Gut Microbiome Pill

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-21

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Novel Supplement-based Therapy for the Treatment of Small Intestinal Bacterial Overgrowth

NCT03420976

Small Intestinal Bacterial Overgrowth

WITHDRAWN EARLY_PHASE1

Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics

NCT03523936

Changes in the Gut Microbiota During an Antibiotic Treatment

UNKNOWN NA

A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Gastrointestinal Microbiome

NCT01724736

Pre Diabetic

COMPLETED NA

A Study to Investigate the Safety and Efficacy of a Probiotic on Gastrointestinal Health in Healthy Adults

NCT04223388

Gastrointestinal Health Healthy

UNKNOWN NA

The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults

NCT03611400

Intestinal Barrier Function

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Microbiome sampling

Participants 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.

Group Type EXPERIMENTAL

3D-printed ingestible pill

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

3D-printed ingestible pill

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes