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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
46
Experimental
Placebo
Advanced Gastro Care
Bangalore, Karnataka, India
• 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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 8 (End of Study)
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