Healthy Adult
Conditions
Keywords
probiotic, Bifidobacterium animalis subsp. lactis Bi66, bowel movement frequency, gut microbiota
Brief summary
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: 1. Does Bi66 affect the gut function(bowel movement frequency and stool form)? 2. Does Bi66 affect the gut microbiota and short-chain fatty acids ? Researchers will compare probiotic Bi66 to a placebo (a look-alike substance that contains no Bi66) to see if Bi66 works to affect gut function. Participants will 1. Take Bi66 or a placebo every day for 8 months 2. Return the used sachets and stool diaries every 7 days and record bowel movement frequency per week and Bristol Stool Scale 3. Have checkups, including questionnaire survey, physical measurement, dietary survey, collection and detection of biological samples at baseline, week 4, week 8
Interventions
DIETARY_SUPPLEMENTProbiotic
probiotic sachet mainly contains Bifidobacterium animalis subsp. lactis Bi66 and maltodextrin.
DIETARY_SUPPLEMENTPlacebo
Maltodextrin
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-65 years old; * Self-reported bowel movement frequency less than 5 times per week; * Change of weight no more than 3 kg within the last 2 months； * No consumption of probiotics, prebiotics, synbiotics within the last 2 months
Exclusion criteria
* Pregnant or breastfeeding women； * Smoking； * BMI \< 18 kg/m2 or ≥28 kg/m2； * Suffering from gastrointestinal disorders such as gastroenteritis, gastroduodenal ulcer, ulcerative colitis, Crohn's disease, intestinal stress syndrome, functional diarrhea, gastroparesis, etc； * History of gastrointestinal surgery (except appendectomy or hernia repair)； * Change in dietary habits within the last 1 month (e.g. ketogenic diet, etc.)； * History of major surgery within the last 3 months or major surgery planned in the next 1 month; * Use of antibiotics, acid-suppressing drugs, pro-digestive drugs (gastrointestinal, morpholine, cisapride, etc.), anti-constipation drugs, anti- diarrhea drugs, etc., in the last 1 month; * Participate in a similar intervention study within the last 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel movement frequency | From enrollment to the end of supplementation at 8 weeks | Bowel movement frequency per week will be measured by stool diary |
| gut microbiota | Baseline, 4 weeks, 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool form | From enrollment to the end of supplementation at 8 weeks | stool form will be measured by the Bristol Stool Scale (BSS) |
| Fecal short-chain fatty acids | Baseline, 4 weeks, 8 weeks | Fecal short-chain fatty acids will be measured by gas chromatography-mass spectrometry (GC-MS) |
| Inflammatory cytokine | Baseline, 4 weeks, 8 weeks | 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) |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLiegang Liu, PhD
School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed