Study of the SIMBA Capsule to Collect Samples from the Small Intestine to Understand Gut Microbiome in Various Diseases

What this Trial Is About

Researchers are evaluating the SIMBA Capsule, a small, single-use, ingestible device designed to non-invasively collect samples from the small intestine using mechanical means. The study aims to understand how changes in the small intestinal microbiome and metabolites relate to gut symptoms across various diseases. This observational research seeks to identify potential biomarkers for functional gut disorders by comparing capsule-collected samples with stool microbial analysis and symptom questionnaires. Participants will swallow up to four SIMBA capsules on up to two separate occasions, providing small bowel fluid samples. Alongside this, stool samples will be collected simultaneously. No treatments are applied during the study, but participants will complete questionnaires about their medical history, lifestyle factors like diet and exercise, gastrointestinal symptoms, anxiety, and depression. The study includes groups with different gut-related conditions and healthy volunteers. During the study, participants will be assessed using metagenomic sequencing and metabolomics to analyze the bacterial composition and metabolites from the collected samples. Researchers will correlate these findings with gastrointestinal disease states and dietary intake. The study involves baseline assessments and pre-procedure evaluations, with the goal of better understanding symptom generation related to the small intestinal microbiome. Participation involves following study visits, sample collections, and completing questionnaires over the study duration.

Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis