None listed
Conditions
Interventions
Intervention1: Bacillus coagulans MTCC 5856 (LactoSpore®): One capsule containing 2 billion spores per day for 28 days
Control Intervention1: Placebo: One capsule containing Maltodextrin 200 mg per d
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 BMI between 20-27 kg/m2 (both inclusive). 2 Non vegetarians and Non smokers 3 Willing to come for regular follow â??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
Exclusion criteria: 1 Use of antibiotics. 2 Any underlying gastrointestinal complaints like colonic irritation. 3 Not taking any medication with gastrointestinal activity like laxatives. 4 Had not taken antibiotics for 3 months prior to starting the study. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Biomarkers 2 Faecal Sampling 3 Subject Abdominal Life Questionnaire 4 Bristol Stool Chart QuestionnaireTimepoint: 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
| Measure | Time frame |
|---|---|
| 1 Adverse and Serious adverse eventsTimepoint: 1 Adverse and Serious adverse events (Visit3 and Visit4) | — |
Countries
India
Contacts
Public ContactMr Shaji Paulose
Sami labs Limited
Outcome results
None listed