A composition for intestinal health, method of preparation, use and related products

This composition, which combines oligosaccharides with a variety of probiotics in a specific ratio, addresses the inadequacy of gut microbiota regulation in infants and young children, significantly improves indigestion, constipation, and diarrhea, and restores gut health.

CN120167626BActive Publication Date: 2025-11-04BIOSTIME GUANGZHOU HEALTH PROD
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Patent Information

Application Number
CN202510340591.5
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-03-21
Publication Date
2025-11-04
Estimated Expiration
2045-03-21

AI Technical Summary

Technical Problem

Existing technologies lack effective comprehensive solutions to regulate the gut microbiota of infants and young children and improve intestinal discomfort symptoms such as indigestion, constipation or diarrhea. Furthermore, existing probiotics and prebiotics suffer from poor stability and limited efficacy.

Method used

The combination of oligosaccharides with probiotics such as Lactobacillus helveticus, Bifidobacterium longum subsp. infantis, Bifidobacterium longum subsp. longum, Bifidobacterium breve, Bifidobacterium bifidum, and Bifidobacterium animalis subsp. lactis in a specific ratio forms a composition that regulates the conditional pathogens in the intestinal tract of infants and young children and improves intestinal discomfort symptoms.

Benefits of technology

It significantly inhibits Staphylococcus aureus, Escherichia coli and Salmonella, improves problems such as abnormal stool shape, abnormal stool color and abnormal stool hardness caused by indigestion, constipation or diarrhea, restores the balance of intestinal flora and improves nutrient absorption.

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Abstract

The present application provides a composition for intestinal health, a preparation method, an application and related products, belonging to the field of food technology. The composition is composed of a mixed probiotic consisting of 9 selected probiotics and oligosaccharides; the oligosaccharides are composed of polydextrose, fructooligosaccharides and galactooligosaccharides. The composition can be made into a food that helps regulate the intestinal flora of infants. Bacterial culture experiments show that the composition significantly inhibits the growth of a variety of harmful bacteria. Human experiments show that the food can significantly improve the problems of indigestion, constipation or diarrhea of infants, and the abnormal stool shape, abnormal stool color, abnormal stool hardness and other problems caused by diarrhea.
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Description

Technical Field

[0001] This invention belongs to the field of food technology and relates to a composition, preparation method, application and related products for intestinal health. Specifically, it relates to a composition for improving the intestinal health of infants and young children, regulating intestinal flora and inhibiting harmful bacteria, as well as its preparation method and application. Background Technology

[0002] Infant gut health is crucial for their overall health and development, as the gut is the primary site for digestion and nutrient absorption. A healthy gut helps infants better absorb nutrients from food, promoting their growth and development. The gut is the largest immune organ in the human body, containing 70-80% of the body's immune cells. A healthy gut helps build and maintain an infant's immune system, reducing the risk of infections and allergic diseases.

[0003] However, infant gut health is affected by a variety of factors, including the overgrowth of opportunistic pathogens (such as Staphylococcus aureus, Escherichia coli, and Salmonella), and the resulting problems such as indigestion, constipation, and diarrhea. Current solutions for infant gut problems mostly focus on alleviating single symptoms, lacking comprehensive solutions that fully regulate the balance of the gut microbiota.

[0004] Infants' gut microbiota are still developing and are more sensitive to external interventions. Currently, commonly used methods for regulating gut microbiota include antibiotics, prebiotics, probiotics, and gut microbiota transplantation. However, these methods have several drawbacks: broad-spectrum antibiotics may lead to drug resistance; prebiotics generally have limited effectiveness and lack inhibitory effects against opportunistic pathogens; and probiotic preparations have poor stability during storage and in the acidic environment of the stomach.

[0005] Chinese invention patent CN117337992A discloses a probiotic prebiotic composition and its application, wherein the probiotic prebiotic composition comprises 2'-fucosylated lactose and Bifidobacterium bifidum (…). Bifidobacterium longum subsp. infantis R0071 and Bifidobacterium longum infantile subspecies ( Bifidobacterium longum subsp. infantis Made from R0033, it has the advantages of improving the gastrointestinal tract's resistance to pathogenic bacterial infections and reducing Salmonella colonization.

[0006] Chinese invention patent CN118830629A discloses a composition comprising human milk oligosaccharides and probiotics and its application in improving intestinal development. The human milk oligosaccharides are neutral fucosylated human milk oligosaccharides, and the probiotics are Bifidobacterium animalis. The composition can synergistically improve the development of the glycocalyx layer of intestinal epithelial cells. Good development of the glycocalyx layer prevents pathogen adhesion, provides favorable binding sites for symbiotic microorganisms, and further promotes the development of intestinal barrier function and intestinal development.

[0007] The article "Probiotics, Prebiotics and Their Health Benefits and Safety" (Hu Xuezhi, Shanghai Medicine, 2001, No. 8, pages 356-358) discloses that microecological agents can protect health by promoting intestinal flora balance, inhibiting intestinal putrefaction, promoting defecation, cleaning the intestinal environment, and improving the body's immunity. Microecological agents include probiotics and prebiotics. The beneficial bacteria in the human body are mainly bifidobacteria and acidophilic lactobacilli. Prebiotics are mainly some functional oligosaccharides such as fructooligosaccharides, isomaltose, lactulose, lactosucrose, xylooligosaccharides, stachyose, raffinose, soybean oligosaccharides, and sugar alcohols such as xylitol and lactitol.

[0008] In summary, although the prior art discloses that prebiotics and probiotics are used in combination to improve intestinal health, the ability to regulate intestinal pathogenic bacteria and improve intestinal discomfort symptoms such as abnormal stool form, abnormal stool color, and abnormal stool hardness caused by indigestion, constipation, or diarrhea in infants and young children still needs to be further improved. SUMMARY

[0009] To solve the problems in the prior art, the present application provides a composition for intestinal health, a preparation method thereof, and an application thereof. The present application uses oligosaccharides in combination with Lactobacillus helveticus, Bifidobacterium longum subsp. infantis, Bifidobacterium longum subsp. longum, Bifidobacterium breve, Bifidobacterium bifidum, and Bifidobacterium animalis subsp. lactis in a certain ratio to obtain a composition that can regulate intestinal pathogenic bacteria in infants and young children, prevent and / or improve intestinal discomfort such as indigestion, constipation, or diarrhea caused by abnormal stool form, abnormal stool color, and abnormal stool hardness.

[0010] To achieve the above-mentioned purposes, the technical solutions adopted by the present application are as follows:

[0011] In one aspect, the present application provides a composition for intestinal health, which is composed of 0.06-0.30 parts of mixed probiotics and 1.70-1.94 parts of oligosaccharides by weight;

[0012] The mixed probiotics are composed of Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, Bifidobacterium longum subsp. infantis M63, Bifidobacterium longum subsp. longum BB536, Bifidobacterium breve M-16V, Bifidobacterium bifidum R0071, Bifidobacterium animalis lactis HN019, Bifidobacterium animalis lactis Bi07 and Bifidobacterium animalis lactis Bb-12, with a ratio of live bacteria of 80-150:5-8:3-5:2-5:2-5:3-9:35-86.8:4-8:0.8-2; the oligosaccharides are composed of polydextrose, fructooligosaccharides and galactooligosaccharides, with a ratio of 0.97-1.32:0.5-0.7:0.05-0.2; the ratio of the total amount of live bacteria of the mixed probiotics to the weight of the composition is 4x10 9 -3x10 10 :1, in CFU: g.

[0013] As a specific example of the present application, the composition is composed of 0.06 parts of mixed probiotics and 1.94 parts of oligosaccharides by weight.

[0014] As a specific example of the present application, the composition is composed of 0.30 parts of mixed probiotics and 1.70 parts of oligosaccharides by weight.

[0015] Preferably, and as a specific example of the present application, the composition is composed of 0.13 parts of mixed probiotics and 1.87 parts of oligosaccharides by weight.

[0016] As a specific example of the present application, the ratio of the activity of Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, Bifidobacterium longum subsp. infantis M63, Bifidobacterium longum subsp. longum BB536, Bifidobacterium breve M-16V, Bifidobacterium bifidum R0071, Bifidobacterium animalis lactis HN019, Bifidobacterium animalis lactis Bi07 and Bifidobacterium animalis lactis Bb-12 is 150:5:5:2:2:3:35:4:0.8.

[0017] As a specific example of the present application, the ratio of the activity of Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, Bifidobacterium longum subsp. infantis M63, Bifidobacterium longum subsp. longum BB536, Bifidobacterium breve M-16V, Bifidobacterium bifidum R0071, Bifidobacterium animalis lactis HN019, Bifidobacterium animalis lactis Bi07 and Bifidobacterium animalis lactis Bb-12 is 80:8:3:5:5:9:86.8:8:2.

[0018] Preferably, and as a particular example of the application, the ratio of the viability of Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, Bifidobacterium longum subsp. infantis M63, Bifidobacterium longum subsp. longum BB536, Bifidobacterium breve M-16V, Bifidobacterium bifidum R0071, Bifidobacterium animalis subsp. lactis HN019, Bifidobacterium animalis subsp. lactis Bi07 and Bifidobacterium animalis subsp. lactis Bb-12 is 108:6.5:3.2:3.2:3.2:6.5:67.5:7.5:1.2.

[0019] As a particular example of the application, the ratio by weight of polydextrose, fructooligosaccharides and galactooligosaccharides is 1.32:0.50:0.05.

[0020] As a particular example of the application, the ratio by weight of polydextrose, fructooligosaccharides and galactooligosaccharides is 0.97:0.70:0.20.

[0021] Preferably, and as a particular example of the application, the ratio by weight of polydextrose, fructooligosaccharides and galactooligosaccharides is 1.17:0.6:0.1.

[0022] Preferably, the ratio of the total viable bacteria amount of the mixed probiotic to the weight of the composition is 4.77x10 9 -2.41x10 10 :1 CFU: g.

[0023] As a particular example of the application, the ratio of the total viable bacteria amount of the mixed probiotic to the weight of the composition is 4.7725x10 9 :1 CFU: g.

[0024] As a particular example of the application, the ratio of the total viable bacteria amount of the mixed probiotic to the weight of the composition is 2.4097x10 10 :1 CFU: g.

[0025] More preferably, the ratio of the total viable bacteria amount of the mixed probiotic to the weight of the composition is 10 10 -1.5x10 10 :1 CFU: g.

[0026] More preferably, and as a particular example of the application, the ratio of the total viable bacteria amount of the mixed probiotic to the weight of the composition is 1.034x10 10 :1 CFU: g.

[0027] In another aspect, the present application provides a method for preparing the above-mentioned composition, comprising the step of mixing Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, Bifidobacterium longum subsp. infantis M63, Bifidobacterium longum subsp. longum BB536, Bifidobacterium breve M-16V, Bifidobacterium bifidum R0071, Bifidobacterium animalis subsp. lactis HN019, Bifidobacterium animalis subsp. lactis Bi07, Bifidobacterium animalis subsp. lactis Bb-12, polydextrose, fructooligosaccharide and galactooligosaccharide.

[0028] In another aspect, the present application provides the use of the above-mentioned composition in the preparation of a probiotic product.

[0029] Preferably, the probiotic product is selected from one or more of the following:

[0030] (1) a probiotic product that helps modulate the intestinal flora;

[0031] (2) a probiotic product that improves the state of gastrointestinal discomfort;

[0032] (3) a probiotic product that prevents the state of gastrointestinal discomfort;

[0033] (4) a probiotic product that inhibits intestinal conditional pathogenic bacteria;

[0034] (5) a probiotic product that improves the state of stool.

[0035] More preferably, the probiotic product that improves the state of gastrointestinal discomfort is selected from one or more of the following:

[0036] a probiotic product that improves constipation;

[0037] a probiotic product that improves diarrhea;

[0038] a probiotic product that improves indigestion.

[0039] The term "indigestion" includes, but is not limited to, loss of appetite, bloating, belching, gastroesophageal reflux, incomplete digestion, etc.

[0040] More preferably, the probiotic product that prevents the state of gastrointestinal discomfort is selected from one or more of the following:

[0041] a probiotic product that prevents constipation;

[0042] a probiotic product that prevents diarrhea;

[0043] a probiotic product that prevents indigestion.

[0044] More preferably, the probiotic product that inhibits intestinal conditional pathogenic bacteria is selected from one or more of the following:

[0045] a probiotic product that inhibits Staphylococcus aureus;

[0046] Probiotic products for inhibiting E. coli;

[0047] Probiotic products for inhibiting Salmonella.

[0048] More preferably, the probiotic product for improving stool state is selected from one or more of the following:

[0049] Probiotic products for improving abnormal stool shape;

[0050] Probiotic products for improving abnormal stool color;

[0051] Probiotic products for improving abnormal stool hardness.

[0052] More preferably, the probiotic product for improving gastrointestinal discomfort state is a probiotic product for improving gastrointestinal discomfort state after 3 days of taking.

[0053] More preferably, the probiotic product is a probiotic product for use by infants and young children, and more preferably a probiotic product for use by infants and young children aged 0-6 years.

[0054] In a last aspect, the present application provides a product comprising the above-mentioned composition.

[0055] Compared with the prior art, the present application has the following beneficial effects:

[0056] The present application selects polydextrose, fructooligosaccharide, galactooligosaccharide, and 9 kinds of probiotics, i.e., Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, Bifidobacterium longum subsp. infantis M63, Bifidobacterium longum subsp. longum BB536, Bifidobacterium breve M-16V, Bifidobacterium bifidum R0071, Bifidobacterium animalis lactis HN019, Bifidobacterium animalis lactis Bi07, and Bifidobacterium animalis lactis Bb-12, as raw materials of the composition, and the composition is obtained by compounding the raw materials in a certain proportion, which can regulate intestinal condition pathogenic bacteria such as Staphylococcus aureus, E. coli, and Salmonella, and improve intestinal discomfort symptoms such as abnormal stool shape, abnormal stool color, and abnormal stool hardness caused by indigestion, constipation, or diarrhea. BRIEF DESCRIPTION OF DRAWINGS

[0057] Figure 1 Bar chart of improvement score of diarrhea symptoms in mice;

[0058] Among them, ** represents a significant difference compared with the model control group and p<0.01; *** represents a significant difference compared with the model control group and p<0.001; ns represents no significant difference compared with the model control group. DETAILED DESCRIPTION

[0059] Terms and statements of the present invention:

[0060] 1. The articles "a", "an", and "the": Unless otherwise expressly specified, include plural as well as singular objects.

[0061] 2. Numerical ranges: Unless otherwise expressly specified, all ranges or ratios disclosed herein are to be understood to be inclusive of any and all sub-ranges or sub-ratios subsumed therein. For example, a stated range or ratio of 1 to 30 should be considered to include any and all sub-ranges or sub-ratios between the minimum value of 1 and the maximum value of 30, including by way of example only, 3 to 17, 4 to 10, 9 to 20, 6 to 14, 5 to 35, 11 to 40, and 10 to 30, etc., as well as fractional and integral increments within the range of values and any whole number within the range of values.

[0062] The following non-limiting examples can provide a more complete understanding of the application to one of ordinary skill in the art, but are not intended to limit the scope of the application in any way. The following examples merely illustrate certain aspects of the application, and modifications and variations can be apparent to those of skill in the art from the disclosure without departing from the scope of the application.

[0063] The application is further described in the following specific examples.

[0064] The various chemical reagents used in the examples of the present application were obtained from conventional commercial sources unless otherwise specified. The amounts recited hereinafter are amounts by weight unless otherwise specified. It is understood that the recitations herein are made at room temperature unless otherwise specified.

[0065] The formulation of the MRS liquid medium used in the following examples is as follows:

[0066] Peptone 1%, sodium acetate 0.5%, beef extract 1%, glucose 2%, yeast extract 0.5%, Tween-80 0.1%, potassium phosphate dibasic 0.2%, magnesium sulfate 0.058%, diammonium citrate 0.2%, manganese sulfate 0.025%, and the balance being water, with a pH of 7.0 ± 0.2.

[0067] The preparation method of the LB solid medium used in the following examples is as follows:

[0068] Tryptone 10 g, yeast extract 5 g, sodium chloride 10 g, dissolved in water, and the pH is adjusted to 7.0 with 5M sodium hydroxide aqueous solution, and the volume is adjusted to 1 L with water. The LB liquid medium is obtained by high pressure sterilization, and then transferred into a culture dish while hot, and cooled to room temperature to obtain the LB solid medium.

[0069] In the following examples and comparative examples, the sources of some raw materials and strains are exemplarily illustrated as shown in Table 1.

[0070] Table 1

[0071]

[0072] Examples 1-5 provide a composition, the components of which are shown in Table 2 below:

[0073] Table 2

[0074]

[0075] Comparative Examples 1-6 provide a composition, the components of which are shown in Table 3 below ("-" means that the ingredient is not contained):

[0076] Table 3

[0077]

[0078] The method for preparing the composition in Examples 1-5 and Comparative Examples 1-6 is as follows: the components are mixed together in the amounts specified in the formulation, and the composition is obtained.

[0079] Effect Evaluation

[0080] 1. In vitro experiment of the composition on inhibition of Staphylococcus aureus, Escherichia coli, and Salmonella enteritidis.

[0081] 1.1 Detection process

[0082] The compositions provided in Examples 1-3, Comparative Example 2, Comparative Example 3, and Comparative Example 5 were inoculated into liquid MRS culture medium in a certain proportion, and incubated at 37°C overnight to obtain bacterial liquid (Examples 1-3, Comparative Example 2, Comparative Example 3, and Comparative Example 5).

[0083] Escherichia coli, Staphylococcus aureus, and Salmonella enteritidis were activated on LB solid plate culture medium, and incubated at 37°C for 24 h. Single colony bacterial lawns were picked and inoculated into the corresponding liquid culture medium and incubated overnight. Then, 1% of the bacterial liquid was inoculated into fresh culture medium for subculture to obtain activated bacterial liquid. 1 mL of the activated bacterial liquid was centrifuged (6000 rpm, 10 min) to discard the supernatant, and resuspended with an appropriate amount of sterile PBS to prepare Escherichia coli bacterial suspension, Staphylococcus aureus bacterial suspension, and Salmonella enteritidis bacterial suspension with a concentration of 10 8 CFU / mL, respectively.

[0084] LB agar liquid culture medium was prepared and cooled to about 55°C. Appropriate amounts of Escherichia coli bacterial suspension, Staphylococcus aureus bacterial suspension, and Salmonella enteritidis bacterial suspension were added to adjust the total concentration of the bacteria in the liquid culture medium to 10 6CFU / mL, then quickly pour into the pre-placed Oxford cup plate, after the medium cools and solidifies, take out the Oxford cup, respectively, in each well 200 μL of the bacteria liquid of Example 1-Example 3, Comparative Example 2, Comparative Example 3, Comparative Example 5 (adjust the bacteria liquid of each example, comparative example to a concentration of 10 8 CFU / mL). 200 μL of sterile MRS liquid medium as a blank control, after standing for 10 minutes, put into a 37℃ constant temperature incubator and incubate for 24h. Measure the diameter of the inhibition zone with a vernier caliper. Each group of experiments was repeated 5 times.

[0085] 1.2 Experimental results

[0086] The inhibition zone experiment results of the compositions provided by Example 1-Example 3, Comparative Example 2, Comparative Example 3, Comparative Example 5 on Escherichia coli, Staphylococcus aureus, Salmonella enteritidis are shown in Table 4 (average value ± standard deviation, n=5):

[0087] Table 4

[0088]

[0089] Wherein, aaaa represents that the data in the same column has a significant difference compared with Example 1 and p<0.0001.

[0090] As can be seen from Table 4, the ratio of the 9 kinds of probiotics (Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, Bifidobacterium longum subsp. infantis M63, Bifidobacterium longum subsp. longum BB536, Bifidobacterium breve M-16V, Bifidobacterium bifidum R0071, Bifidobacterium animalis lactis HN019, Bifidobacterium animalis lactis Bi07, Bifidobacterium animalis lactis Bb-12) provided by the present application can significantly improve the inhibition effect on Escherichia coli, Salmonella enteritidis and Staphylococcus aureus. In particular, the activity ratio of the 9 kinds of probiotics provided by Example 1 has better harmful bacteria inhibition effect compared with other activity ratios.

[0091] 2. Experiment of improving diarrhea symptoms of mice infected with Salmonella by the composition.

[0092] 2.1 Construction of mouse Salmonella typhi diarrhea model.

[0093] After the SPF level 6-week-old male Balb / c mice were adaptively fed for 1 week, the drinking water was changed to 5 mg / mL of streptomycin aqueous solution for 2 days, and then normal water and feed were used for feeding. After fasting and water deprivation for 4h, each mouse was given 100 μL of 5% sodium bicarbonate solution by gavage. Then each mouse was given 2×10 8 CFU of Salmonella typhi. Diarrhea was induced by continuous gavage of Salmonella typhi for 3 days.

[0094] 2.2 Grouping

[0095] The mice with diarrhea induced by oral gavage of Salmonella typhimurium were grouped.

[0096] Model control group: 200 μL of normal saline was orally gavaged to each mouse per day.

[0097] Positive control group: 200 μL of levofloxacin normal saline solution was orally gavaged to each mouse per day, and the dosage was 8 mg / kg of mouse weight.

[0098] Each example, comparative example group: 200 μL of the normal saline solution of the composition of the example / comparative example was orally gavaged to each mouse per day, and the dosage was 50 mg of the composition orally gavaged to each mouse per day. The oral gavage was continuously performed for 5 days.

[0099] In addition, the blank control group used the mice without the modeling diarrhea model to orally gavage the same amount of normal saline per day as the control.

[0100] 2.3 Experimental results

[0101] 2.3.1 Change in mouse weight

[0102] From the first day of administration, the weight of the mice was weighed per day, and the weighing was continuously performed for 5 days. The experimental results on the first day, the third day and the fifth day are shown in Table 5 (unit: g, mean ± standard deviation, n = 7):

[0103] Table 5

[0104]

[0105] Among them:

[0106] a indicates that the data in the same column has a significant difference compared with the model control group and p < 0.05; aa indicates that the data in the same column has a significant difference compared with the model control group and p < 0.01; aaa indicates that the data in the same column has a significant difference compared with the model control group and p < 0.001; aaaa indicates that the data in the same column has a significant difference compared with the model control group and p < 0.0001.

[0107] bb indicates that the data in the same column of Example 2-Example 5, Comparative Example 1-Comparative Example 7 has a significant difference compared with Example 1 group and p < 0.01; bbb indicates that the data in the same column of Example 2-Example 5, Comparative Example 1-Comparative Example 7 has a significant difference compared with Example 1 group and p < 0.001.

[0108] It can be seen that the composition provided by the present application can effectively alleviate the weight loss of the mice with salmonella diarrhea. During the administration, the composition of the present application works by the combination of probiotics and oligosaccharides, effectively inhibits the pathogenic bacteria, reduces the infection intensity, and makes the mice with diarrhea gradually recover. On the other hand, the combination of probiotics and oligosaccharides helps to rebuild the intestinal flora system and is beneficial to the absorption of nutrients, so that the weight loss caused by diarrhea is recovered. In particular, the composition provided in Example 1 has a significantly better improvement effect.

[0109] 2.3.2 Observation of the defecation state of the mice

[0110] On the 3rd day of administration, the diarrhea of the mice was evaluated in the form of fecal score. 0 points represent normal stool, 1 point represents mild diarrhea, and 2 points represent moderate diarrhea. The score results are shown in Table 2. Figure 1 It can be seen that the composition provided by the present application helps to alleviate the symptoms of diarrhea in mice, while Comparative Example 1 cannot achieve the effect of alleviating the symptoms of diarrhea as the composition of Example 1 of the present application.

[0111] 3. Experiment of the composition regulating the gastrointestinal discomfort symptoms of infants and young children.

[0112] 3.1 Subjects

[0113] A total of 85 infants and young children (0 months-6 years old) were recruited as subjects. The basic information of the subjects is shown in Table 6:

[0114] Table 6

[0115]

[0116] The parents of all the recruited subjects evaluated and fed back that the subjects were experiencing the symptoms of gastrointestinal discomfort (main symptoms including constipation, diarrhea and indigestion). The subjects took the composition provided in Example 1 (2 bags per day, 2 g per bag) for 3 consecutive days. The parents of the subjects participating in the experiment signed the informed consent form and guaranteed that they did not consume other products containing probiotics one month before the start of the experiment and at the start of the experiment.

[0117] 3.2 Evaluation method

[0118] ① In the following experiment, the shape and texture of the stool of infants and young children were evaluated according to the Bristol Stool Form Scale. The Bristol Stool Form Scale classifies stool into 7 types:

[0119] Type 1: Hard small pellets, difficult to expel, may be accompanied by constipation;

[0120] Type 2: Surface concave and convex sausage-shaped strip-shaped stool, difficult to expel, may also be accompanied by constipation;

[0121] Type 3: sausage-shaped stool with cracks on the surface, easy to expel;

[0122] Type 4: smooth and soft stool, which is the standard form of normal defecation;

[0123] Type 5: block-shaped stool with smooth cross-section, easy to expel, which is a variation within the normal range;

[0124] Type 6: paste-like stool, relatively thin, possibly accompanied by diarrhea;

[0125] Type 7: completely liquid stool, which is a manifestation of diarrhea.

[0126] Among them, Type 1 and Type 2 are constipation forms (hard stool), Types 3-5 are normal forms, and Types 6 and 7 are diarrhea forms (thin stool / watery stool).

[0127] ② In the following experiment, the severity of dyspepsia symptoms is defined as:

[0128] Mild dyspepsia: symptoms are present but mild, and do not affect daily life.

[0129] Moderate dyspepsia: symptoms are obvious and affect daily life, mental activity and state.

[0130] Severe dyspepsia: symptoms are obvious and unbearable, and affect growth and development.

[0131] ③ The data source of the following experiment is: a total of 85 subjects aged 0-6 years (including) were collected. Among them, 43 effective data of constipation symptoms, 19 effective data of diarrhea symptoms, and 44 effective data of dyspepsia symptoms.

[0132] In the following experimental results data, the statistical method of significant difference before and after using the composition adopts two-tailed t-test method. When P<0.1, there is a significant difference in data at the confidence level of 90%; when P<0.05, there is a significant difference in data at the confidence level of 95%.

[0133] 3.3 Improvement effect of the composition on constipation of infants and young children

[0134] Among the 85 subjects, a total of 43 subjects had different degrees of constipation. Among them, the number of subjects with constipation and not using paper diapers was 26, and the number of subjects with constipation and using paper diapers was 15.

[0135] The subject's parents recorded the length of each defecation, the number of defecations, the shape of the stool, and the color of the stool in the week before the subject used the composition, and then the subject took the composition provided in Example 1 (for 3 consecutive days). After 3 days, the subject's parents recorded the length of each defecation, the number of defecations, the shape of the stool, and the color of the stool in the 3 days after the subject used the composition, and determined whether the constipation had improved.

[0136] The improvement effect of the composition of Example 1 on infantile constipation is as follows.

[0137] (1) After the subjects used the test product for 3 consecutive days, 81.4% of the subject's parents reported that the constipation had improved.

[0138] (2) Compared before and after use, the subjects' defecation frequency and defecation length improved. The details are shown in Table 7.

[0139] Table 7

[0140]

[0141] wherein * represents a significant difference compared to before use and p < 0.05.

[0142] It can be seen that the subjects' average defecation frequency per week increased significantly by 32.5% (1.05 times / week). The subjects' average defecation length per time was significantly shortened by 35.6%.

[0143] (3) Compared before and after use, the subjects' stool shape and color improved.

[0144] For subjects who did not use paper diapers, as shown in Table 8:

[0145] Table 8

[0146]

[0147] For subjects who used paper diapers, as shown in Table 9:

[0148] Table 9

[0149]

[0150] 3.4 Improvement effect of the composition on infantile diarrhea

[0151] Among the 85 subjects, 19 had varying degrees of diarrhea. Among them, the number of subjects who had diarrhea and used paper diapers was 12.

[0152] The number of defecations, the number of times of occurrence of watery stool, and the stool color of the subjects were recorded by the parents of the subjects for one week before the subjects took the composition provided in Example 1 (for 3 consecutive days). After 3 days, the number of defecations, the number of times of occurrence of watery stool, and the stool color of the subjects were recorded by the parents of the subjects for 3 days after the subjects took the composition, and it was determined whether the constipation was improved.

[0153] The improvement effect of the composition of Example 1 on diarrhea of infants and young children is as follows.

[0154] (1) After the subjects used the test product for 3 consecutive days, 84.2% of the parents of the subjects reported that the diarrhea was improved.

[0155] (2) The number of defecations and the duration of defecation of the subjects were improved before and after use, and the results are shown in Table 10.

[0156] Table 10

[0157]

[0158] wherein * represents a significant difference compared to before use and p < 0.05.

[0159] As can be seen, the average number of defecations per day of the subjects was significantly reduced by 35.13% (1.11 times per day), and the average number of times of occurrence of watery stool per day was significantly reduced by 51.71% (1.36 times per day).

[0160] (3) The stool form and color of the subjects were improved before and after use.

[0161] For the subjects using a paper diaper, as shown in Table 11:

[0162] Table 11

[0163]

[0164] 3.5 Improvement effect of the composition on diarrhea of infants and young children

[0165] Among the 85 subjects, 44 subjects had different degrees of indigestion.

[0166] The parents of the subjects recorded the indigestion symptoms of the subjects for one week before the subjects took the composition provided in Example 1 (for 3 consecutive days). After 3 days, the parents of the subjects recorded the indigestion symptoms of the subjects for 3 days after the subjects took the composition, and it was determined whether the indigestion was improved.

[0167] The improvement effect of the composition of Example 1 on indigestion of infants and young children is as follows.

[0168] (1) After the subjects continuously used the test product for 3 days, 77.3% of the parents of the subjects fed back that the indigestion was improved.

[0169] (2) Compared before and after use, the proportion of subjects who had indigestion symptoms decreased, as shown in Table 12.

[0170] Table 12

[0171]

[0172] (3) Compared before and after use, the parents of the subjects fed back that the moderate indigestion symptoms of the infants were improved.

[0173] ① The proportion of people who fed back moderate loss of appetite decreased by 43.2%;

[0174] ② The proportion of people who fed back moderate abdominal distension / belching / farting decreased by 27.2%;

[0175] ③ The subjects who fed back moderate vomiting / vomiting (regurgitation / milk overflow) were all converted to mild or asymptomatic;

[0176] ④ The subjects who fed back moderate repeated crying / abdominal pain were all converted to mild or asymptomatic;

[0177] ⑤ The proportion of people who fed back moderate feces with milk pieces or undigested food residues decreased by 22.7%.

[0178] (4) Compared before and after use, the parents of the subjects fed back that the severe indigestion symptoms of the infants were improved: the subjects with severe indigestion and feces with milk pieces or undigested food residues were all converted to mild or asymptomatic.

[0179] 3.6 Overall Evaluation

[0180] Based on the evaluation of subjects aged 0-6 years (including) (N=85), after the subjects continuously used the composition provided in Example 1 for 3 days:

[0181] (1) 78.8% of the parents of the subjects fed back that at least one intestinal problem of the subjects, such as constipation, diarrhea, or indigestion, was improved.

[0182] (2) Compared before and after use, most of the parents of the subjects fed back that the sleep quality and mental state of the subjects were significantly improved.

[0183] (3) Compared before and after use, the proportion of people with normal weight growth increased by 17.7%.

[0184] 3.7 Evaluation Conclusion

[0185] According to the test of the composition of Example 1, the test results of 3 days of use by a total of 85 subjects aged 0 months to 6 years (inclusive) who were experiencing symptoms of gastrointestinal discomfort (main symptoms including constipation, diarrhea, and indigestion) according to feedback from parents were as follows:

[0186] (1) Relieving symptoms of constipation, diarrhea, and indigestion.

[0187] (2) 81.4% of parents recognized improvement in constipation.

[0188] (3) 84.2% of parents recognized improvement in diarrhea.

[0189] (4) 77.3% of parents recognized improvement in indigestion.

[0190] (5) 78.8% of parents recognized improvement in at least one of the symptoms of constipation, diarrhea, and indigestion.

[0191] Finally, it should be noted that the above content is only used to illustrate the technical solutions of the present application, and is not a limitation on the protection scope of the present application. Simple modifications or equivalent replacements of the technical solutions of the present application made by those skilled in the art do not deviate from the essence and scope of the technical solutions of the present application.

Claims

1. A composition for gut health, characterized in that, The composition consists of 0.06-0.30 parts of mixed probiotics and 1.70-1.94 parts of oligosaccharides by weight; The mixed probiotics consist of Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, Bifidobacterium longum subsp. infantis M63, Bifidobacterium longum subsp. longum BB536, Bifidobacterium breve M-16V, Bifidobacterium bifidum R0071, Bifidobacterium animalis lactis HN019, Bifidobacterium animalis lactis Bi07 and Bifidobacterium animalis lactis Bb-12 in a ratio of 80-150:5-8:3-5:2-5:2-5:3-9:35-86.8:4-8:0.8-2 by live bacterial amount; The oligosaccharides consist of polydextrose, fructooligosaccharides and galactooligosaccharides in a ratio of 0.97-1.32:0.5-0.7:0.05-0.2 by weight; The ratio of the total viable count of the mixed probiotic to the weight of the composition is 4 x 10 9 -3 x 10 10 :1 CFU: g.

2. The composition of claim 1, wherein, The ratio of live bacterial amount of Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, Bifidobacterium longum subsp. infantis M63, Bifidobacterium longum subsp. longum BB536, Bifidobacterium breve M-16V, Bifidobacterium bifidum R0071, Bifidobacterium animalis lactis HN019, Bifidobacterium animalis lactis Bi07 and Bifidobacterium animalis lactis Bb-12 is 108:6.5:3.2:3.2:3.2:6.5:67.5:7.5:1.

2.

3. The composition of claim 1, wherein, The ratio of polydextrose, fructooligosaccharides and galactooligosaccharides by weight is 1.17:0.6:0.

1.

4. The composition of claim 1, wherein, The ratio of the total viable count of the mixed probiotic to the weight of the composition is 4.77 x 10 9 -2.41 x 10 10 :1, in CFU: g.

5. Process for the preparation of a composition according to any one of claims 1 to 4, characterized in that, The method comprises the following steps: Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, Bifidobacterium longum subsp. infantis M63, Bifidobacterium longum subsp. longum BB536, Bifidobacterium breve M-16V, Bifidobacterium bifidum R0071, Bifidobacterium animalis lactis HN019, Bifidobacterium animalis lactis Bi07, Bifidobacterium animalis lactis Bb-12, polydextrose, fructooligosaccharides and galactooligosaccharides are mixed.

6. Use of the composition of any one of claims 1-4 in the preparation of a probiotic product.

7. Use according to claim 6, characterized in that, The probiotic product is selected from one or more of the following: (1) a probiotic product for helping to regulate intestinal flora; (2) a probiotic product for improving intestinal discomfort; (3) a probiotic product for preventing intestinal discomfort; (4) a probiotic product for inhibiting intestinal conditional pathogenic bacteria; (5) a probiotic product for improving stool condition.

8. Use according to claim 7, characterized in that, The probiotic product for improving intestinal discomfort is a probiotic product for improving intestinal discomfort after 3 days of taking.

9. A product characterized by, The method comprises the composition of any one of claims 1-4.

Citation Information

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