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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Bacillus Coagulans
Placebo
Medstar Speciality Hospital
Bangalore, Karnataka, India
Change in IBS Symptom Severity Scale (IBS-SSS) score from baseline to Week 8 between intervention and placebo groups
Assessment of overall symptom relief in participants with IBS-D by comparing change in IBS Symptom Severity Scale (IBS-SSS) total score between the Bacillus coagulans group and placebo group over 8 weeks of treatment.
Time frame: Baseline to Week 8
Change in stool consistency and stool frequency from baseline to Week 8 between intervention and placebo groups
Assessment of stool consistency using Bristol Stool Form Scale (BSFS) and stool frequency (number of bowel movements per day) to compare changes between treatment groups during the study period.
Time frame: Baseline to Week 8
Change in hematological parameters from baseline to Week 8 between intervention and placebo groups
Assessment of changes in hematological laboratory parameters between intervention and placebo groups during the treatment period.
Time frame: Baseline to Week 8
Change in lipid profile biomarkers from baseline to Week 8 between intervention and placebo groups
Assessment of changes in lipid profile biomarkers, including serum lipid parameters, between intervention and placebo groups during the study period.
Time frame: Baseline to Week 8
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