can be used for nucleic acid testing are not particularly limited as long as they utilize nucleic acids, and the most suitable method can be adopted depending on the purpose of the test. Examples include testing methods that utilize Conventional PCR, Real-time PCR, Reverse transcription PCR, Nested PCR, Hot start PCR, Multiplex PCR, Quantitative PCR, Quantitative Real-time PCR, Touchdown PCR, Inverse PCR, GC-rich PCR, 2-step PCR, loop-mediated isothermal amplification, digital PCR, Multiple Displacement Amplification such as Whole Genome Amplification, Strand displacement amplification, Nicking Enzyme Amplification Reaction, Helicase-dependent amplification, Recombinase Polymerase Amplification, Strand-Invasion Based Amplification, Nucleic Acid Sequences Based Amplification, and Transcription Mediated Amplification.

[0022] Nucleic acid testing and antigen testing should be appropriately selected and performed depending on the purpose of the test, either one or both. Both nucleic acid testing and antigen testing can determine the presence of oral bacteria, Candida, or fragments thereof in the test sample at the time of testing. The former detects the presence of nucleic acids, while the latter detects the presence of antigens, so the results of the two tests cannot be said to be completely identical. Therefore, it is necessary to analyze the test results while taking into account the principle of the test being performed and the specific test conditions. Nucleic acid testing and antigen testing also differ in detection accuracy and the time required for testing. In nucleic acid testing, methods utilizing EMA (Ethidium bromide monoazide) or PMA (Propidium monoazide) can determine the possibility of the presence of viable bacteria. Therefore, when conducting tests, the most suitable method, either alone or in combination, should be adopted after comprehensively considering the purpose of the test, the cost of the test, and the testing environment.

[0023] Nucleic acid and antigen test results include the species and number of bacteria detected, their proportion to the total number of bacteria (ratio to total bacterial count), and the types detected in specific strains. These can be appropriately selected as test results, taking into account the purpose of the test. Antibody test results include the presence or absence of antibodies derived from specific bacterial species or strains, and their antibody titers (neutralizing antibody titer, agglutinating antibody titer, etc.). These can be appropriately selected as test results, taking into account the purpose of the test. Furthermore, by comprehensively examining the above test results (combinations of bacterial species and their proportions, detected test items and test samples, etc.), it is possible to make inferences about oral health status and incorporate them into the above test results. Examples of patent publications describing technologies related to these include, but are not limited to, Japanese Patent Publication No. 2009-52945 (Method for examination or diagnosis of periodontal disease by immunochromatography), Japanese Patent Publication No. 2022-96817, Japanese Patent Publication No. 2022-96815, Japanese Patent Publication No. 2022-96814, Japanese Patent Publication No. 2022-96812, and Japanese Patent Publication No. 2017-111095 (all of which describe technical information related to the measurement of antibody titers against periodontal pathogens).

[0024] Including information about the subject's oral cavity in the examination items is useful because it allows subjects to recognize the condition of their own oral cavity, leading to improved awareness of oral hygiene, the implementation of specific oral hygiene practices, and the provision of necessary dental care and dental health guidance. Information about the subject's oral cavity may include, for example, information on periodontal disease, caries, plaque, the condition of tongue coating which can cause bad breath, glossitis, and taste disorders, recommendations for dental examinations if oral disease is suspected, recommendations for dental health guidance if oral hygiene is presumed to be poor, other information on oral health status, information on risk factors in the oral cavity and other parts of the body related to oral health, information on the importance of oral hygiene and specific oral hygiene methods, and information on oral care products and services that can be recommended to the subject.

[0025] This invention also provides a health support system that provides subjects, medical institutions, and healthcare professionals with information useful for disease prevention, treatment, and maintenance and promotion of the subjects' health. As a result, subjects can raise their awareness of oral care, acquire knowledge and skills related to oral care, and improve their daily oral care behaviors, thereby maintaining and improving their oral and overall health. Medical institutions can not only avoid and reduce risks in medical procedures performed on subjects, but also improve the efficiency and effectiveness of treatments and other measures.

[0026] The health support system of the present invention requires antibody test results related to one or more microorganisms selected from the group consisting of oral bacteria and Candida, and analyzes and examines them together with information belonging to either (i) or (ii) below, preferably both, to create "information useful for disease prevention and treatment of subjects and for maintaining and promoting oral and overall health," which is then provided to subjects, medical institutions, healthcare professionals, etc. Here, (i) refers to "results of specimen tests including one or more test items selected from the group consisting of blood glucose level, hemoglobin A1c level, oxidized HDL level, C-reactive protein level, procalcitonin level, and erythrocyte sedimentation rate," and (ii) refers to "one or more pieces of information included in at least one of the following: recommendations for dental examinations, recommendations for dental health guidance, general attribute information such as the subject's own sex, age, height, weight, waist circumference, BMI, waist-to-hip ratio, and medical history information of blood relatives, subjective information on oral and overall health status, treatment history information, oral hygiene habits, actual information on diet, lifestyle, exercise, drinking habits, and smoking habits, sleep behavior information, and psychological state information." The former are indicators closely related to diabetes, arteriosclerosis, and inflammatory diseases, while the latter are information that the subject can grasp themselves, such as genetic information closely related to lifestyle diseases and information useful for understanding and inferring the state of the oral cavity in relation to daily lifestyle habits.

[0027] The subject information described in (ii) above can be obtained from the subject's self-reporting, monitoring using terminal devices, electronic medical records, etc. As a method of self-reporting, for example, subject information from specific health checkups can be utilized. Specific health checkups gather subject information regarding medical history and subjective symptoms. Some of the medical history information and subjective symptoms in specific health checkups are obtained in the form of questions to the subject, such as a medical questionnaire. For example, in addition to medical history, items such as smoking habits, exercise habits, eating habits, drinking habits, and sleeping habits are common and can be utilized. Specific examples of subject information include general attribute information such as the subject's own gender, age, height, weight, waist circumference, BMI, waist-to-hip ratio, and medical history information of blood relatives, subjective information on oral and overall health, treatment history information, information on oral function, oral hygiene habits, eating habits and food preferences, actual information on lifestyle (life cycle), exercise habits, drinking habits, and smoking habits, information on bedtime behavior, and psychological state information. In addition to these, if necessary, we will also provide recommended information on dental examinations and dental health guidance as useful information.

[0028] In this invention, "maintaining and promoting oral and overall health" also includes "maintaining and improving healthy oral function." It is said that there is a relationship between oral function and overall systemic function. When oral function declines, motor abilities such as grip strength and walking ability decrease, a decline in masticatory function is associated with the progression of dementia symptoms, and a significant decline in masticatory and swallowing ability can lead to malnutrition and negatively affect overall health. Therefore, maintaining and improving oral function is an indispensable element for maintaining and improving overall health. Accordingly, "information necessary to maintain and improve the oral health of the subject" includes "information necessary to maintain and improve the oral function of the subject." Oral function is related to predation (taking food into the mouth), chewing, bolus formation and transport, swallowing, articulation, taste, touch, and saliva secretion, and is a basic function necessary for a person to lead a healthy life in society. For the reasons mentioned above, it is very useful to grasp information about these conditions.

[0029] Information necessary to maintain and improve oral function in a healthy state can be obtained, for example, by measuring the state of oral function using sensors, taking images or videos of the inside of the mouth and oral-related actions such as chewing, and recording sounds such as sounds of movement. Furthermore, the information necessary to maintain and improve oral function in a healthy state includes not only the information obtained as described above, but also secondary information obtained by analyzing and evaluating that information. The target "state of oral function" includes, for example, chewing, swallowing, other chewing-related functions (occlusion, occlusal force, tongue movement function during chewing, functional evaluation when wearing dentures), saliva secretion, mouth opening, and actions when taking food into the mouth (especially the movement of the mandible).

[0030] The "information useful for disease prevention and treatment, and maintenance and promotion of oral and overall health" provided to subjects, medical institutions, healthcare professionals, and employers of subjects includes: information useful for the treatment and prognosis management of subjects' diseases, information for raising awareness about the relationship between disease prevention, maintenance and promotion of overall health, and oral health; information useful for understanding, maintaining, and improving oral function; information on the treatment and prevention of recurrence of oral-related diseases necessary to maintain and improve oral function; information on problems that arise when using inappropriate toothpastes, toothbrushes, and other products, as well as criteria and methods for selecting appropriate products, and information on various oral care products (raw material information, incorrect use). This includes information on oral care such as problems that may arise during use and how to use them correctly, specific optimal oral care methods for a set period (for example, one week), oral problems that occur due to differences in age and gender, or in pregnant women, infants, and those requiring care, as well as methods for prevention and treatment, introductions to the latest oral care research, basic knowledge about dentures and implants, common problems with dentures and methods for prevention; information on oral care services and offers for providing oral care products and services; and information on bulletin boards and communities that serve as places for exchanging information and exercising to maintain and improve oral and overall health.

[0031] As shown in Figure 1, the health support system according to this embodiment connects a support server 1, a terminal 2 for inputting test results, and a terminal 5 for outputting information to transmit test results, etc., to subjects and medical personnel via a network N such as the Internet, and various information is sent and received. The support server 1 is also connected to the network N for communication and transmission of various information. If necessary, it estimates the oral and overall health status of subjects and their relationships based on test results and necessary information. If necessary, it also estimates the oral and overall health status of subjects and their relationships based on test results and necessary information. Furthermore, a computing device 3 is connected via the network N such as the Internet to create and select appropriate information to be provided to individual subjects and medical personnel regarding the maintenance and improvement of oral health status and the maintenance, improvement, and treatment of overall health, outside of the support server. Additionally, an external server 4 is connected via the network N such as the Internet to obtain various information other than test results necessary for estimating the oral and overall health status of subjects, and various information not stored in the support server 1, which is necessary for selecting and creating useful information regarding the maintenance and improvement of oral and overall health status to be provided to subjects. External servers include databases utilizing the My Number system, electronic health insurance cards, and electronic medical records managed by medical institutions and data management organizations. It is possible to acquire and utilize information on subjects, etc., from these external servers, and to transfer information acquired or created by the health support system of the present invention to these external servers and utilize them within the system.

[0032] In the health support system according to the above embodiment, the support server 1 may be divided into two or more. In this case, the divided servers may be able to send and receive various information from each other by means of connection that does not use the Internet, such as a local network, or they may be connected via a network N such as the Internet to send and receive various information, or they may have both. When there are multiple support servers, each support server can be assigned to perform tasks such as recording and data processing (calculations), as well as data and system backups, in an optimal manner for operating the system. When there are multiple support servers, at least one of the support servers 1 must have the function of selecting test results and information useful for improving or maintaining oral and overall health, and sending the said useful information to a designated terminal. Since test results and subject attribute information are personal information, it is preferable to send and receive information about them as infrequently as possible from the standpoint of confidentiality. If the location of the information data input terminal 2 is geographically far from the support server 1, another support server 1 may be set up in the same location as the information data input terminal 2, and the two may be connected without using a network such as the Internet, and the acquired and entered information may be recorded in the support server 1. This significantly reduces the number of times personal information is sent and received over the internet, thereby mitigating the risk of leakage of confidential information such as personal information. Furthermore, if the useful information generation unit of the processing unit of support server 1 cannot process or complete the information due to reasons such as information processing capacity, an external computing device can be used.

[0033] As shown in Figure 2, the support server 1 is composed of one or more computers comprising a processing unit 10 equipped with a communication control unit 12 and storage means 11. Specifically, a conventional computer device can be used, centered around the processing unit 10, with storage means 11, communication control unit 12, and input operation means (not shown) such as a pointing device, keyboard, or display.

[0034] The processing unit 10 is mainly composed of a CPU such as a microprocessor and has a storage unit consisting of RAM and ROM (not shown) where programs and processing data that define the procedures for various processing operations are stored. The storage means 11 can be selected from memory inside or outside the support server 1, hard disk drives (HDD), solid state drives (SSD), removable disk exchange systems (RDX), redundant arrays of inexpensive disks (RAID), etc. The contents of part or all of the storage unit may be stored in the memory or hard disk of another computer connected to the support server 1.

[0035] Functionally, the processing unit 10 is broadly divided into two functions: an "information collection and recording function" that acquires information necessary for the operation of the system and stores it in the storage means of a designated support server, and an "information generation and transmission function" that acquires information necessary for generating information such as test result information to be provided to each subject and information useful for improving or maintaining the subject's oral and overall health from the recording means, and transmits the information to the terminal 5 that creates and outputs the useful information. Specifically, each piece of information to be recorded is sequentially input from the terminal 2 as soon as the information to be input is obtained and recorded in the recording means. In this case, for example, if there are multiple support servers, it is possible to specify the recording means for recording information for each information item to be input, or to specify the recording means for recording information on a subject-by-subject basis. It is desirable to adopt the most optimal method from the standpoint of convenience of the "information generation and transmission function" that utilizes the recorded information and the prevention of information leakage. When providing information to a subject, the system generates the test results to be provided and, if necessary, information useful for improving or maintaining the subject's oral and overall health, and transmits this information together to the terminal 5. Terminal 5 can not only display and print information on screens, but also transfer information via terminal 5 to computers, smartphones, and recording media owned by subjects, medical institutions, and healthcare professionals. In this case, terminal 5 of the support system is a computer owned by a subject, and information can also be sent directly from support server 1 to terminal 5, i.e., a computer owned by a subject.

[0036] If there is only one support server 1, the storage means 11 includes at least a subject attribute information storage unit that stores subject attribute information acquired by the subject general attribute information acquisition unit, an examination information storage unit that stores examination result information acquired by the examination result information acquisition unit, a subject information storage unit that stores subject information acquired by the subject information acquisition unit, and a useful information storage unit that stores information useful for improving or maintaining the oral health of the subject, generated by the useful information generation unit. On the other hand, if there are multiple support servers 1, the subject attribute information storage unit, examination information storage unit, subject information storage unit, and useful information storage unit must be present in at least one of the support servers 1. However, for example, multiple support servers 1 may each have all of the storage units, and each storage unit may be present in multiple support servers 1. These can be freely designed in accordance with the actual operation of the system.

[0037] For subject information, particularly regarding behavioral actions, habits, and dietary content—areas where objectivity and accuracy are often lacking through questionnaires—it is desirable to acquire information using image or video data and devices utilizing various sensors. While dedicated measurement devices (terminals) are preferable, they can be substituted by connecting necessary accessories to a device such as a smartphone owned by the subject, or by installing a measurement application. The information acquired by these devices is ultimately stored in the support server 1 as either primary information or processed secondary information. As for the method of transmitting information from the terminal to the system, if the terminal has a communication unit that can connect directly to a network, such as a smartphone, the information is transmitted to the support server 1 via a network such as the internet. If the terminal does not have such a communication unit, the information acquired using short-range wireless communication (ANT+, Bluetooth®, ZigBee, IrDA, etc.) from the wireless or wired communication unit of the terminal is transferred to a computer or smartphone, and then transmitted to the support server 1 via a network such as the internet for storage. The following are specific examples of information retrieval, but are not limited to these examples.

[0038] Methods for acquiring information on the function and state of chewing and swallowing include: acquiring video information of the subject's actual chewing movements and analyzing the acquired video information to understand the details of chewing movements; acquiring video information of the throat movement when swallowing saliva, etc., and analyzing the acquired video information to understand the details of throat movement during swallowing; analyzing information acquired using electromyography sensors or photoelectric sensors to understand swallowing function; and analyzing audio information acquired in "oral diadochokinesis," in which specific sounds "pa," "ta," and "ka" are repeatedly pronounced within a certain time, to evaluate the speed and dexterity of movements of the tongue, lips, soft palate, etc., and understand oral function. Methods for determining occlusal function include: capturing pressure changes and maximum occlusal force during biting by biting on a piezoelectric sensor; attaching electromyography sensors to the jaw and temples during chewing and analyzing the resulting electromyographic information to trace occlusal function; acquiring the state of occlusion as image information and performing occlusal evaluation through AI analysis; using images and videos of chewing, phase difference information from distance sensors, and electromyographic and acceleration information from masticatory muscles to determine jaw movement and chewing frequency; analyzing stress information when a probe equipped with a piezoelectric sensor or pressure sensor is held between the tongue and jaw to determine tongue pressure capacity; and measuring blood flow in the tongue by pressing a probe equipped with an SpO2 photoelectric sensor against the tongue.

[0039] Information regarding oral functions and conditions other than chewing and swallowing can be obtained using the following methods. For example, using a sensor device equipped with a probe that has a pH sensor, the user can obtain the pH and buffering capacity of saliva (ability to maintain pH within the normal range), saliva secretion volume, dryness of the oral cavity and pharynx, serum antibody titers of oral bacteria, various analyses of saliva (calcium ion concentration, type and content of immunoglobulins, amount of reactive oxygen species, ammonia quantification, heparanase quantification, DNA / RNA analysis, estrogen quantification, leukocyte quantification, type and quantification of oxidative stress markers), oral viscosity, and using a sensor device equipped with a gas / breath sensor nozzle, the user can obtain the type and concentration of main gases indicating bad breath by blowing breath into the nozzle, the size of interdental spaces (opening area), tooth surface color, and number of remaining teeth indicating the condition of the teeth, the color and blood flow rate of the gums, the presence or absence of occult blood (for example, tests that apply the catalytic action of hemoglobin or immune responses), and the state of the user's oral flora by blowing breath into the nozzle.

[0040] Information regarding oral hygiene habits includes, for example, the type of toothbrush and toothpaste used, the frequency and duration of brushing, brushing methods and skill levels, information about brushing behavior, whether or not interdental cleaning tools are used and how often, the type of interdental cleaning tools used, whether or not mouthwash is used, the type and frequency of mouthwash use, and whether or not other oral cleaning tools (single-tuft brushes, Waterpiks, etc.) are used. This information can be obtained not only through questionnaires from subjects but also using devices equipped with various sensors. For example, this could involve attaching a device with a gyroscope or accelerometer to the toothbrush to understand the details of toothbrushing movements, using video information of oral hygiene behaviors such as toothbrushing, or using interactive lifestyle support systems such as wearable devices or smart vanity units.

[0041] In addition to information declared by the subject, treatment history information can be obtained from external servers 4 used by medical institutions, health insurance and labor unions, and organizations that manage electronic medical record systems. Examples of information that can be obtained include past health checkup and dental checkup history, treatment information for systemic and dental diseases, history of fluoride application, scaling and root planing, information on the presence or absence of implants and the procedure history, and information on consultation history for dietary guidance, health guidance and dental health guidance.

[0042] Information about dietary habits includes, for example, the number of meals eaten, the start time and duration of meals, the content of meals, whether or not assistance is provided during eating, whether or not snacks are eaten, and the type and amount of snacks consumed. It is preferable that this information be automatically acquired without the subject having to report it, using a dedicated device or similar method. For example, for information on the content of meals, which is difficult to provide, it is preferable to use a method in which AI analyzes and converts photographs of meals that are taken and transmitted into information about the content of the meals. It is also preferable to acquire as much information as possible about the subject's eating and drinking habits, such as the number of times they eat out, the content of meals eaten out, whether or not snacks are eaten and what they are, and the content and timing of beverage consumption. Furthermore, recently developed methods such as attaching taste sensors to spoons and chopsticks to directly measure salt concentration, sugar concentration, etc., during eating, and attaching mass sensors to tableware trays to determine the actual amount consumed by measuring before and after eating are also desirable examples.

[0043] Although embodiments of the present invention have been described above, the present invention is not limited in any way to these embodiments, and can be implemented in various forms without departing from the spirit of the invention. [Explanation of Symbols]

[0044] 1. Support Server 2 terminals 3. External computing device 4. Servers outside the system 5 devices 10 Processing Unit 11 Memory means 12 Communication Control Unit

Claims

1. A specimen test that includes the following items i, ii, and / or iii as test items, to provide useful information for maintaining and promoting overall health. i) Nucleic acid testing related to one or more microorganisms selected from the group consisting of bacteria and Candida present in the oral cavity and pharynx. ii) Testing for blood glucose and / or hemoglobin A1c levels iii) Testing for LDL and / or HDL levels

2. A specimen test according to claim 1, wherein the bacteria present in the oral cavity and throat include at least one or more bacteria selected from the group consisting of Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, Aggregatibacter actinomycetemcomitans, Fusobacterium nucleatum, Streptococcus mutans, Streptococcus sobrinus, Actinomyces naeslundii, Actinomyces viscosus, Actinomyces odontolyticus, Actinomyces oris, Streptococcus mitis, Prevotella nigrescens, Aggregatibacter actinomycetemcomitans, Corynebacterium matruchotii, and Streptococcus constellatus.

3. A specimen test according to claim 1, wherein the bacteria present in the oral cavity and throat include one or more bacteria selected from at least two bacteria belonging to the genus Porphyromonas.

4. A specimen test according to claim 1, wherein the bacteria present in the oral cavity and throat include one or more bacteria selected from at least one bacterium belonging to the genus Fusobacterium.

5. A specimen test according to claim 1, wherein the bacteria present in the oral cavity and throat include one or more bacteria selected from at least one bacterium belonging to the genus Prevotella.

6. The specimen test according to claim 1, wherein the bacteria present in the oral cavity and throat include at least Streptococcus mutans.

7. The specimen test according to claim 1, wherein the bacteria present in the oral cavity and pharynx include at least Streptococcus intermedius.

8. A specimen test according to claim 1, wherein, in addition to the results of the specimen test, information regarding the subject's oral cavity is provided.

9. The specimen test according to claim 8, wherein the information relating to the subject's oral cavity includes at least one of the following: recommended dental treatment information, recommended dental health guidance information, information relating to the oral health status, information relating to risk factors for oral health, information relating to oral hygiene, and information relating to recommended oral care products.

10. The specimen test according to claim 8, wherein the information regarding the subject's oral cavity includes recommended information for dental health guidance.

11. A health support system that uses nucleic acid test results related to bacteria and / or Candida present in the oral cavity and throat, along with the information described in (i) or (ii) below, to create information useful for disease prevention and treatment, and for maintaining and promoting oral and overall health in subjects, and provides the nucleic acid test results and the created useful information to subjects, medical institutions, and healthcare professionals. (i) Results of a specimen test including one or more test items selected from the group consisting of blood glucose level, hemoglobin A1c level, oxidized HDL level, C-reactive protein level, procalcitonin level, and erythrocyte sedimentation rate. (ii) Subject information including at least one or more of the following: recommended information for dental examinations, recommended information for dental health guidance, the subject's own sex, age, height, weight, waist circumference, BMI, waist-to-hip ratio, medical history information of blood relatives, self-awareness information about oral and overall health status, treatment history information, information about oral function and oral condition, oral hygiene habits, dietary habits, lifestyle habits, exercise habits, drinking habits, smoking habits, bedtime behavior information, and psychological state information.

12. A health support system that uses nucleic acid test results related to bacteria and / or Candida present in the oral cavity and throat, along with the information described in (i) and (ii) below, to create useful information related to disease prevention and treatment, and maintenance and promotion of oral and overall health in subjects, and provides the nucleic acid test results and the created useful information to subjects, medical institutions, and healthcare professionals. (i) Results of a specimen test including one or more test items selected from the group consisting of blood glucose level, hemoglobin A1c level, oxidized HDL level, C-reactive protein level, procalcitonin level, and erythrocyte sedimentation rate. (ii) Subject information including at least one or more of the following: recommended information for dental examinations, recommended information for dental health guidance, the subject's own sex, age, height, weight, waist circumference, BMI, waist-to-hip ratio, medical history information of blood relatives, self-awareness information about oral and overall health, treatment history information, information about oral function and oral condition, oral hygiene habits, dietary habits, lifestyle habits, exercise habits, drinking habits, smoking habits, bedtime behavior information, and psychological state information.

13. A health support system according to claim 11 or 12, wherein the bacteria present in the oral cavity and throat include at least one or more bacteria selected from the group consisting of Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, Aggregatibacter actinomycetemcomitans, Fusobacterium nucleatum, Streptococcus mutans, Streptococcus sobrinus, Actinomyces naeslundii, Actinomyces viscosus, Actinomyces odontolyticus, Actinomyces oris, Streptococcus mitis, Prevotella nigrescens, Aggregatibacter actinomycetemcomitans, Corynebacterium matruchotii, and Streptococcus constellatus.

14. A health support system according to claim 11 or 12, wherein the bacteria present in the oral cavity and throat include one or more bacteria selected from at least one bacterium belonging to the genus Porphyromonas.

15. A health support system according to claim 11 or 12, wherein the bacteria present in the oral cavity and throat include one or more bacteria selected from at least one bacterium belonging to the genus Fusobacterium.

16. A health support system according to claim 11 or 12, wherein the bacteria present in the oral cavity and throat include one or more bacteria selected from at least one bacterium belonging to the genus Prevotella.

17. A health support system according to claim 11 or 12, wherein the bacteria present in the oral cavity and throat include at least Streptococcus mutans.

18. A health support system according to claim 11 or 12, wherein the bacteria present in the oral cavity and throat include at least Streptococcus intermedius.

19. Furthermore, the health support system according to claim 11 or 12, which includes one or more evaluations from the group consisting of: understanding and evaluating oral function and oral condition using images or videos of the oral cavity; evaluating oral function using videos including the head during chewing and / or vocalization, and chewing sounds; and evaluating oral function using oral diadochokinesis.

20. Furthermore, the health support system according to claim 11 or 12, further comprising one or more pieces of information regarding the oral cavity and diet acquired using a sensor device as an examination item.

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