Assessing Changes in the Gut Microbiome of Non-Gastrointestinal Disordered Subjects Before and After Oral Prebiotic Supplementation Using the SIMBA Capsule

This is a randomized, double‐blind, placebo‐controlled, parallel‐group clinical study.The primary objective is to assess the changes in the small intestinal (SI) metagenomicprofile of healthy participants without any known gastrointestinal disorders frombaseline to endpoint in response to the prebiotic intervention (FiberSmart). The studypopulation are adults (n=30) who will ingest either the FiberSmart or a matched Placebodaily for 21 days. Both products will be referred to as the Investigational Product (IP)in the study procedures section. While prebiotics are widely used for gut health, theirspecific impact on the small intestinal ecosystem remains largely uncharacterizedcompared to the large intestine. Understanding their impact on the upper GI tract canlead to new insights into their mechanisms of action. Given the critical role of thesmall intestine in metabolism and immunity, the study utilizes the SIMBA capsule tomeasure novel changes in the small intestine along with traditional measurements fromstool samples.