NCT06740500已完成不适用
Effect of Bifidobacterium Animalis Subsp. Lactis Bi66 Supplementation on Gut Function in Healthy Adults: a Double-blind Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Bowel movement frequency
研究概览
简要总结
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:
- Does Bi66 affect the gut function(bowel movement frequency and stool form)?
- 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
- Take Bi66 or a placebo every day for 8 months
- Return the used sachets and stool diaries every 7 days and record bowel movement frequency per week and Bristol Stool Scale
- Have checkups, including questionnaire survey, physical measurement, dietary survey, collection and detection of biological samples at baseline, week 4, week 8
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pregnant or breastfeeding women；
- •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
结局指标
主要结局
Bowel movement frequency
时间窗: From enrollment to the end of supplementation at 8 weeks
Bowel movement frequency per week will be measured by stool diary
gut microbiota
时间窗: 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.
次要结局
- Stool form(From enrollment to the end of supplementation at 8 weeks)
- Fecal short-chain fatty acids(Baseline, 4 weeks, 8 weeks)
- Inflammatory cytokine(Baseline, 4 weeks, 8 weeks)
研究者
Liegang Liu
Professor
Huazhong University of Science and Technology
研究点 (1)
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