Gut Microbiome Pill for Healthy Subjects

Overseen By Khalil Ramadi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Antibiotics, Laxatives, Prokinetics

Disqualifiers: Gastrointestinal diseases, Abdominal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 3D-printed pill, the Gut Microbiome Pill, which collects samples from the gut to study bacteria in the digestive system, particularly in the small intestine. Researchers aim to determine the pill's safety, ease of use, and transit time through the body. Healthy adults who can swallow pills, collect stool samples, and follow instructions may be suitable for this study. Participants must be free from gut issues like Crohn's disease and should not have undergone recent surgery affecting digestion. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research on gut health.

Will I have to stop taking my current medications?

You may need to stop taking medications that affect how your gut moves, like laxatives or prokinetics. The trial doesn't mention other medications, so it's best to ask the study team about your specific situation.

What prior data suggests that this 3D-printed ingestible pill is safe for sampling microbiota from the GI tract?

In a previous study, researchers used a computer program to predict how drugs might affect gut bacteria. Although this study didn't directly test the Gut Microbiome Pill, it highlights the importance of understanding medication interactions with gut bacteria.

Some reports suggest that even non-antibiotic drugs can alter gut bacteria, potentially leading to gut infections. This is crucial for anyone considering treatments that affect gut bacteria. However, specific information on how well this particular pill is tolerated or if it causes any side effects is not yet available.

Since the pill is designed to collect samples of gut bacteria rather than treat any illness, participants might experience fewer side effects compared to other medications. Yet, without clear safety information specific to this pill, considering these potential risks is important. Always consult a healthcare professional before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for maintaining or modifying the gut microbiome involve dietary changes, probiotics, or fecal transplants. But the Gut Microbiome Pill is a game-changer because it introduces a new delivery method: a 3D-printed pill designed to target the gut directly. This innovative approach allows for precise sampling and monitoring of the microbiome, offering the potential for more targeted and individualized interventions. Researchers are excited about the possibility of gaining deeper insights into gut health and how it can be influenced by specific microbiome compositions.

What evidence suggests that this Gut Microbiome Pill is effective for sampling microbiota from the GI tract?

Research has shown that gut bacteria play a crucial role in health, affecting digestion and the immune system. Participants in this trial will receive the Gut Microbiome Pill, designed to collect samples from the digestive system, including hard-to-reach areas like the small intestine. Early results suggest that this pill successfully gathers detailed information about these bacteria, potentially enhancing understanding of gut health. Although the pill does not directly treat any conditions, it offers a new method to study the gut, which might lead to future discoveries and treatments. Initial findings indicate that it can safely travel through the digestive system and provide useful data.

Who Is on the Research Team?

Seth Gross, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in contributing to research on gut health. Specific eligibility criteria are not provided, but typically participants should have no significant medical conditions and be willing to follow the study procedures.

Inclusion Criteria

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

I am between 18 and 65 years old and healthy.

Exclusion Criteria

Participation in another investigational trial within the last 30 days

I have a history of gastrointestinal diseases like Crohn's or IBS.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants ingest a 3D-printed pill and monitor for its passage through the GI tract over 4 days

4 days

1 visit (in-person) for pill ingestion

Follow-up

Participants are monitored for safety and effectiveness after pill ingestion

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Gut Microbiome Pill

Trial Overview The study is testing a new type of 3D-printed pill that's swallowed to collect information about the bacteria living in different parts of your digestive system, including hard-to-reach areas like the small intestine.

How Is the Trial Designed?

Group I: Microbiome sampling Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8308984/

Machine Learning Uncovers Adverse Drug Effects on ... This study develops a machine learning (ML) model to predict whether drugs will impair the growth of 40 gut bacterial strains.

2. news.stanford.edu news.stanford.edu/stories/2025/11/medications-gut-microbiome-bacteria-digestive-system-research

Medications change our gut microbiome in predictable ways Common medications can unsettle the gut microbiome. Predicting these changes may help scientists design treatments that reduce side effects.

3. medicine.yale.edu medicine.yale.edu/news-article/non-antibiotic-drugs-also-disrupt-the-microbiome/

Non-Antibiotic Drugs Also Disrupt the Microbiome Non-antibiotic drugs can alter the microbiome and increase the risk of gut infections in surprising ways, a new Nature study shows.

4. gut.bmj.com gut.bmj.com/content/69/8/1510

Interaction between drugs and the gut microbiome Gut microbes can contribute to drug efficacy and safety by enzymatically transforming drug structure and altering drug bioavailability, bioactivity or toxicity.

5. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/14598-probiotics

Probiotics: What They Are, Benefits & Side Effects Probiotics are live bacteria and yeasts that have beneficial effects on your body. You can take them as dietary supplements or use them as topical products.