In this study the effectiveness of probiotic on the microflora of the stomach and its recovery in the stools will be studied in healthy individuals in comparison to an inactive.

Not yet recruiting

• Conditions: Age between 25-55 years and BMI between 20-27 kg/m2 (both inclusive)

• Registration Number: CTRI/2018/10/015913
• Lead Sponsor: Sami Labs Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-10-10
• Study Start: 2018-12-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Biomarkers	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	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	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	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)

Secondary Outcome Measures

Name	Time	Method
1 Adverse and Serious adverse events	1 Adverse and Serious adverse events (Visit3 and Visit4)

Trial Locations

Locations (1)

Divakars Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Divakars Speciality Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Hema Divakar

Principal investigator

9900154448

divakarsspecialityhospital@gmail.com