CompletedNot Applicable

Gut Microbiome Pill

United States10 participantsStarted 2026-01-21

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Number of participants who successfully passed the pill through the GI tract without causing any adverse effects such as GI discomfort, obstruction, or other complications

Timeframe: Pill retrieval (up to 4 days)

Number of samples that accurately represents bacterial populations in the small intestine, as well as the entire GI tract, when compared to stool samples

Timeframe: Pill retrieval (up to 4 days)

Trial details

NCT IDNCT07243756

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-20

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Number of participants who successfully passed the pill through the GI tract without causing any adverse effects such as GI discomfort, obstruction, or other complications

Timeframe: Pill retrieval (up to 4 days)

Number of samples that accurately represents bacterial populations in the small intestine, as well as the entire GI tract, when compared to stool samples

Timeframe: Pill retrieval (up to 4 days)