The effect of Bacillus coagulans MTCC 5856(LactoSpore®) on the modulation of gut microflora and its fecal recovery in healthy human subjects: A randomized double blind placebo controlled clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1 Biomarkers
研究概览
简要总结
This prospective, randomized, double blind, placebo controlled clinical trial is designed to study the efficacy of Bacillus coagulans MTCC 5856 on modulation of gut microflora and its faecal recovery in healthy human subjects. The trial will be conducted in adult male and female healthy volunteers between 25 to 55 years and having body mass index between 20 to 27 kg/m2 (both inclusive). The individual subject participation will be for 28 days. The study aims at measuring the gastrointestinal survival of Bacillus coagulans and assessing its impact on faecal microflora. The study outcomes will include change in biomarkers, faecal sampling (RT-PCR and 16S Illumina based sequencing), subject abdominal life questionnaire and Bristol stool chart questionnaire. Statistical analysis will be performed as listed in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1 BMI between 20-27 kg/m2 (both inclusive).
- •2 Non vegetarians and Non smokers 3 Willing to come for regular follow –up visits.
- •4 Able to give written informed consent.
- •5 Willing to avoid the prebiotic and probiotic food supplements, laxatives and foods having laxative effects during the study.
排除标准
- •1 Use of antibiotics.
- •2 Any underlying gastrointestinal complaints like colonic irritation.
- •3 Not taking any medication with gastrointestinal activity like laxatives.
- •5 Consumption of Yogurt, curd, prebiotic or probiotic supplements as part of their daily diet.
- •6 Participation in a clinical study during the preceding 90 days.
- •7 Not willing to abide by the study procedures or not willing to provide stool samples for the study.
- •8 Pregnancy and lactating.
- •9 Presently suffering from any inflammatory disorders and mental illness.
- •10 History of drug or alcohol abuse in the last 6 months.
结局指标
主要结局
1 Biomarkers
时间窗: 1 Biomarkers(Visit2 and Visit4) | 2 Faecal Sampling(Visit2 and Visit4) | 3 Subject Abdominal Life Questionnaire(Visit2,Visit3 and Visit4) | 4 Bristol Stool Chart Questionnaire(Visit2 and Visit4)
4 Bristol Stool Chart Questionnaire
时间窗: 1 Biomarkers(Visit2 and Visit4) | 2 Faecal Sampling(Visit2 and Visit4) | 3 Subject Abdominal Life Questionnaire(Visit2,Visit3 and Visit4) | 4 Bristol Stool Chart Questionnaire(Visit2 and Visit4)
2 Faecal Sampling
时间窗: 1 Biomarkers(Visit2 and Visit4) | 2 Faecal Sampling(Visit2 and Visit4) | 3 Subject Abdominal Life Questionnaire(Visit2,Visit3 and Visit4) | 4 Bristol Stool Chart Questionnaire(Visit2 and Visit4)
3 Subject Abdominal Life Questionnaire
时间窗: 1 Biomarkers(Visit2 and Visit4) | 2 Faecal Sampling(Visit2 and Visit4) | 3 Subject Abdominal Life Questionnaire(Visit2,Visit3 and Visit4) | 4 Bristol Stool Chart Questionnaire(Visit2 and Visit4)
次要结局
- 1 Adverse and Serious adverse events(1 Adverse and Serious adverse events (Visit3 and Visit4))