Gut Microbiome Pill
A Pilot Proof of Concept Study, Single-center, Open-label Study to Assess the Safety and Efficacy of an Ingestible Pill for Gut Microbiome Sampling in Healthy Humans
NYU Langone Health
10 participants
Jan 21, 2026
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety and efficacy of a 3D-printed ingestible pill designed to sample microbiota from the GI tract, focusing on the ability to collect data also from the small intestine. The study also aims to assess ease of use and transit time.
Eligibility
Inclusion Criteria3
- Healthy adults aged 18-65.
- Willing and able to provide informed consent.
- Able and willing to comply with study procedures, including pill ingestion, stool collection, follow and record dietary instructions, and fill questionnaires.
Exclusion Criteria8
- History of gastrointestinal diseases (e.g., Crohn's disease, irritable bowel syndrome, small intestinal bacterial overgrowth).
- History of abdominal surgery that may impact gastrointestinal function (e.g., bowel resection, bariatric surgery).
- Known allergies or intolerances to medical devices or ingestible capsules.
- Recent antibiotic use (within 3 months) that may affect gut microbiome results.
- Use of medications that alter GI motility such as laxatives or prokinetics.
- Known anatomical abnormalities or strictures in the GI tract that increase the risk of obstruction.
- Pregnant, planning pregnancy or breastfeeding, since pregnancy and breastfeeding affect the microbiome, Exclusion of pregnancy will be confirmed by the date of the last menstrual period.
- Participation in another investigational trial within the last 30 days.
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Interventions
The pill consists of a microporous architecture specifically designed to trap bacteria. The pill contains a ferrous (iron) ball for detection with a metal detection device and passes naturally and passively through the GI tract.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07243756