Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07520422
NA

Bacillus Coagulans Based Product in IBS-Diarrhea

Sponsor: Bioagile Therapeutics Pvt. Ltd.

View on ClinicalTrials.gov

Summary

This is a prospective, randomized, double-blind, placebo-controlled, parallel-group interventional clinical trial designed to evaluate the efficacy and safety of a Bacillus coagulans-based product in adult patients with mild to moderate Irritable Bowel Syndrome with predominant diarrhea (IBS-D), diagnosed according to Rome III criteria. A total of 50 eligible male and female participants aged 18 to 65 years will be randomized in a 1:1 ratio to receive either Bacillus coagulans capsules or matching placebo for 8 weeks. The investigational product contains Bacillus coagulans (10⁶-10⁸ CFU) administered orally twice daily, morning and evening. The primary objective is to assess the effect of the study product on IBS-D symptoms, including abdominal pain, gastrointestinal symptom severity, stool consistency, and stool frequency, using validated assessment tools such as Abdominal Pain Visual Analogue Scale (VAS), IBS Symptom Severity Scale (IBS-SSS), and Bristol Stool Form Scale (BSFS). Secondary assessments include changes in hematological parameters and lipid profile biomarkers, along with safety monitoring through vital signs and adverse event reporting. Participants will attend four study visits: screening, baseline, Week 4, and Week 8. Weekly symptom recordings for abdominal pain and stool characteristics will be documented using participant diary cards throughout the treatment period.

Official title: A Prospective, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Effects of a Bacillus Coagulans-based Product in Patients With IBS-Diarrhea.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-02-25

Completion Date

2023-05-25

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Probiotic Arm

Bacillus Coagulans

OTHER

Placebo

Placebo

Locations (1)

Medstar Speciality Hospital

Bangalore, Karnataka, India