RecruitingNCT05633706

Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

Evaluation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule for Small Intestinal Dysbiosis

Sponsor

Nimble Science Ltd.

Enrollment

300 participants

Start Date

Jan 9, 2023

Study Type

OBSERVATIONAL

Conditions

Healthy Celiac Disease Crohn Disease Ulcerative Colitis Type 2 Diabetes Irritable Bowel Syndrome Functional Dyspepsia

Summary

The SIMBA Capsule is a small, single-use, ingestible capsule that allows for the non-invasive sampling of small bowel contents using purely mechanical means. The study will compare the microbial and metabolomics analysis from the sample collected with the capsule series, to same-participant symptom questionnaires and stool microbial analysis.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a new swallowable capsule called SIMBA that collects fluid samples from the small intestine to check for bacterial imbalances (dysbiosis), which may play a role in gut diseases like Crohn's disease, IBS, or celiac disease. The goal is to see if this capsule is a reliable diagnostic tool. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with a gut condition (celiac disease, Crohn's disease, ulcerative colitis, IBS, or functional dyspepsia) OR you are a healthy volunteer without any of these conditions - You are willing to swallow the capsule **You may NOT be eligible if...** - You have type 2 diabetes (unless you are in a specific study arm) - You cannot swallow capsules - You have conditions that make capsule endoscopy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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