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The goal of this clinical trial is to learn the effect of Bifidobacterium animalis subsp. lactis Bi66 supplementation on gut function in healthy adults. The main questions it aims to answer are:
Participants will
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Bi66 | Experimental | Bi66 group adminster a sachet of probiotic powder (1 g), including Bifidobacterium animalis subsp. lactis Bi66 6.0 × 1010 CFU and a maltodextrin carrier once daily for 8 weeks. |
|
| Placebo | Placebo Comparator | Placebo group adminster a sachet of placebo powder (1 g) containing maltodextrin once daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | probiotic sachet mainly contains Bifidobacterium animalis subsp. lactis Bi66 and maltodextrin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel movement frequency | Bowel movement frequency per week will be measured by stool diary | From enrollment to the end of supplementation at 8 weeks |
| gut microbiota | The fecal microbiota will be measured using 16S rRNA gene amplicon sequencing and change in the composition of beneficial bacteria will be measured using Quantitative Real-time polymerase chain reaction. | Baseline, 4 weeks, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stool form | stool form will be measured by the Bristol Stool Scale (BSS) | From enrollment to the end of supplementation at 8 weeks |
| Fecal short-chain fatty acids | Fecal short-chain fatty acids will be measured by gas chromatography-mass spectrometry (GC-MS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liegang Liu, PhD | School of Public Health, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | Maltodextrin |
|
| Baseline, 4 weeks, 8 weeks |
| Inflammatory cytokine | Fasting plasma inflammatory cytokine, including CRP, IL-1β, IL-6, IL-8, IL-10, TNF-α, and IFN-γ will be measured by enzyme-linked immunosorbent assay (ELISA) | Baseline, 4 weeks, 8 weeks |
| D019602 |
| Food and Beverages |