Advanced Gastro Care
Bangalore, Karnataka, 560018, India
NCT Number: NCT07377942
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.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
Bangalore, Karnataka, 560018, India
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Experimental
Placebo
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.
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.
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.
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.
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.
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.
Bioagile Therapeutics Pvt. Ltd.
Industry
A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Gut Health and Immunomodulatory Effects of Bacillus Subtilis-based Product in Healthy Adults
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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