Effect of Bifidobacterium Animalis Subsp. Lactis Bi66 Supplementation on Gut Function in Healthy Adults

N/ANot Yet RecruitingNCT06740500

Huazhong University of Science and Technology120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

120

Conditions

Healthy Adult

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bowel movement frequency

Bowel movement frequency per week will be measured by stool diary

Time frame: 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.

Time frame: Baseline, 4 weeks, 8 weeks

Secondary Outcomes

Stool form

stool form will be measured by the Bristol Stool Scale (BSS)

Time frame: 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)

Time frame: 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)

Time frame: Baseline, 4 weeks, 8 weeks

Effect of Bifidobacterium Animalis Subsp. Lactis Bi66 Supplementation on Gut Function in Healthy Adults

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts