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

A Prospective, Randomized, Double-blinded, Placebo-controlled Parallel Group-Clinical Trial Assessing Gut Health and Immunomodulatory Effects of Bacillus Coagulans Based Product in Healthy Adults

This randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the effects of a Bacillus coagulans-based probiotic product on gut health, immunological parameters, and overall tolerability in healthy adult participants. The study aims to generate clinical evidence on the role of Bacillus coagulans in maintaining intestinal homeostasis and modulating immune responses under normal physiological conditions.

Gut health will be assessed through both objective and subjective measures. Intestinal inflammation will be evaluated by measuring fecal calprotectin levels, a well-established biomarker of gut mucosal inflammation. Changes in fecal calprotectin from baseline to the end of the intervention period will be compared between the probiotic and placebo groups to determine the impact of the investigational product on gut inflammatory status.

The immunomodulatory effects of the study product will be evaluated by analyzing changes in selected immune and inflammatory markers, including immunoglobulins (IgA, IgG, and IgM). These parameters will be measured at baseline and at the end of the study to assess systemic immune responses associated with supplementation and to compare outcomes between the intervention and placebo groups.

In addition to laboratory-based assessments, participant-reported outcomes related to gut health and immune status will be captured using validated questionnaires, including the Gut Health Status Questionnaire (GHSQ) and the Immune Status Questionnaire (ISQ). These tools will be used to evaluate perceived overall relief and changes in gastrointestinal and immune-related well-being over the course of the study.

Safety and tolerability of the Bacillus coagulans-based product will be evaluated throughout the study duration by monitoring adverse events and other safety parameters in both the intervention and placebo groups, ensuring suitability of the product for use in a healthy population.

Participants will be instructed to consume the assigned study product twice daily, once in the morning and once in the evening after meals, for the duration of the intervention period. Compliance with study product intake will be documented by participants in a subject diary.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy Subjects (HS)
• Intervention / Treatment: Other: Placebo; Dietary supplement: Probiotic (Bacillus Coagulans)

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560018
      • Advanced Gastro Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female, aged between 18 and 50 years.
2. 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.
3. In good general health, as determined by medical history, laboratory analysis, and physical examination performed by the study physician.
4. Willing to provide fecal samples as per the study requirements.
5. Willing to participate voluntarily and provide written informed consent.

Exclusion Criteria:

1. Women who are pregnant or lactating.
2. Subjects who are taking Antibiotic treatment.
3. Subjects suffering from Gastrointestinal disease.
4. Subjects suffering from Diabetes.
5. Subjects suffering from Chronic/iatrogenic Immunodeficiency.
6. Subjects suffering from Abnormal blood pressure.
7. Subjects who are allergic to ingredients of the study Product.
8. Subjects who are Smoker or alcoholic.
9. Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months.
10. Women who are pregnant, breastfeeding, or planning to become pregnant.
11. Daily use of supplements that contain probiotics or prebiotics within 30 days prior to screening or during study.
12. Subjects with medical conditions affecting immune status (e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV) or taking medications that may impact the immune system, such as antibiotics, antimicrobials, or probiotic sachets.
13. Any surgical treatment within the previous three months or planned during the study.
14. Any subject, in the principal investigator's opinion, not considered suitable for enrolment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm II; Placebo	Other: Placebo; Placebo
Experimental: Arm I; Probiotic	Dietary supplement: Probiotic (Bacillus Coagulans); Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fecal calprotectin levels from baseline to the end of the study,	Fecal calprotectin concentration (µg/g) will be measured at baseline and at the end of the study. The change from baseline will be analyzed.	Baseline to Week 8 (or end of study)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in immunological markers (IgA, IgG, IgM) between baseline to the end of study	Immunological markers (IgA, IgG, IgM) will be measured at baseline and at the end of the study. The change from baseline will be analyzed	Baseline to week 8 (end of the study)
Change in Gut Health Status Questionnaire (GHSQ) Total score from baseline to End of the Study	The Gut Health Status Questionnaire (GHSQ) Total score will be assessed at the baseline and at the end of the study. The change from baseline will be analyzed	Baseline to week 8 (End of the Study)
Change in Immune Status Questionnaire (ISQ) Total Score from Baseline to End of the Study	The Immune Status Questionnaire (ISQ)total score will be assessed at the Baseline and at the end of the study. The change from Baseline will be analyzed	Baseline to week 8 (End of the Study)

Collaborators and Investigators

• Sponsor: Bioagile Therapeutics Pvt. Ltd.
• Investigators: Study Director: Parag Saudagar, S K Biobiz Private Limited

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2025
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): May 10, 2026

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Gut health and immunomodulatory effect
• Additional Relevant MeSH Terms: Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: BSP-25-073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No