CompletedNot Applicable

Bacillus Coagulans Based Product in IBS-Diarrhea

India50 participantsStarted 2023-02-25

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Male or female ≧ 18 - ≦ 65 years old. Signed informed consent. IBS-Diarrhea patient satisfying Rome III criteria. Male and female subjects in age range of 18 - 65 years and satisfying the Rome III Criteria for mild to moderate IBS-Diarrhea (IBS-D): Recurrent abdominal pain or discomfort, 3 days per month in the last 3 months (12 weeks), associated withmore than 2 of the criteria below. The criteria are fulfilled with symptoms onset 6 months prior to diagnosis Improvement with defecation. Onset associated with a change in stool frequency. Onset associated with a change in stool form (appearance). At least two of the following, at least a quarter of occasions or days (25%): Altered stool frequency (\> 3 bowel movements/day). Altered stool form (loose/watery stools). Altered stool passage (urgency or feeling of incomplete evacuation). Passage of mucus. Bloating or feeling of abdominal distention. Exclusion Criteria The patient will be excluded from the study if assessment by the treating investigator showed 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. Pregnant or lactating women. Females at child bearing age will be excluded unless they are using acceptable birth control…

What they're measuring

Change in IBS Symptom Severity Scale (IBS-SSS) score from baseline to Week 8 between intervention and placebo groups

Timeframe: Baseline to Week 8

Trial details

NCT IDNCT07520422

SponsorBioagile Therapeutics Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-25