An interventional study of Probiotic (Bacillus Coagulans) and Placebo in Healthy Subjects (HS), sponsored by Bioagile Therapeutics Pvt. Ltd.. Enrolling by invitation at 1 site in India. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Bioagile Therapeutics Pvt. Ltd. · Not applicable, Interventional, and Other
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.
Bioagile Therapeutics Pvt. Ltd. is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Probiotic
Dietary Supplement: Probiotic (Bacillus Coagulans)
Placebo
Other: Placebo
Experimental
Placebo
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.
Time frame: Baseline to Week 8 (or end of study)]
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
Time frame: 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
Time frame: 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
Time frame: Baseline to week 8 (End of the Study)
Plan to share: No
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Bioagile Therapeutics Pvt. Ltd.