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.

This is a prospective, open-label pilot study designed to evaluate the safety and efficacy of a 3D-printed ingestible pill for microbiome sampling throughout the gastrointestinal (GI) tract, with a specific advantage in being able to sample bacteria from the small intestine. The study will enroll 10 participants, each ingesting the pill. Participants will use a metal detection device to identify the pill in their stool. Upon detection, participants will collect the stool sample and send it to the lab, where the pill will be extracted. Both the pill and stool samples will undergo 16S rRNA sequencing to profile the microbiome. The study will take approximately 4 days per participant

Inclusion Criteria:

1. Healthy adults aged 18-65.
2. Willing and able to provide informed consent.
3. Able and willing to comply with study procedures, including pill ingestion, stool collection, follow and record dietary instructions, and fill questionnaires.

Exclusion Criteria:

1. History of gastrointestinal diseases (e.g., Crohn's disease, irritable bowel syndrome, small intestinal bacterial overgrowth).
2. History of abdominal surgery that may impact gastrointestinal function (e.g., bowel resection, bariatric surgery).
3. Known allergies or intolerances to medical devices or ingestible capsules.
4. Recent antibiotic use (within 3 months) that may affect gut microbiome results.
5. Use of medications that alter GI motility such as laxatives or prokinetics.
6. Known anatomical abnormalities or strictures in the GI tract that increase the risk of obstruction.
7. 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.
8. Participation in another investigational trial within the last 30 days.

The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: seth.gross@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to seth.gross@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.