Bifidobacterium longum subsp. Infantis and application of microecological preparation thereof in preparation of product for preventing and treating irritable bowel syndrome

Abstract

The invention belongs to the technical field of biological medicines, and particularly relates to bifidobacterium longum subsp.infantis and application of a microecological preparation of the bifidobacterium longum subsp.infantis in preparation of products for preventing and treating irritable bowel syndrome. The bifidobacterium longum subsp. Infantis disclosed by the invention is bifidobacterium longum subsp. Infantis B8762, and the preservation number is CGMCC (China General Microbiological Culture Collection Center) No.22765. The strain and the microecological preparation thereof can be used for improving the severity score of an IBS-SSS disease of a patient, improving the IBS-QOL life quality of the patient, reducing the score of a psychological assessment somatic symptom group scale PHQ-15 and reducing the score of a non-gastrointestinal somatic symptom scale PHQ-12, so that the disease severity of the patient is improved, and the life quality is improved; the strain and the microecological preparation thereof can be used for preparing products for preventing, relieving and / or treating irritable bowel syndrome.

Description

Technical Field

[0001] The present invention belongs to the technical field of biomedicine, and particularly relates to the application of Bifidobacterium longum subsp. infantis and its microecological preparation in the preparation of products for preventing and treating irritable bowel syndrome. Background Art

[0002] Irritable Bowel Syndrome (IBS) is a common functional bowel disease, and its main characteristics include abdominal pain, abdominal distension, changes in bowel habits (such as diarrhea, constipation, or alternation of both), and abnormal stool characteristics, etc. And these symptoms often occur continuously or intermittently, seriously affecting the quality of life of patients. Although the exact cause of IBS has not been fully clarified, more and more studies have found that the bidirectional signal transmission between the brain and the intestine, that is, the brain-gut axis, plays a key role in the pathogenesis of IBS.

[0003] The brain-gut axis refers to the interaction and connection between the central nervous system and the gastrointestinal system. This bidirectional signal transmission mechanism involves the nervous, endocrine, and immune systems, enabling the brain to perceive the state of the intestine, and the intestine can in turn affect the function of the brain. In patients with IBS, the imbalance of the brain-gut axis may lead to intestinal dysfunction. Negative emotions such as stress, anxiety, or depression can directly affect the motility and perceptual function of the intestine through the neuroendocrine pathway, thus triggering the symptoms of IBS; while intestinal inflammation or microbial imbalance may also feedback to the brain through the immune and neural pathways, leading to central nervous system symptoms such as anxiety and depression; this mutually influential mechanism is called bidirectional influence.

[0004] Although there are currently various treatment methods for IBS, they all have certain limitations. Traditional drug treatments mainly include symptomatic treatment drugs, such as antidiarrheal drugs, laxatives, antispasmodics, and drugs for regulating intestinal motility, etc. Although these drugs can relieve the symptoms of patients to a certain extent, they often cannot improve the psychological disorders of patients. And psychotherapy has a certain effect on some IBS patients with psychological disorders, but the effect of using psychotherapy alone on improving intestinal physiological function is limited. For example, mesalazine is a drug commonly used to treat chronic enteritis such as inflammatory bowel diseases such as ulcerative colitis, and can effectively relieve the inflammation of the intestinal mucosa and reduce symptoms such as diarrhea, abdominal pain, and bloody stools. However, there is no obvious intestinal mucosal inflammation in IBS, and the anti-inflammatory effect of mesalazine on improving IBS symptoms is limited. Probiotics, as a class of live microorganisms, have unique advantages in regulating the intestinal microecological balance and have gradually come into people's view.

[0005] Oliva S et al. found in the study of "Randomised clinical trial: the effectiveness of Lactobacillus reuteri ATCC 55730 rectal enema in children with active distal ulcerative colitis." that Lactobacillus reuteri ATCC 55730 can effectively improve mucosal inflammation and improve the mucosal expression level of cytokines involved in the mechanism of inflammatory bowel disease, and has a certain curative effect on children with active distal ulcerative colitis. However, Niv E et al. confirmed in the study of "The efficacy of Lactobacillus reuteri ATCC 55730 in the treatment of patients with irritable bowel syndrome--a double blind, placebo-controlled, randomized study." that after probiotic treatment with Lactobacillus reuteri ATCC 55730, the symptoms of IBS patients did not improve. Different types of probiotics have differences in functional characteristics, so screening probiotic strains with specific functions and good application prospects is of great significance for the treatment of IBS.

[0006] Bifidobacterium longum subsp. infantis is one of the common beneficial bacteria in the human intestine, and its beneficial effects on human health have been widely studied. However, the current research on the therapeutic effect of Bifidobacterium longum subsp. infantis on irritable bowel syndrome still needs to be deepened, and there may be significant differences in the therapeutic effects of Bifidobacterium longum subsp. infantis from different sources or with different strain characteristics. Therefore, it is necessary to conduct in-depth research on specific strains of Bifidobacterium longum subsp. infantis to clarify its mechanism of action and application potential in the treatment of irritable bowel syndrome, and provide a scientific basis for the development of new, efficient and safe treatment methods for IBS.

[0007] In summary, the high incidence of irritable bowel syndrome and the limitations of existing treatment methods have prompted people to seek more effective treatment means, and the potential advantages of Bifidobacterium longum subsp. infantis in intestinal microecological regulation provide broad research space and application prospects for its application in the treatment of IBS. Summary of the Invention

[0008] In view of the above deficiencies, the present invention provides the use of Bifidobacterium longum subsp. infantis and its microecological preparation in the preparation of products for preventing and treating irritable bowel syndrome. The Bifidobacterium longum subsp. infantis described in the present invention is Bifidobacterium longum subsp. infantis B8762, and the preservation number is CGMCC No. 22765. This strain and its microecological preparation can be used to improve the IBS-SSS disease severity score of patients, improve the IBS-QOL quality of life of patients, reduce the PHQ-15 score of the somatization symptom scale in psychological assessment, and reduce the PHQ-12 score of the non-gastrointestinal somatization symptom scale, thereby improving the disease severity of patients and improving the quality of life. This strain and its microecological preparation can be used to prepare products for preventing, alleviating and / or treating irritable bowel syndrome.

[0009] The technical solution of the present invention is as follows:

[0010] On the one hand, the present invention provides the use of a Bifidobacterium longum subsp. infantis and its microecological preparation in the preparation of products for preventing and treating irritable bowel syndrome. The Bifidobacterium longum subsp. infantis is Bifidobacterium longum subsp. infantis B8762, and the preservation number is CGMCC No. 22765. The Bifidobacterium longum subsp. infantis B8762 has been disclosed in patent CN116083286B and is a strain preserved in the laboratory of the company.

[0011] Specifically, the dosage form of the microecological preparation includes solid dosage form, semi-solid dosage form or liquid dosage form.

[0012] Specifically, the microecological preparation includes one or more of the fermentation broth, fermentation broth supernatant, fermentation broth precipitate, live bacterial cells, dead bacterial cells, freeze-dried powder and cell lysate of Bifidobacterium longum subsp. infantis B8762.

[0013] Specifically, the microecological preparation includes Bifidobacterium longum subsp. infantis B8762 bacterial powder and / or Bifidobacterium longum subsp. infantis B8762 postbiotic bacterial powder.

[0014] Preferably, the Bifidobacterium longum subsp. infantis B8762 bacterial powder and / or Bifidobacterium longum subsp. infantis B8762 postbiotic bacterial powder contains at least 5.0×10 10 CFU / g or 5.0×10 10 Cells / g of Bifidobacterium longum subsp. infantis B8762.

[0015] More specifically, the preparation method of the Bifidobacterium longum subsp. infantis B8762 bacterial powder includes:

[0016] S1. Inoculate the activated Bifidobacterium longum subsp. infantis B8762 into a fermentation medium to obtain a seed solution;

[0017] S2. Inoculate the seed liquid into a fermentation medium for fermentation to obtain a fermentation broth.

[0018] S3. After concentrating the fermentation broth, add a cryoprotectant, and after freeze-drying, obtain the Bifidobacterium longum subsp. infantis B8762 bacterial powder.

[0019] Preferably, the fermentation medium described in step S1 includes: 23.5 kg of sucrose, 12.0 kg of lactose, 15.0 kg of soy peptone, 5.0 kg of yeast powder, 12 kg of yeast peptone, 21.0 kg of Na2HPO3, 2.0 kg of citric acid, 0.6 kg of MgSO4·7H2O, 0.3 kg of MnSO4·5H2O, 1.0 kg of Tween 80, 0.3 kg of L-cysteine hydrochloride, and 1000 L of distilled water.

[0020] Preferably, the inoculation amount of the seed liquid described in step S2 is 1‰ by volume fraction.

[0021] Preferably, the fermentation conditions described in step S2 are: maintain a constant temperature of 30 °C for the early stage of fermentation, and ferment naturally until the pH reaches 5.0; then adjust the fermentation temperature to 37 °C for constant temperature culture, and control the pH to remain at 6.0, maintaining anaerobic fermentation.

[0022] Further preferably, during the fermentation described in step S2, the pH is controlled by the method of dropwise adding a neutralizing agent.

[0023] Even further preferably, the neutralizing agent is a 25% NaOH solution.

[0024] Further preferably, the anaerobic fermentation conditions described in step S2 are achieved by purging nitrogen once every two hours.

[0025] Preferably, the cryoprotectant described in step S3 includes: 15 kg of skim milk, 12 kg of lactose, 1 kg of vitamin C, 1 kg of sodium glutamate, and make up to 1000 L with distilled water.

[0026] More specifically, the method for preparing the postbiotic bacterial powder of Bifidobacterium longum subsp. infantis B8762 includes:

[0027] (1) Inoculate the activated Bifidobacterium longum subsp. infantis B8762 into a fermentation medium to obtain a seed liquid;

[0028] (2) Inoculate the seed liquid into a fermentation medium for fermentation to obtain a fermentation broth;

[0029] (3) After heat treatment to sterilize and inactivate the fermentation broth, obtain an inactivated fermentation broth;

[0030] (4) Spray-dry the inactivated fermentation broth to obtain the postbiotic powder of Bifidobacterium longum subsp. infantis B8762.

[0031] Preferably, the fermentation medium described in step (1) includes: 23.5 kg of sucrose, 12.0 kg of lactose, 15.0 kg of soy peptone, 5.0 kg of yeast powder, 12 kg of yeast peptone, 21.0 kg of Na2HPO3, 2.0 kg of citric acid, 0.6 kg of MgSO4·7H2O, 0.3 kg of MnSO4·5H2O, 1.0 kg of Tween 80, 0.3 kg of L-cysteine hydrochloride, and 1000 L of distilled water.

[0032] Preferably, the inoculation amount of the seed liquid described in step (2) is 1‰ by volume fraction.

[0033] Preferably, the fermentation conditions described in step (2) are: incubate at a constant temperature of 30°C in the early stage of fermentation, and ferment naturally until the pH reaches 5.0; then adjust the fermentation temperature to 37°C and incubate at a constant temperature, and control the pH to remain at 6.0, and maintain anaerobic fermentation.

[0034] More preferably, during the fermentation process described in step (2), the pH is controlled by adding a neutralizing agent dropwise.

[0035] Even more preferably, the neutralizing agent is a 25% NaOH solution.

[0036] Further preferably, the anaerobic fermentation conditions described in step (2) are achieved by purging nitrogen once every two hours.

[0037] Preferably, the sterilization and inactivation conditions described in step (3) are 75°C for 15 minutes.

[0038] Specifically, the product includes one or more of health products and drugs.

[0039] Preferably, the product includes at least 2×10 10 CFU / g or 2×10 10 CFU / mL of Bifidobacterium longum subsp. infantis B8762.

[0040] More preferably, the product includes 2×10 10 -2×10 15 CFU / g or 2×10 10 -2×10 15 CFU / mL of Bifidobacterium longum subsp. infantis B8762.

[0041] Preferably, the product includes at least 1×10 11 Cells / g or 1×10 11Bifidobacterium longum subsp. infantis B8762 cells / mL.

[0042] Further preferably, the product includes 1×10 11 -1×10 15 Cells / g or 1×10 11 -1×10 15 Bifidobacterium longum subsp. infantis B8762 cells / mL.

[0043] Specifically, the drug further includes pharmaceutically acceptable excipients.

[0044] Preferably, the pharmaceutically acceptable excipients include solvents, diluents, disintegrants, precipitation inhibitors, surfactants, glidants, binders, lubricants, dispersants, suspending agents, isotonic agents, thickeners, emulsifiers, preservatives, stabilizers, hydrating agents, emulsification accelerators, buffers, absorbents, colorants, flavoring agents, sweeteners, ion exchangers, demolding agents, coating agents, flavor correctors or antioxidants.

[0045] Preferably, the dosage form of the drug includes tablets, pills, powders, suspensions, gels, emulsions, creams, granules, capsules, suppositories, injections, sprays or injections.

[0046] Specifically, the health product further includes nutritionally acceptable nutritional additives.

[0047] Preferably, the nutritional additives include one or more of dietary fiber, prebiotics, proteins, lipids, minerals, vitamins.

[0048] The beneficial effects of the present invention are as follows:

[0049] The Bifidobacterium longum subsp. infantis described in the present invention is Bifidobacterium longum subsp. infantis B8762, and the preservation number is CGMCC No. 22765. This strain and its probiotic preparations can be used to improve the IBS-SSS disease severity score of patients, improve the IBS-QOL quality of life of patients, reduce the PHQ-15 score of the somatic symptom group scale of psychological assessment, and reduce the PHQ-12 score of the non-gastrointestinal somatic symptom scale, thereby improving the disease severity of patients and improving the quality of life. This strain and its probiotic preparations can be used to prepare products for preventing, alleviating and / or treating irritable bowel syndrome. Detailed implementation mode

[0050] The following embodiments are provided to better understand the present invention further. It is not limited to the described optimal implementation mode, and does not limit the content and protection scope of the present invention. Any product that is the same as or similar to the present invention obtained by anyone under the inspiration of the present invention or by combining the features of the present invention with those of other prior arts falls within the protection scope of the present invention. For those embodiments where specific experimental steps or conditions are not indicated, the operations or conditions of the conventional experimental steps described in the literature in this field can be followed. For the reagents or instruments whose manufacturers are not indicated, they are all conventional reagent products that can be obtained through commercial purchase.

[0051] Example 1 Preparation of Bifidobacterium longum subsp. infantis B8762 Bacterial Powder

[0052] 1. Activation of the strain:

[0053] Inoculate Bifidobacterium longum subsp. infantis B8762 stored at -40°C into the improved MRS liquid medium sterilized at 121°C for 15 min, and anaerobically culture at 37°C for 24 h. After subculturing 2 times, the activated strain is obtained.

[0054] 2. Preparation of the optimized culture medium:

[0055] The composition of the optimized culture medium is as follows: 23.5 kg of sucrose, 12.0 kg of lactose, 15.0 kg of soy peptone, 5.0 kg of yeast powder, 12 kg of yeast peptone, 21.0 kg of Na2HPO3, 2.0 kg of citric acid, 0.6 kg of MgSO4·7H2O, 0.3 kg of MnSO4·5H2O, 1.0 kg of Tween 80, 0.3 kg of L-cysteine hydrochloride, and 1000 L of distilled water. Prepare each component of the optimized culture medium according to the proportion, mix evenly, adjust the pH value to 6.5, and sterilize at 121°C for 15 min.

[0056] 3. Preparation of the seed liquor:

[0057] Inoculate the activated strain obtained in step 1 into the optimized culture medium, and stop the anaerobic culture at 37°C when the pH value reaches 4.6 to obtain the seed liquor.

[0058] 4. Inoculation and fermentation:

[0059] Use the Bailun Biology BLBIO-10GJ fermenter for fermentation. Load 100 L of the optimized culture medium into the fermenter. After sterilization, inoculate the seed liquor obtained in step 3 into the optimized culture medium at a volume fraction of 1‰, and ferment for 18 h under the controlled fermentation conditions.

[0060] The fermentation conditions are controlled as follows: in the early stage of fermentation, it is cultured at a constant temperature of 30 °C and naturally ferments until the pH reaches 5.0; then the fermentation temperature is adjusted to 37 °C for constant temperature culture, and the pH is controlled to remain at 6.0, maintaining anaerobic fermentation. During the fermentation process, the pH is controlled by adding a neutralizing agent dropwise, and the neutralizing agent is a 25% NaOH solution; the anaerobic condition is achieved by purging nitrogen every two hours.

[0061] 5. Terminate fermentation:

[0062] When the acid production by the bacteria stops, the fermentation is terminated to obtain a high-density fermentation broth of the strain, and the viable cell count in the fermentation broth reaches 5×10 10 cfu / ml or more. Among them, it can be judged whether the acid production stops according to the fact that the pH no longer decreases and the addition of the neutralizing agent stops.

[0063] 6. Freeze-drying

[0064] (1) Bacterial cell concentration: The high-density fermentation broth is centrifuged at 12000g to concentrate the bacterial cells;

[0065] (2) Add protective agent: Add 5 times the protective agent solution to the concentrated bacterial cell solution; The composition of the protective agent solution is as follows: skim milk 15 kg, lactose 12 kg, vitamin C 1 kg, sodium glutamate 1 kg, and distilled water is made up to 1000 L.

[0066] (3) Drying: The above-mentioned bacterial suspension added with the protective agent is freeze-dried (model: Sihuan LGJ-12C) to obtain freeze-dried bacterial powder, which is the bacterial powder of Bifidobacterium longum subsp. infantis B8762, and the total viable cell count of the bacterial powder reaches 5.0×10 11 cfu / g or more.

[0067] Example 2 Preparation of postbiotic bacterial powder of Bifidobacterium longum subsp. infantis B8762

[0068] On the basis of Example 1, after completing step 5 to terminate fermentation, the following steps are carried out:

[0069] Inactivation: Mix maltodextrin according to production requirements (to provide an ideal liquid dispersion for spray drying), preheat to 58 °C, homogenize at a primary pressure of 19.0 Mpa and a secondary pressure of 5.0 Mpa, and then carry out sterilization inactivation. The parameter conditions for sterilization inactivation are 75 °C and 15 min;

[0070] Spray drying: The inactivated bacterial suspension is spray-dried (inlet air temperature 160 °C, outlet air temperature 45 °C) to obtain the postbiotic bacterial powder of Bifidobacterium longum subsp. infantis B8762.

[0071] Example 3 Preparation of bacterial agent of Bifidobacterium longum subsp. infantis B8762

[0072] Weigh 0.1 g of the Bifidobacterium longum subsp. infantis B8762 bacterial powder prepared in Example 1, add 0.9 g of the excipient maltodextrin, and mix evenly to obtain the Bifidobacterium longum subsp. infantis B8762 bacterial agent, with the viable bacteria count not less than 5.0×10 10 CFU / g.

[0073] Preparation of the Bifidobacterium longum subsp. infantis B8762 probiotic postbiotic agent in Example 4

[0074] Weigh 0.1 g of the Bifidobacterium longum subsp. infantis B8762 postbiotic bacterial powder in Example 2, add 0.9 g of the excipient maltodextrin, and mix evenly to obtain the Bifidobacterium longum subsp. infantis B8762 probiotic postbiotic agent, with the bacteria count not less than 5.0×10 10 Cells / g.

[0075] Therapeutic effect of Bifidobacterium longum subsp. infantis B8762 on irritable bowel syndrome in Example 5

[0076] 1. Experimental subjects

[0077] Recruit 184 patients diagnosed with irritable bowel syndrome (IBS) according to the Rome III criteria from the Inner Mongolia Autonomous Region People's Hospital. Exclude 15 people according to the inclusion and exclusion criteria, and 169 people are enrolled and randomly divided into two groups.

[0078] Inclusion criteria: (1) Voluntarily sign the informed consent form; (2) Gender is not limited, age is 18 - 70 years old; (3) The results of intestinal examinations (colonoscopy or barium meal radiography) are normal; (4) Symptoms have occurred for at least 6 months before diagnosis, and in the recent 3 months, it meets the following diagnosis: ① Abnormal defecation frequency (defecating > 3 times a day or < 3 times a week); ② Abnormal fecal characteristics (lumpy, hard stools or loose watery stools); ③ Abnormal fecal excretion process (straining, urgency, incomplete defecation); ④ Mucus in stools; ⑤ Flatulence or abdominal distension.

[0079] Exclusion criteria: (1) Women who are planning to get pregnant, pregnant or lactating women; (2) Those who are allergic to the test product or its components; (3) Those who have taken probiotic preparations within the recent 2 weeks; (4) Those with known cardiovascular diseases, renal insufficiency, malignant tumors, infectious diseases and other digestive tract diseases, diabetes or autoimmune diseases, etc., which are serious diseases considered by the researchers as not suitable for enrollment; (5) Patients with a history of abdominal surgery; (6) Those who have taken psychotropic drugs such as anti - anxiety and anti - depression drugs within the recent 1 month; (7) Subjects with major mental disorders, who have difficulty controlling their actions and cannot cooperate; (8) Subjects who are unwilling to provide personal information and do not wish to enter the study.

[0080] Discontinuation / Withdrawal Criteria: (1) If a change to other treatment is necessary during the observation period, the trial should be stopped, evaluation after sample intake completion and relevant laboratory tests should be conducted, and treatment should be carried out according to clinical routine. This case should be treated as a discontinued trial; (2) Use of drugs or preparations prohibited in the combined medication regulations; (3) The subject requests to withdraw voluntarily; (4) Loss to follow-up; (5) Withdrawal from the trial due to adverse reactions.

[0081] 2. Experimental Grouping

[0082] Live Bacteria Group (64 people): Continuous intervention for 90 days, taking Bifidobacterium longum subsp. infantis B8762 bacterial agent (2×10 10 CFU / stick / day) every day;

[0083] Postbiotics Group (55 people): Continuous intervention for 90 days, taking Bifidobacterium longum subsp. infantis B8762 probiotic postbiotics bacterial agent (1×10 11 Cells / stick / day) every day;

[0084] No Intervention Group (50 people): Continuous intervention for 90 days, taking maltodextrin with the same appearance, color, and weight every day.

[0085] 3. Detection Methods

[0086] Subjects were respectively intervened in the live bacteria group or the postbiotics group for 90 consecutive days. At day 0, 30, 60, and 90, questionnaires were conducted on the subjects (IBS disease severity score IBS-SSS, IBS patient quality of life score IBS-QOL, patient health questionnaire PHQ-15, non-gastrointestinal somatic symptom scale PHQ-12).

[0087] (1) IBS-SSS disease severity score, reference: Francis CY, Morris J, Whorwell Pi. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr; 11(2): 395-402.

[0088] The scoring indicators are as follows: Each of questions 1-5 has a full score of 100 points, and the option scores increase by 25 points in sequence, as shown in Table 1. Finally, the total score of this questionnaire is calculated. (IBS-SSS intestinal symptom severity classification: mild: 75-175; moderate: 175-300; severe: >300).

[0089] Table 1 IBS-SSS Disease Severity Scoring Criteria

[0090]

[0091] (2) IBS-QOL Irritable Bowel Syndrome Quality of Life Score, reference: Patrick DL, Drossman DA, Frederick IO, Dicesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure[J]. Dig Dis Sci, 1998;43(2):400-411.

[0092] The scoring indicators are as follows: It covers a total of 8 domains (34 items). The full score of each domain is 100 points. Each item is divided into 1-5 levels, and 1-5 points are assigned respectively. The total score ranges from 0 to 800 points. Finally, the total score of the questionnaire is calculated. The higher the score, the better the quality of life of the patient. See Table 2 for details.

[0093] Table 2 IBS-QOL Irritable Bowel Syndrome Quality of Life Scoring Criteria

[0094]

[0095]

[0096] (3) Psychological assessment of the somatic symptom cluster scale PHQ-15 score, reference: Spitzer, R.L., Krenke, K., & Williams, J.B. (1999). Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Jama, 282(18), 1737-1744.

[0097] The scoring indicators are as shown in Table 3. There are a total of 16 items. Each item is divided into 3 levels, and 0-2 points are assigned respectively. The total score ranges from 0 to 32 points.

[0098] Table 3 Psychological Assessment of Somatic Symptom Cluster Scale PHQ-15 Scoring Criteria

[0099]

[0100] (4) PHQ-12 score of non-gastrointestinal somatic symptom scale. References: Jones MP, Coppens E, Vos R, et al. A multidimensional model of Psychobiological interactions in functional dyspepsia: a structural equation modelling approach[J]. Gut, 2013, 62(11): 1573-80.

[0101] The scoring indicators are shown in Table 4, with a total of 13 items. Each item is divided into 3 levels, and scores of 0-2 are assigned respectively. The total score ranges from 0 to 26 points.

[0102] Table 4 Scoring criteria for PHQ-12 of gastrointestinal somatic symptom scale

[0103]

[0104] 4. Experimental results

[0105] (1) Comparison of IBS-SSS disease severity scores

[0106] As shown in Table 5, through the analysis of the IBS-SSS disease severity scores of the subjects, it was found that during the entire intervention period, the IBS-SSS scores of both the live bacteria group and the postbiotics group showed continuous improvement compared with the baseline (P<0.05), indicating that the intervention with Bifidobacterium longum subsp. infantis B8762 and its heat-inactivated bacteria can significantly relieve the disease severity of IBS patients.

[0107] Table 5 IBS-SSS disease severity scores of three groups of subjects

[0108] Blank group Live bacteria group Postbiotics group Baseline period <![CDATA[178.12±66.60 a > <![CDATA[175.63±70.15 a > <![CDATA[177.53±72.54 a > January <![CDATA[177.64±64.47 a > <![CDATA[131.25±60.66 b > <![CDATA[122.44±43.04 b > February <![CDATA[177.69±54.88 a > <![CDATA[112.50±84.96 b > <![CDATA[108.97±60.58 b > March <![CDATA[175.88±60.36 a > <![CDATA[105.00±74.83 b > <![CDATA[107.69±68.91 b >

[0109] Note: Data in the same column with the same superscript letter indicate no significant difference (P>0.05), while different letters indicate significant difference (P<0.05).

[0110] (2) Comparison of IBS-QOL quality of life scores in irritable bowel syndrome

[0111] As shown in Table 6, through the analysis of the IBS-QOL quality of life scores in irritable bowel syndrome, it was found that the IBS-QOL showed an upward trend during the entire intervention period, and there were significant differences compared with the baseline (P<0.05), indicating that the intervention with Bifidobacterium longum subsp. infantis B8762 and its heat-inactivated bacteria can significantly improve the quality of life of patients.

[0112] Table 6 IBS-QOL quality of life scores of three groups of subjects

[0113] Blank group Live bacteria group Postbiotics group Baseline period <![CDATA[664.12±56.46 a > <![CDATA[653.68±80.88 a > <![CDATA[667.04±102.63 a > January <![CDATA[667.64±60.16 a > <![CDATA[692.34±90.67 b > <![CDATA[719.96±63.86 b > February <![CDATA[667.60±61.32 a > <![CDATA[719.57±63.67 b > <![CDATA[729.72±75.51 b > March <![CDATA[666.62±59.19 a > <![CDATA[722.85±67.92 b > <![CDATA[732.16±63.86 b >

[0114] Note: For the data in the same column, the same superscript letter indicates no significant difference (P>0.05), and different letters indicate significant difference (P<0.05).

[0115] (3) Comparison of the scores of the PHQ-15 scale for somatic symptom clusters in psychological assessment

[0116] As shown in Table 7, through the analysis of the scores of the PHQ-15 scale for somatic symptom clusters in psychological assessment of the subjects, it was found that the scores of PHQ-15 showed a downward trend throughout the intervention period, and there were significant differences from the baseline (P<0.05). This indicates that the intervention with Bifidobacterium longum subsp. infantis B8762 and its heat-inactivated bacteria can significantly improve the disease severity and quality of life of patients.

[0117] Table 7 Scores of the PHQ-15 scale for somatic symptom clusters in psychological assessment of three groups of subjects

[0118] Blank group Live bacteria group Postbiotics group Baseline period <![CDATA[9.28±3.82 a > <![CDATA[9.30±4.35 a > <![CDATA[9.18±4.67 a > January <![CDATA[9.28±3.88 a > <![CDATA[7.35±3.61 b > <![CDATA[6.87±4.40 b > February <![CDATA[9.31±3.93 a > <![CDATA[6.68±3.98 b > <![CDATA[6.21±4.50 b > March <![CDATA[9.30±4.06 a > <![CDATA[6.05±4.11 b > <![CDATA[5.64±4.94 b >

[0119] Note: For the data in the same column, the same superscript letter indicates no significant difference (P>0.05), and different letters indicate significant difference (P<0.05).

[0120] (4) Comparison of the scores of the PHQ-12 scale for non-gastrointestinal somatic symptoms

[0121] As shown in Table 8, through the comparative analysis of the scores of the PHQ-12 scale for non-gastrointestinal somatic symptoms of the subjects, it was found that the scores of PHQ-12 showed a downward trend throughout the intervention period, and there were significant differences from the baseline (P<0.05). This indicates that the intervention with Bifidobacterium longum subsp. infantis B8762 and its heat-inactivated bacteria can significantly improve the disease severity and quality of life of patients.

[0122] Table 8 Scores of the PHQ-12 scale for non-gastrointestinal somatic symptoms of three groups of subjects

[0123] Blank group Live bacteria group Postbiotics group Baseline period <![CDATA[7.44±3.27 a > <![CDATA[7.46±3.58 a > <![CDATA[7.41±3.73 a > January <![CDATA[7.45±3.31 a > <![CDATA[5.69±3.13 b > <![CDATA[5.10±3.37 b > February <![CDATA[7.40±3.22 a > <![CDATA[5.03±3.20 b > <![CDATA[4.90±3.66 b > March <![CDATA[7.41±3.25 a > <![CDATA[4.82±3.43 b > <![CDATA[4.31±4.03 b >

[0124] Note: For the data in the same column, the same superscript letter indicates no significant difference (P>0.05), and different letters indicate significant difference (P<0.05).

[0125] 5. Conclusion

[0126] The bacterial agent prepared from the probiotic Bifidobacterium longum subsp. infantis B8762 can prevent, relieve, and / or treat irritable bowel syndrome, by improving the IBS-SSS disease severity score of patients, increasing the IBS-QOL quality of life of patients, reducing the PHQ-15 score of the somatization symptom cluster scale in psychological assessment, and reducing the PHQ-12 score of the non-gastrointestinal somatic symptom scale, thereby improving the disease severity of patients and enhancing the quality of life.

[0127] The above detailed description is a specific description of one of the feasible embodiments of the present invention, and this embodiment is not intended to limit the patent scope of the present invention. It should be noted that all equivalent implementations or changes made without departing from the present invention should be included within the scope of the technical solution of the present invention. Therefore, the protection scope of this invention patent shall be subject to the appended claims.

Claims

1. Use of Bifidobacterium longum subsp. infantis and its probiotic preparation in the manufacture of a product for preventing and treating irritable bowel syndrome, characterized in that, The Bifidobacterium longum subsp. infantis is Bifidobacterium longum subsp. infantis B8762, with the preservation number of CGMCC No. 22765.

2. The application according to claim 1, characterized in that, The dosage form of the microecological preparation includes solid dosage form, semi-solid dosage form or liquid dosage form.

3. The application according to claim 1, characterized in that, The microecological preparation includes one or more of the fermentation broth of Bifidobacterium longum subsp. infantis B8762, the supernatant of the fermentation broth, the precipitate of the fermentation broth, live bacterial cells, dead bacterial cells, freeze-dried powder and cell lysate.

4. The application according to claim 1, characterized in that, The microecological preparation includes the bacterial powder of Bifidobacterium longum subsp. infantis B8762 and / or the postbiotics bacterial powder of Bifidobacterium longum subsp. infantis B8762.

5. The application according to claim 4, wherein The Bifidobacterium longum subsp. infantis B8762 bacterial powder and / or the postbiotics powder of Bifidobacterium longum subsp. infantis B8762 contain at least 5.0×10 10 CFU / g of Bifidobacterium longum subsp. infantis B8762.

6. The application according to claim 4, characterized in that, The preparation method of the bacterial powder of Bifidobacterium longum subsp. infantis B8762 includes: S1. Inoculate the activated Bifidobacterium longum subsp. infantis B8762 into a fermentation medium to obtain a seed solution; S2. Inoculate the seed solution into a fermentation medium for fermentation to obtain a fermentation broth; S3. After concentrating the fermentation broth, add a cryoprotectant and freeze-dry to obtain the bacterial powder of Bifidobacterium longum subsp. infantis B8762.

7. The application according to claim 4, characterized in that The preparation method of the postbiotics bacterial powder of Bifidobacterium longum subsp. infantis B8762 includes: (1) Inoculate the activated Bifidobacterium longum subsp. infantis B8762 into a fermentation medium to obtain a seed solution; (2) Inoculate the seed solution into a fermentation medium for fermentation to obtain a fermentation broth; (3) After heat treatment to sterilize and inactivate the fermentation broth, obtain an inactivated fermentation broth; (4) Spray-dry the inactivated fermentation broth to obtain the postbiotics bacterial powder of Bifidobacterium longum subsp. infantis B8762.

8. The application according to claim 1, wherein The product includes one or more of health products and drugs.

9. The application according to claim 8, wherein The product includes at least 2×10 10 CFU / g or 2×10 10 CFU / mL of Bifidobacterium longum subsp. infantis B8762; or the product includes at least 1×10 11 Cells / g or 1×10 11 Cells / mL of Bifidobacterium longum subsp. infantis B8762.

10. The application according to claim 9, wherein The product includes 2×10 10 -2×10 15 CFU / g or 2×10 10 -2×10 15 Bifidobacterium longum subsp. infantis B8762 at CFU / mL; or the product includes 1×10 11 -1×10 15 Cells / g or 1×10 11 -1×10 15 Bifidobacterium longum subsp. infantis B8762 at Cells / mL.

11. The application according to claim 8, wherein, The drug also includes pharmaceutically acceptable excipients.

12. The application according to claim 11, wherein, The pharmaceutically acceptable excipients include solvents, diluents, disintegrants, precipitation inhibitors, surfactants, glidants, binders, lubricants, dispersants, suspending agents, isotonic agents, thickeners, emulsifiers, preservatives, stabilizers, humectants, emulsification accelerators, buffers, absorbents, colorants, flavoring agents, sweeteners, ion exchangers, demolding agents, coating agents, flavor correctors or antioxidants.

13. The application according to claim 8, characterized in that, The dosage form of the drug includes tablets, pills, powders, suspensions, gels, emulsions, creams, granules, capsules, suppositories, injections, sprays or injections.

14. The application according to claim 8, wherein The health product also includes nutritionally acceptable nutritional additives.

15. The application according to claim 12, characterized in that, The nutritional additives include one or more of dietary fiber, prebiotics, proteins, lipid substances, minerals and vitamins.

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