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
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jan 2026
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
November 24, 2025
CompletedStudy Start
First participant enrolled
January 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2026
CompletedMay 4, 2026
May 1, 2026
3 months
November 17, 2025
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Participants will be asked to report any subsequent events to the study team. Adverse Events (AEs) will be collected through solicited questions (e.g., "Have you experienced any discomfort after ingesting the pill?") and unsolicited reports from participants. All events will be categorized, and severity will be graded.
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
Outcome is evaluated using 16S ribosomal RNA (rRNA) sequencing to compare microbial diversity and the presence of specific bacterial taxa between the pill and stool samples.
Pill retrieval (up to 4 days)
Secondary Outcomes (1)
Time taken for the pill to pass through the GI tract
From ingestion until pill retrieval (up to 4 days)
Study Arms (1)
Microbiome sampling
EXPERIMENTALParticipants will ingest one single 3D-printed pill and monitor for the pill in their stool over the next 4 days using a metal detection device. Upon detection participants will collect a sample of the stool and the pill.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Participation in another investigational trial within the last 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Seth Gross, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2025
First Posted
November 24, 2025
Study Start
January 21, 2026
Primary Completion
April 20, 2026
Study Completion
April 20, 2026
Last Updated
May 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- 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.
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.