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 range

18 Years – 65 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 65 Years

Sex

ALL

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.

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)