NCT07377942

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

A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Gut Health and Immunomodulatory Effects of Bacillus Subtilis-based Product in Healthy Adults

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Bioagile Therapeutics Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Participants Study

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics (Bacillus Subtilis)	Experimental
OTHER	Placebo	Placebo

Timeline

• Start date: 2025-09-16
• Primary completion: 2026-04-15
• Completion: 2026-05-10
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

1 site across 1 country: India