MedTrace Logo

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

NCT07377942 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-01-30

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Probiotics (Bacillus Subtilis)

Experimental

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Bioagile Therapeutics Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Parag Saudagar · S K Biobiz Private Limited

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2026-04-15
Completion
2026-05-10

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07377942 on ClinicalTrials.gov