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Enrolling by Invitation

NCT Number: NCT07377942

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

Enrolling by Invitation

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Gastro Care

Bangalore, Karnataka, 560018, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Probiotics (Bacillus Subtilis)

Dietary Supplement

Experimental

Placebo

Other

Placebo

Primary outcomes

  1. • Change in fecal calprotectin levels from baseline to the end of the study.

    Time frame: Baseline to Week 8 (or end of 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.

Secondary outcomes

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

    Time frame: Baseline to Week 8 (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.

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

    Time frame: Baseline to Week 8 (or 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.

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

    Time frame: Baseline to Week 8 (or 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.

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

    Time frame: Baseline to Week 8 (or 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.

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

    Time frame: Baseline to Week 8 (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.

Sponsors and collaborators

Lead sponsor

Bioagile Therapeutics Pvt. Ltd.

Industry

Registry information

Official study title

A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Gut Health and Immunomodulatory Effects of Bacillus Subtilis-based Product in Healthy Adults

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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