Effects of Bacillus Coagulans-Based Probiotic on Gut Health and Immune Response in Healthy Adults
This study investigates how a Bacillus Coagulans-based probiotic affects gut health and immune response in healthy adults.
Probiotic (Bacillus Coagulans)
+ Placebo
Other Study
Summary
Study start date: September 10, 2025
Actual date on which the first participant was enrolled.This clinical trial is a randomized, double-blind, placebo-controlled study that aims to evaluate the effects of a probiotic product based on Bacillus coagulans on gut health and immune responses in healthy adults. The study seeks to generate evidence on the role of Bacillus coagulans in maintaining gut balance and supporting immune function under normal conditions. The trial is important as it can help understand how probiotics might benefit overall health and well-being in healthy individuals. Participants in this study will be instructed to consume the assigned probiotic or placebo product twice daily, after meals, for the duration of the study. The effects of the probiotic will be assessed through various measures, including changes in fecal calprotectin levels, a well-established biomarker of gut inflammation. Additionally, selected immune and inflammatory markers, such as immunoglobulins, will be evaluated to understand the immunomodulatory effects. Participants will also report their gut health and immune status using validated questionnaires. Safety and tolerability of the probiotic product will be monitored throughout the study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.46 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location