A study to assess the effects of Bacillus coagulans-based productin patients with IBS-Diarrhea
- Conditions
- Health Condition 1: K580- Irritable bowel syndrome with diarrhea
- Registration Number
- CTRI/2023/01/048644
- Lead Sponsor
- Abode Biotec India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or female
2.18 - 65 years old
3.Signed informed consent
4.IBS-Diarrhea patient satisfying Rome III criteria.
1.The patient will be excluded from the study if assessment by the treating investigator showed an evidence for cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, head, ears, eyes, nose and throat, dermatologic/psychiatric, allergy, major surgery or other diseases as revealed by history, physical examination and existing laboratory assessments which may interfere with the administration
2.Pregnant or lactating women.
3.Females at childbearing age will be excluded unless they are using acceptable birth control measures (i.e. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence or a vasectomized partner).
4.Exercise and the use of complementary and alternative medicine for IBS symptoms (i.e. peppermint oil, cognitive behavior therapy) during the study should be maintained at the same level prior to the study.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in the overall symptoms relief <br/ ><br>between the intervention group and the placebo <br/ ><br>group as assessed by IBS SSSTimepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method 1.Difference in hematological parameters and lipid profile biomarkers in-between 2 groups over the study period. <br/ ><br>2.Differences in stool consistency and frequency per day in-between 2 groups over the study periodTimepoint: 8 weeks