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Gut bacteria may change how drugs work in your body

NCT ID NCT05065671

Knowledge-focused Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how bacteria in the gut can change the way the body processes certain drugs. 17 healthy adults took specific medicines, and researchers measured drug levels in their blood. The goal was to better understand why people respond differently to the same drug, which could lead to more personalized treatments in the future.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

17 people

The number who actually took part.

Started

Feb 2022

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 to 65 years of age * Body mass index between 18.5 - 29.9 kg/m2 Exclusion Criteria * Estimated creatinine clearance \< 50 mL/min * Liver impairment (liver enzymes \> 2 times upper limit) * Antibiotics in the past 3 months * History of gastrointestinal disease * History of autoimmune disorder * Chronic viral infection * Smoker * Alcohol intake (defined as having up to 1 drink per day for women and up to 2 drinks per day for men) * Use of immune modulating medications * Diabetes mellitus * Any history or contraindication to the study medications * Additional exclusion criteria will be based on the FDA approved prescribing information for selected drugs (i.e., contraindications)

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Conditions

The condition(s) this trial relates to.

infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Microbial colonization

Contacts and locations

Locations

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.