Enrolling by invitation

Effects of Bacillus Coagulans-Based Probiotic on Gut Health and Immune Response in Healthy Adults

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Study Aim

This study investigates how a Bacillus Coagulans-based probiotic affects gut health and immune response in healthy adults.

What is being tested

Probiotic (Bacillus Coagulans)

+ Placebo

Dietary SupplementOther
Who is being recruted

From 18 to 50 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Placebo-Controlled
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorBioagile Therapeutics Pvt. Ltd.
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 10, 2025

Actual date on which the first participant was enrolled.

This clinical trial is a randomized, double-blind, placebo-controlled study that aims to evaluate the effects of a probiotic product based on Bacillus coagulans on gut health and immune responses in healthy adults. The study seeks to generate evidence on the role of Bacillus coagulans in maintaining gut balance and supporting immune function under normal conditions. The trial is important as it can help understand how probiotics might benefit overall health and well-being in healthy individuals. Participants in this study will be instructed to consume the assigned probiotic or placebo product twice daily, after meals, for the duration of the study. The effects of the probiotic will be assessed through various measures, including changes in fecal calprotectin levels, a well-established biomarker of gut inflammation. Additionally, selected immune and inflammatory markers, such as immunoglobulins, will be evaluated to understand the immunomodulatory effects. Participants will also report their gut health and immune status using validated questionnaires. Safety and tolerability of the probiotic product will be monitored throughout the study.

Official TitleA Prospective, Randomized, Double-blinded, Placebo-controlled Parallel Group-Clinical Trial Assessing Gut Health and Immunomodulatory Effects of Bacillus Coagulans Based Product in Healthy Adults
Principal SponsorBioagile Therapeutics Pvt. Ltd.
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Male or female, aged between 18 and 50 years.

Female participants are either not of childbearing potential, or females of childbearing potential agree to use a medically approved method of birth control and have a negative urine pregnancy test result.

In good general health, as determined by medical history, laboratory analysis, and physical examination performed by the study physician.

Willing to provide fecal samples as per the study requirements.

Show More Criteria

14 exclusion criteria prevent from participating
Subjects suffering from Gastrointestinal disease.

Subjects suffering from Chronic/iatrogenic Immunodeficiency.

Subjects suffering from Abnormal blood pressure.

Women who are pregnant or lactating.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Probiotic

Group II

Placebo
Placebo

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Advanced Gastro Care

Bangalore, IndiaOpen Advanced Gastro Care in Google Maps
Enrolling by invitationOne Study Center