Compositions, products and uses

Abstract

This application relates to compositions, products, and uses. The compositions comprise medium- and long-chain fatty acid triglycerides and *Bifidobacterium animalis* subsp. *lactobacter* BB-12, wherein, based on each gram of the medium- and long-chain fatty acid triglycerides, the viable count of *Bifidobacterium animalis* subsp. *lactobacter* BB-12 is 1.2 × 10⁻⁶. 7 CFU to 3 × 10 10 CFU. The composition has a synergistic effect in improving intestinal colic and / or bloating. This application also relates to the use of the composition in the preparation of products for improving intestinal colic and / or bloating.

Description

Technical Field

[0001] This application relates to compositions, products, and uses. Background Technology

[0002] Colic and bloating are common functional gastrointestinal symptoms with a high incidence in both infants and adults. Infantile colic is mainly characterized by paroxysmal, persistent crying without obvious cause, often accompanied by abdominal distension, increased flatulence, and other signs of discomfort, with an incidence rate of approximately 5% to 25%. Its onset may be related to factors such as immature gastrointestinal development, food intolerance, food allergies, or intestinal gas accumulation. Currently, the cause is unclear, and there is a lack of universally accepted effective prevention or treatment methods, causing significant distress to infants and their caregivers.

[0003] In adults, symptoms such as bloating and flatulence are also common and are closely related to lifestyle, psychological stress, and functional gastrointestinal disorders. More than half of the population has experienced gastrointestinal discomfort to varying degrees, with bloating being one of the most common manifestations, suggesting that such problems have a wide range of health impacts.

[0004] Current interventions for colic and bloating mainly include behavioral modifications, medication, or medical nutritional support. However, medication use in infants and young children requires extreme caution, while long-term medication use in adults may lead to side effects or adherence issues. Existing nutritional intervention programs are also mostly compound formulas, and their mechanisms of action are not yet clear, leaving room for improvement.

[0005] Intervening in gastrointestinal function through nutritional supplements offers advantages such as high safety, direct action, and ease of long-term adherence, making it particularly suitable for infants and young children, as well as individuals with limited drug tolerance. Therefore, developing a product or program that regulates intestinal function based on nutritional intake to alleviate discomfort symptoms such as colic and / or bloating is of significant practical importance. Summary of the Invention

[0006] To solve the above and other technical problems, the inventors conducted in-depth research and discovered that when medium- and long-chain fatty acid triglycerides are used in combination with Bifidobacterium animalis subsp. lactis BB-12 in a certain dosage ratio, they can synergistically regulate the intestinal function of the subjects, thereby improving discomfort symptoms such as intestinal colic and / or bloating.

[0007] In one aspect, this application provides a composition comprising medium- and long-chain fatty acid triglycerides and Bifidobacterium animalis subsp. lactis BB-12, wherein, based on each gram of the medium- and long-chain fatty acid triglycerides, the viable count of Bifidobacterium animalis subsp. lactis BB-12 is 1.2 × 10⁻⁶. 7 CFU to 3 × 10 10 CFU.

[0008] In some embodiments, the viable count of *Bifidobacterium animalis* subsp. *lactamase* BB-12 is 6 × 10⁻⁶ per gram of the medium- and long-chain fatty acid triglycerides. 7 CFU to 3 × 10 10 CFU.

[0009] In some embodiments, the viable count of *Bifidobacterium animalis* subsp. *lactamase* BB-12 is 6 × 10⁻⁶ per gram of the medium- and long-chain fatty acid triglycerides. 7 CFU to 3 × 10 8 CFU.

[0010] In another aspect, this application also provides a product comprising the composition according to any of the embodiments described above.

[0011] In some embodiments, the content of the medium- and long-chain fatty acid triglycerides is 0.1% to 30% (dry weight) based on the total dry weight of the product.

[0012] In some embodiments, the product is used to improve one or more of intestinal colic and bloating.

[0013] In another aspect, this application also provides the use of the composition described in any of the above embodiments in the preparation of a product for improving one or more of intestinal colic and bloating.

[0014] The beneficial effects of this application include: when medium- and long-chain triglycerides are used in combination with Bifidobacterium animalis subsp. lactis BB-12 at a certain dosage ratio, there is a synergistic effect between the two, which can synergistically regulate intestinal function, thereby improving intestinal colic and / or bloating. For example, when each gram of medium- and long-chain triglycerides is combined with a live bacteria count of 1.2 × 10⁻⁶, the effect is significant. 7 CFU to 3×10 10 When CFU is used in combination with Bifidobacterium animalis subsp. lactis BB-12, the composition synergistically regulates intestinal function, thereby improving intestinal colic and / or bloating. Preferably, when each gram of medium- and long-chain fatty acid triglycerides is combined with a viable count of 6 × 10⁻⁶ bacteria... 7 CFU to 3 × 10 10 When CFU is used in combination with Bifidobacterium animalis subsp. lactis BB-12, the synergistic effect of the composition is more significant, and it can synergistically regulate intestinal function, thereby improving intestinal colic and / or bloating. More preferably, when each gram of medium- and long-chain fatty acid triglycerides is combined with a viable count of 6 × 10⁻⁶ bacteria... 7 CFU to 3 × 10 8 When CFU is used in combination with Bifidobacterium animalis subsp. lactis BB-12, the synergistic effect of the composition is more significant, and it can further synergistically regulate intestinal function, thereby improving intestinal colic and / or bloating. Attached Figure Description

[0015] To enable a full understanding of this application and its easy implementation, exemplary embodiments will now be described by way of non-limiting examples, with reference to the accompanying drawings. In the drawings: Figure 1 The graph shows the total distance traveled by zebrafish after feeding or treatment, with comparisons made between each experimental group and the model control group. p <0.001; compared with Comparative Example 1, !! p <0.01, !!! p <0.001; compared with Comparative Example 2, ### p <0.001; compared with Comparative Example 3, @@@ p <0.001; compared with Comparative Example 4, $$ p <0.01, $$$ p <0.001; compared with Comparative Example 5, & p <0.05, &&& p <0.001; compared with Comparative Example 6, + p <0.05,++ p <0.001; Figure 2 It shows Figure 1 The diagram shown represents typical zebrafish behavior, where the black line represents the distance traveled at slow speed, the green line represents the distance traveled at medium speed, and the red line represents the distance traveled at fast speed. Figure 3 The graph shows the intestinal lumen area of ​​zebrafish after feeding or treatment, and compares each experimental group with the model control group. p <0.05, p <0.01, p <0.001; compared with Comparative Example 1, ! p <0.05, !!! p <0.001; compared with Comparative Example 2, ### p <0.001; compared with Comparative Example 3, @ p <0.05, @@@ p <0.001; compared with Comparative Example 4, $ p <0.05, $$ p <0.01, $$$ p <0.001; compared with Comparative Example 5, & p <0.05, && p<0.01; compared with Comparative Example 6, + p <0.05, ++ p <0.01; Figure 4 It shows Figure 3 The diagram shows the measurement of the intestinal lumen area of ​​a zebrafish. Detailed Implementation

[0016] To provide a clearer understanding of the technical features, objectives, and beneficial effects of this application, the technical solution of this application is described in detail below with reference to specific embodiments and accompanying drawings. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of this application. Unless otherwise specifically defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Furthermore, unless otherwise stated, all methods, steps, techniques, and operations not specifically detailed can and have been performed in a manner commonly known and understood by one of ordinary skill in the art.

[0017] Composition

[0018] In one aspect, this application provides a composition comprising medium- and long-chain fatty acid triglycerides and Bifidobacterium animalis subsp. lactis BB-12, wherein, based on each gram of the medium- and long-chain fatty acid triglycerides, the viable count of Bifidobacterium animalis subsp. lactis BB-12 is 1.2 × 10⁻⁶. 7 CFU to 3 × 10 10 CFU. The inventors surprisingly discovered that when the composition contains a defined ratio of medium- and long-chain fatty acid triglycerides and Bifidobacterium animalis subsp. lactis BB-12, it has a synergistic effect in improving intestinal colic. Additionally, it also has a synergistic effect in improving bloating.

[0019] As used herein, the term "medium-chain triglyceride" (MLCT) refers to a special type of triglyceride with a molecular structure containing both medium-chain and long-chain fatty acid residues. As used herein, the term "medium-chain fatty acid" refers to fatty acids with 6 to 12 carbon atoms in their carbon chain, such as hexanoic acid, heptanoic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, and dodecanoic acid. As used herein, the term "long-chain fatty acid" refers to fatty acids with 14 or more carbon atoms in their carbon chain, such as 14 to 30 carbon atoms, such as myristic acid, palmitic acid, oleic acid, linoleic acid, stearic acid, linolenic acid, arachidonic acid, eicosapentaenoic acid, docosapentaenoic acid, docosahexaenoic acid, and nervonic acid. As used herein, the terms "medium-chain triglyceride" (MCT) and "long-chain triglyceride" (LCT) refer to the esterification products of medium-chain fatty acids and long-chain fatty acids with glycerol, respectively.

[0020] Medium- and long-chain fatty acid triglycerides have attracted widespread attention as a star product among novel structured lipids. Their fatty acid composition is close to that of breast milk, which is beneficial for fat digestion and absorption. They can improve the absorption of lipid nutrients, inhibit the accumulation of body fat, and provide energy quickly and stably (Cheng, X). et al. Medium- and Long-ChainTriacylglycerol: Preparation, Health Benefits, and Food Utilization, Annu. Rev. Food Science and Technology 2024, 15, 381–408. Medium- and long-chain triglycerides have different physicochemical properties, metabolic characteristics, and nutritional value than long-chain or medium-chain triglycerides. Studies have shown that medium- and long-chain triglycerides are not simply equivalent to a physical mixture of long-chain and medium-chain triglycerides; the latter does not possess the physicochemical properties, metabolic characteristics, and nutritional value of the former (Yuan Tinglan. Composition and Metabolic Characteristics of Medium- and Long-Chain Triglycerides in Breast Milk Fat [D]. Wuxi: Jiangnan University, 2021).

[0021] As is known in the art, medium- and long-chain fatty acid triglycerides are produced by using edible vegetable oils and medium-chain triglycerides as raw materials, through transesterification reaction by lipase, followed by processes such as distillation, decolorization, and deodorization.

[0022] This application does not have any particular requirements regarding the medium- and long-chain triglycerides used; medium- and long-chain triglycerides commonly used in the art can be used. Medium- and long-chain triglycerides can be used in pure form or in a non-pure form rich in medium- and long-chain triglycerides. For example, the medium- and long-chain triglycerides used in the compositions of this application can be medium- and long-chain triglycerides with a single composition (i.e., each molecular chain has the same long-chain fatty acid residues and the same medium-chain fatty acid residues), or a mixture of medium- and long-chain triglycerides with two or more different compositions (i.e., each molecular chain has different long-chain fatty acid residues and / or different medium-chain fatty acid residues).

[0023] In some embodiments, the medium- and long-chain fatty acid triglycerides used in this application may contain C6-C6. 12 (e.g., C6, C7, C8, C9, C) 10 C 11 C 12 (or the range defined by either or both) fatty acid residues and C 14 ~C 30 (e.g., C) 14 C 15 C 16 C 17C 18 C 19 C 20 C 21 C 22 C 23 C 24 C 25 C 26 C 27 C 28 C 29 C 30 (or the range defined by either C6-C6) fatty acid residues. In some examples, C6-C6... 12 Fatty acid residues can originate from one or more of the following: hexanoic acid, heptanoic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, and lauric acid, etc. C 14 ~C 30 Fatty acid residues can be derived from one or more of the following: myristic acid, palmitic acid, heptadecanic acid, oleic acid, linoleic acid, stearic acid, nonadecanic acid, eicosapentaenoic acid, docosahexaenoic acid, docosapatraenoic acid, docosahexaenoic acid, tricarboxylic acid, tetracarboxyenoic acid, docosapentaenoic acid, docosahexaenoic acid, arachidonic acid, etc. In some examples, C6~C... 12 The fatty acid residues may be derived from one or more of the following: hexanoic acid, caprylic acid, decanoic acid, and lauric acid. In some examples, C... 14 ~C 30 Fatty acid residues may be derived from one or more of the following: myristic acid, palmitic acid, oleic acid, linoleic acid, stearic acid, linolenic acid, arachidonic acid, eicosapentaenoic acid, docosapentaenoic acid, and docosahexaenoic acid.

[0024] In some embodiments, the medium- and long-chain fatty acid triglycerides have C6~C6... 12 Fatty acid residues and C 14 ~C 30 The unit weight ratio of fatty acid residues can be from 0.124 to 2.000. For example, in the medium- and long-chain fatty acid triglycerides, C6~C6... 12 Fatty acid residues and C 14 ~C 30 The unit weight ratio of fatty acid residues may be 0.124, 0.125, 0.130, 0.140, 0.150, 0.160, 0.170, 0.180, 0.190, 0.200, 0.300, 0.400, 0.500, 0.600, 0.700, 0.800, 0.900, 1.000, 1.100, 1.200, 1.300, 1.400, 1.500, 1.600, 1.700, 1.800, 1.900, 2.000, or within the range defined by any two of these.

[0025] As used in this article, the term "Bifidobacterium animalis subsp. lactis BB-12" (Latin scientific name: Bifidobacterium animalis subs p. Lactis BB-12 This can be used interchangeably with "Bifidobacterium BB-12" or "BB-12". This strain belongs to the genus Bifidobacterium (Bifidobacterium). Bifidobacterium Bifidobacterium BB-12 is an anaerobic probiotic, isolated from dairy starter cultures by Chr. Hansen in 1983. It has effects such as regulating intestinal flora balance, enhancing immune regulation, and improving diarrhea and constipation. Currently, whether medium- and long-chain triglycerides can be used in combination with Bifidobacterium BB-12 to synergistically regulate intestinal function and thus synergistically improve intestinal colic and / or bloating requires further research.

[0026] In some embodiments of the composition described in this application, the viable count of *Bifidobacterium animalis* subsp. *lactamase* BB-12 is 6 × 10⁻⁶ per gram of the medium- and long-chain fatty acid triglycerides. 7 CFU to 3 × 10 10 CFU. When medium- and long-chain fatty acid triglycerides are used in combination with Bifidobacterium BB-12 in the amounts within the above range, the composition can exhibit a more significant synergistic effect, synergistically improving intestinal colic and / or bloating.

[0027] Preferably, based on each gram of the medium- and long-chain fatty acid triglycerides, the viable count of *Bifidobacterium animalis* subsp. *lactamase* BB-12 can be 6 × 10⁻⁶. 7 CFU to 3 × 10 8 CFU. When medium- and long-chain fatty acid triglycerides are used in combination with Bifidobacterium BB-12 in the amounts within the above range, the composition can exhibit a more significant synergistic effect, further synergistically improving intestinal colic and / or bloating.

[0028] product

[0029] In another aspect, this application also provides a product comprising the composition as described in any of the above embodiments.

[0030] All descriptions of the composition above apply here and will not be repeated here.

[0031] In some embodiments, the product may include or be a drug.

[0032] In some embodiments, the drug may be any dosage form, such as a solid dosage form (granules, powders, tablets, etc.) or a liquid dosage form. Furthermore, those skilled in the art will readily understand that, depending on the dosage form and application scenario, the drug may also include various pharmaceutically permissible excipients.

[0033] The products, such as pharmaceuticals, can be prepared using methods commonly employed in the art, which will not be elaborated upon here.

[0034] In some embodiments, the content of the medium- and long-chain fatty acid triglycerides is 0.1% to 30% (dry weight) based on the total dry weight of the product. As an example, the content of the medium- and long-chain fatty acid triglycerides may be 0.1%, 0.2%, 0.5%, 0.8%, 1.0%, 2.0%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, 8.0%, 9.0%, 10.0%, 11.0%, 12.0%, 13.0%, 14.0%, 15.0%, 16.0%, 17.0%, 18.0%, 19.0%, 20.0%, 21.0%, 22.0%, 23.0%, 24.0%, 25.0%, 26.0%, 27.0%, 28.0%, 29.0%, or 30.0% (dry weight), or within the range defined by any two of the above, based on the total dry weight of the product.

[0035] In some embodiments, the product can be used to regulate intestinal function. As used herein, the term "regulate" refers to improving, maintaining, or altering the state of intestinal function, including but not limited to relieving intestinal discomfort symptoms such as colic and bloating. In some examples, regulating intestinal function includes improving one or more of colic and bloating.

[0036] In some implementations, there are no particular limitations on the subjects (recipients) who are improving intestinal colic and / or bloating, and may include, for example, infants, toddlers, children, adolescents, adults, young adults, middle-aged people, and / or the elderly. As used herein, the term “infant” refers to a person aged from birth to 12 months; the term “toddler” refers to a person aged 1 to 3 years; the term “child” refers to a person aged 3 to 7 years; the term “adolescent” refers to a person aged 7 to 17 years; the term “adult” refers to a person aged 18 years or older; the term “young adult” refers to a person aged 18 to 40 years; the term “middle-aged person” refers to a person aged 41 to 65 years; and the term “elderly person” or “senior person” refers to a person aged 65 years or older.

[0037] use

[0038] In another aspect, this application also provides the use of the above-described composition according to any of the above embodiments in the preparation of products for improving one or more of intestinal colic and bloating.

[0039] All descriptions of the compositions and products described in this application above are applicable here and will not be repeated here.

[0040] Example

[0041] The present application will be more easily understood by referring to the following embodiments, which are only used to illustrate certain aspects and implementation methods of the present application and are not intended to limit the present application.

[0042] Unless otherwise stated, all materials used in this embodiment are commercially available or conventional materials.

[0043] Instruments, consumables and reagents

[0044] Dissecting microscope: SZX7, from OLYMPUS (Japan); Zebrafish behavior analysis system: Zebra Lab 3.22.3.31, from Viewpoint (France); 150 mm 25 mm petri dish: sourced from Orange Scientific (Belgium); 6-well plate: sourced from Zhejiang Beilanbo Biotechnology Co., Ltd. (China); 96-well plate: sourced from Nest Biotech (China); 2,4,6-Trinitrobenzenesulfonic acid (TNBS): sourced from Sigma (USA), lot number SLCN9362; Dimethyl sulfoxide (DMSO): sourced from Sigma (Switzerland), lot number BCCD8942; Medium- and long-chain triglycerides (MLCT): Medium- and long-chain fatty acid edible oil, MLCT purity is 61%, sourced from Yihai Kerry, production batch number 20250804; Bifidobacterium animalis subsp. lactis BB-12: sourced from Chr. Hansen Ltd., production batch number 3749554; Prednisolone: ​​a white powder, sourced from Shanghai Maclean Biochemical Technology Co., Ltd., batch number C10016501, solvent is DMSO.

[0045] laboratory animals

[0046] Zebrafish: Raised in fish farming water at 28°C (water quality: 200 mg of instant sea salt added per 1 L of reverse osmosis water, conductivity 450~550 μS / cm; pH 6.5~8.5; hardness 50~100 mg / L CaCO3), bred and provided by the fish farming center of Huante Biotechnology Co., Ltd., with laboratory animal use license number: SYXK (Zhejiang) 2022-0004, and husbandry management in accordance with the requirements of international AAALAC certification (certification number: 001458), IACUC ethics review number: IACUC-2025-202510290009-01.

[0047] In the following examples, the amounts and ratios of each component are based on the amount of the corresponding active ingredient. For example, Bifidobacterium BB-12 is based on the number of viable BB-12 bacteria contained in the BB-12 raw material; MLCT is based on the content of medium- and long-chain triglycerides in the long-chain fatty acid edible oil in the raw material.

[0048] Example 1: Evaluation of the efficacy of the composition in improving intestinal colic

[0049] Wild-type AB strain zebrafish, 3 days post-fertilization (3 dpf), were randomly selected and placed in culture dishes. Except for the normal control group, all other groups were given TNBS in water to establish a zebrafish colic model. After treatment at 28°C for 2 days, the TNBS was removed and the zebrafish were divided into 6-well plates with a volume of 3 mL per well, with 30 zebrafish in each treatment.

[0050] The samples were administered in water (concentrations shown in Table 1) as examples (MLCT + BB-12) or comparative examples (single-component MLCT or single-component BB-12); the positive control group was given prednisone at a concentration of 15.0 μg / mL; a normal control group (naïve, no treatment) and a model control group (intestinal colic model, no administration) were set up.

[0051] After treatment at 28°C for 2 days, 10 zebrafish were randomly selected from each group and placed in a behavior analyzer for 1 hour. The total movement distance of the zebrafish was analyzed, and the statistical analysis results of this index were used to evaluate the efficacy of the samples in improving intestinal colic. Statistical results are expressed as mean ± standard error (mean ± SE). Statistical analysis was performed using SPSS software, and p < 0.05 indicated statistical significance.

[0052] For each embodiment and comparative example, the increase in total movement distance (mm) compared to the model control group is calculated (denoted as A); and for each embodiment, the sum of the increase in total movement distance (mm) compared to the model control group for the corresponding comparative example is calculated (denoted as B). For example, for Example 1 (MLCT concentration 30 μg / mL + BB-12 concentration 9000 CFU / mL), the "sum of the increase in total movement distance compared to the model control group for the corresponding comparative example" is the sum of the "increase in total movement distance compared to the model control group" for Comparative Example 1 (MLCT concentration 30 μg / mL) and Comparative Example 4 (BB-12 concentration 9000 CFU / mL); and so on. Finally, the synergy coefficient is calculated (denoted as C, C=A / B). When the synergy coefficient > 1, a synergistic effect exists; the larger the value, the stronger the synergistic effect.

[0053] Following the above method, zebrafish were administered BB-12 and MLCT at different ratios to evaluate their efficacy in improving intestinal colic. The dosages are shown in Table 1. The results are also shown in Table 1. Figure 1 and Figure 2 As shown.

[0054] Table 1. Experimental results evaluating the efficacy of the samples in improving intestinal colic.

[0055] Note: Compared with the model control group, p <0.001; Compared with Comparative Example 1, !! p <0.01, !!! p <0.001; Compared with Comparative Example 2, ### p <0.001; Compared with Comparative Example 3, @@@ p <0.001; Compared with Comparative Example 4, $$ p <0.01, $$$ p <0.001; Compared with Comparative Example 5, & p <0.05, &&& p <0.001; Compared with Comparative Example 6, + p <0.05,++ p <0.001.

[0056] From Table 1, Figure 1 and Figure 2 The results showed that, compared with the normal control group, the total movement distance of zebrafish in the model control group was significantly reduced after induction with TNBS (P < 0.05), indicating that the TNBS-induced intestinal colic model was successfully established. The positive control drug (prednisone), single-component MLCT (750 μg / mL), single-component BB-12 (90,000 CFU / mL and 900,000 CFU / mL), and Examples 1-9 all significantly improved intestinal colic, specifically by significantly increasing the total movement distance compared with the model control group (P < 0.05).

[0057] Example 1 is a combination of MLCT (30 µg / mL) + BB-12 (9000 CFU / mL), wherein the viable count of BB-12 is 3.0 × 10⁻⁶ per gram of MLCT. 8CFU; Comparative Example 1 was a single-component MLCT (30 µg / mL); Comparative Example 4 was a single-component BB-12 (9000 CFU / mL), i.e., Example 1 is equivalent to a combination of Comparative Example 1 and Comparative Example 4. Compared with the model control group, the increase in total motility distance (A) of Example 1 was 1057 mm; the increases in total motility distance (A) of Comparative Example 1 and Comparative Example 4 were 78 mm and 119 mm, respectively, and the sum of the increases in total motility distance (B) of the two was 197 mm; it can be seen that the increase in total motility distance of Example 1 is much greater than the sum of the increases in total motility distance of Comparative Example 1 and Comparative Example 4, indicating that Example 1 has a synergistic effect in improving intestinal colic. Similarly, Examples 2 to 9 also showed a synergistic effect in improving intestinal colic. That is, when each gram of MLCT was combined with a live bacteria count of 1.2 × 10⁻⁶ CFU / mL, the effect was significantly greater. 7 CFU to 3.0 × 10 10 When CFU and BB-12 are used together, they have a synergistic effect in improving intestinal colic.

[0058] Furthermore, the synergistic effect can be further characterized by the synergistic coefficient. The synergistic coefficient reflects the strength of the synergistic effect of different doses of MLCT and BB-12. The higher the synergistic coefficient, the more significant the synergistic effect of the corresponding dose combination. For example, Examples 1 to 9 all have satisfactory synergistic coefficients (>1). In particular, Example 1 (BB-12 / MLCT = 3.0 × 10⁻⁶) 8 The synergy coefficient of CFU was 5.37, and in Example 4 (BB-12 / MLCT = 6.0 × 10⁻⁶), the synergy coefficient was 5.37. 7 The synergy coefficient of CFU was 5.31, both significantly greater than 1. This indicates that the synergy coefficients of Examples 1 and 4 are particularly high compared to other examples, suggesting that when the MLCT viable count is 6.0 × 10⁻⁶... 7 CFU to 3.0 × 10 8 When CFU and BB-12 are used together, their synergistic effect in improving colic is more significant.

[0059] Example II: Evaluation of the composition's efficacy in improving abdominal distension

[0060] Wild-type AB strain zebrafish with a 3-day pf growth rate were randomly selected and placed in culture dishes. Except for the normal control group, all other groups were treated with TNBS dissolved in water. After treatment at 28°C for 2 days, the TNBS was removed and the zebrafish were divided into 6-well plates with a volume of 3 mL per well, with 30 zebrafish in each treatment.

[0061] Samples were administered in water (concentrations shown in Table 2) as examples (MLCT + BB-12) or comparative examples (single-component MLCT or single-component BB-12); the positive control group was given prednisone 15.0 μg / mL; a normal control group and a model control group were also set up.

[0062] After two days of treatment at 28°C, ten zebrafish were randomly selected from each group, and images were taken and saved under a dissecting microscope. Data were collected using NIS-Elements D 3.20 advanced image processing software, and the intestinal lumen area of ​​the zebrafish was analyzed. The statistical analysis results of this index were used to evaluate the efficacy of the samples in improving abdominal distension in zebrafish. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software, and p < 0.05 was considered statistically significant.

[0063] For each embodiment and comparative example, the reduction in intestinal lumen area (pixels) compared to the model control group is calculated; and for each embodiment, the sum of the reductions in intestinal lumen area (pixels) of the corresponding comparative example compared to the model control group is calculated; then the synergy coefficient is calculated as described above.

[0064] Following the above method, zebrafish were administered BB-12 and MLCT at different ratios to evaluate their efficacy in improving abdominal distension. The dosages are shown in Table 2. The results are also shown in Table 2. Figure 3 and Figure 4 As shown.

[0065] Table 2. Experimental results evaluating the efficacy of the samples in improving abdominal distension.

[0066] Note: Compared with the model control group, p <0.05, p <0.01, p <0.001; Compared with Comparative Example 1, ! p <0.05, !!! p <0.001; Compared with Comparative Example 2, ### p <0.001; Compared with Comparative Example 3, @ p <0.05, @@@ p <0.001; Compared with Comparative Example 4, $ p <0.05, $$ p <0.01, $$$ p <0.001; Compared with Comparative Example 5, &p <0.05, && p <0.01; Compared with Comparative Example 6, + p <0.05, ++ p <0.01.

[0067] From Table 2, Figure 3 and Figure 4 The results showed that, compared with the normal control group, the intestinal lumen area of ​​zebrafish in the model control group was significantly increased after induction with TNBS in water. P <0.05 indicates successful modeling. The positive control drug (prednisone), single-component MLCT (750 μg / mL), single-component BB-12 (90000 CFU / mL and 900000 CFU / mL), and Examples 1-9 all significantly improved abdominal distension, specifically by a significant reduction in intestinal lumen area (pixels) compared to the model control. P <0.05).

[0068] Example 1 is a combination of MLCT (30 µg / mL) + BB-12 (9000 CFU / mL), wherein the viable count of BB-12 is 3.0 × 10⁻⁶ per gram of MLCT. 8 CFU; Comparative Example 1 was a single-component MLCT (30 µg / mL); Comparative Example 4 was a single-component BB-12 (9000 CFU / mL), i.e., Example 1 is equivalent to a combination of Comparative Example 1 and Comparative Example 4. Compared with the model control group, the reduction value (A) of intestinal lumen area in Example 1 was 9577 pixels; the reduction values ​​(A) of intestinal lumen area in Comparative Example 1 and Comparative Example 4 were 3288 pixels and 4062 pixels, respectively; the sum of the reduction values ​​(B) of the two was 7350 pixels. It can be seen that the reduction value of intestinal lumen area in Example 1 is greater than the sum of the reduction values ​​of intestinal lumen area in Comparative Example 1 and Comparative Example 4, and its synergy coefficient (C) was calculated to be 1.3 (>1), indicating that Example 1 has a synergistic effect in improving abdominal distension. Similarly, the synergy coefficient (C) of Examples 2-6, 8 and 9 are all greater than 1, thus also showing a synergistic effect in improving abdominal distension. In contrast, Example 7 (based on 1.2 × 10⁻⁶ viable bacteria per gram of MLCT) showed a viable count of 1.2 × 10⁻⁶. 7 The synergistic coefficient (C) of CFU was 0.97, indicating that its synergistic effect in improving abdominal distension was relatively weak. Therefore, it is evident that when MLCT per gram is combined with a live bacteria count of 6 × 10⁻⁶, the synergistic effect is not significant. 7 CFU to 3×10 10 When CFU and BB-12 are used together, they have a synergistic effect in improving bloating.

[0069] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A composition, characterized in that, The composition comprises medium- and long-chain fatty acid triglycerides and Bifidobacterium animalis subsp. lactis BB-12, wherein, based on each gram of the medium- and long-chain fatty acid triglycerides, the viable count of Bifidobacterium animalis subsp. lactis BB-12 is 1.2 × 10⁻⁶. 7 CFU to 3 × 10 10 CFU.

2. The composition according to claim 1, characterized in that, Based on each gram of the aforementioned medium- and long-chain fatty acid triglycerides, the viable count of *Bifidobacterium animalis* subsp. *lactamase* BB-12 is 6 × 10⁻⁶. 7 CFU to 3 × 10 10 CFU.

3. The composition according to claim 1, characterized in that, Based on each gram of the aforementioned medium- and long-chain fatty acid triglycerides, the viable count of *Bifidobacterium animalis* subsp. *lactamase* BB-12 is 6 × 10⁻⁶. 7 CFU to 3 × 10 8 CFU.

4. The product, characterized in that, The product comprises the composition according to any one of claims 1 to 3.

5. The product according to claim 4, characterized in that, The product is used to improve one or more of intestinal colic and bloating.

6. Use of the composition according to any one of claims 1 to 3 in the preparation of a product for improving one or more of intestinal colic and bloating.

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