To Evaluate the Effect of Bacillus Subtilis Based Product in Gut Health and Immunomodulatory Effect in Healthy Adults.

The goal of this clinical trial is to Assess Gut Health and Immunomodulatory Effects of Bacillus Subtilis based product in Healthy Adults The main question\[s\] it aims to answer are to assess the effects of Bacillus Subtilis on gut health in healthy adults by measuring changes in fecal calprotectin levels as a marker of intestinal inflammation, in comparison between the intervention and placebo group. To assess the immunomodulatory effects of Bacillus-Subtilis by measuring changes in inflammatory and immune response markers, in comparison between the intervention and placebo group To confirm the safety and tolerability of the study product Bacillus Subtilis in the healthy study population during the intended use, with safety assessments conducted across both the intervention and placebo groups. The primary and secondary outcomes are: Primary Efficacy Outcome: * Change in fecal calprotectin levels from baseline to the end of the study, comparing the intervention and placebo groups. * Changes in immunological markers (IgA, IgG, IgM) between baseline and study completion, comparing the intervention and placebo groups. Secondary Efficacy Outcome: • Improvement in the patient related overall relief, assessed using Gut Health Status Questionnaire (GHSQ) and Immune status questionnaire (ISQ) score with comparative analysis between the two groups. Participants will be asked to take the probiotics twice daily morning and evening after meals and record it in the subject diary.

NCT Number	NCT07377942
Lead Sponsor	Bioagile Therapeutics Pvt. Ltd.
Conditions	Healthy Participants Study
Enrollment	46 participants
Start Date	2025-09-16
Primary Completion	2026-04-15 (estimated)
Study Completion	2026-05-10 (estimated)
Updated on ClinicalTrials.gov	2026-01-30