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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy Participants Study
• Intervention / Treatment: Other: Placebo; Dietary supplement: Probiotics (Bacillus Subtilis)

• 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: Placebo	Other: Placebo; Placebo
Experimental: Probiotics; Bacillus subtilis	Dietary supplement: Probiotics (Bacillus Subtilis); 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
Change in Gut Health Status Questionnaire (GHSQ) Total Score from Baseline to End of Study	The Gut Health Status Questionnaire (GHSQ) total score will be assessed at baseline and at the end of the study. The change from baseline will be analyzed.	Baseline to Week 8 (End of Study)
Change in Serum Immunoglobulin A (IgA) Concentration from Baseline to End of Study	Serum IgA concentration (mg/dL) will be measured at baseline and at study completion, and the change from baseline will be assessed.	Baseline to Week 8 (or end of study)
Change in Serum Immunoglobulin G (IgG) Concentration from Baseline to End of Study	Serum IgG concentration (mg/dL) will be measured at baseline and at study completion, and the change from baseline will be assessed.	Baseline to Week 8 (or end of study)
Change in Serum Immunoglobulin M (IgM) Concentration from Baseline to End of Study	Serum IgM concentration (mg/dL) will be measured at baseline and at study completion, and the change from baseline will be assessed.	Baseline to Week 8 (or end of study)
Change in Immune Status Questionnaire (ISQ) Total Score from Baseline to End of Study	The Immune Status Questionnaire (ISQ) total score will be assessed at baseline and at the end of the study. The change from baseline will be analyzed.	Baseline to Week 8 (End of 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 16, 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-25-072

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