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

NCT07377942 | Enrolling By Invitation

• 1 other identifier: BSP-25-072
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gut Health and Immunomodulatory effect

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (5)

• Change in Gut Health Status Questionnaire (GHSQ) Total Score from Baseline to End of Study

  Baseline to Week 8 (End of Study)

• Change in Serum Immunoglobulin A (IgA) Concentration from Baseline to End of Study

  Baseline to Week 8 (or end of study)

• Change in Serum Immunoglobulin G (IgG) Concentration from Baseline to End of Study

  Baseline to Week 8 (or end of study)

• Change in Serum Immunoglobulin M (IgM) Concentration from Baseline to End of Study

  Baseline to Week 8 (or end of study)

• Change in Immune Status Questionnaire (ISQ) Total Score from Baseline to End of Study

  Baseline to Week 8 (End of Study)

Study Arms (2)

Probiotics

EXPERIMENTAL

Bacillus subtilis

Dietary Supplement: Probiotics (Bacillus Subtilis)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Probiotics (Bacillus Subtilis) DIETARY_SUPPLEMENT

Experimental

Probiotics

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Willing to participate voluntarily and provide written informed consent.

You may not qualify if:

• Women who are pregnant or lactating.
• Subjects who are taking Antibiotic treatment.
• Subjects suffering from Gastrointestinal disease.
• Subjects suffering from Diabetes.
• Subjects suffering from Chronic/iatrogenic Immunodeficiency.
• Subjects suffering from Abnormal blood pressure.
• Subjects who are allergic to ingredients of the study Product.
• Subjects who are Smoker or alcoholic.
• Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months.
• Women who are pregnant, breastfeeding, or planning to become pregnant.
• Daily use of supplements that contain probiotics or prebiotics within 30 days prior to screening or during study.
• 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.
• Any surgical treatment within the previous three months or planned during the study.
• Any subject, in the principal investigator's opinion, not considered suitable for enrolment.

Sponsors & Collaborators

• Bioagile Therapeutics Pvt. Ltd.: lead

Study Sites (1)

Advanced Gastro Care

Bangalore, Karnataka, 560018, India

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Parag Saudagar

  S K Biobiz Private Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 30, 2026
• Study Start: September 16, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): May 10, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)