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New way to deliver c. diff treatment: through a colonoscopy

NCT ID NCT05831189

Disease control Sponsor: Ferring Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a treatment called RBX2660 (REBYOTA) for people with recurrent Clostridioides difficile infection. The treatment is made from healthy human stool bacteria and was given during a colonoscopy. The goal was to see if this delivery method is safe and works well. Forty-one adults took part, and the study also asked doctors and patients about their experience.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RBX2660 (REBYOTA), a live biotherapeutic product made from human stool bacteria
What this could lead to
If it works, this could offer a new way to deliver a proven treatment for recurrent C. diff infection, making it easier for patients to receive it during a routine colonoscopy.
What could go wrong
This is a small, single-arm trial with only 41 participants, so results may not apply to everyone. The treatment is already approved for other delivery methods, but colonoscopy delivery may have different risks or lower effectiveness.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

41 people

The number who actually took part.

Started

Apr 2023

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * have documented evidence of rCDI (≥1 recurrence after a primary CDI episode) * be undergoing antibiotic treatment for the qualifying rCDI episode that was diagnosed by a stool test for the presence of toxigenic C. difficile or C. difficile toxin * be eligible for FMT as judged by the investigator or current treatment guidelines for rCDI in the US * be a candidate for colonoscopy as judged by the investigator Exclusion Criteria: * Use or planned use of systemic antibiotics for an indication other than the qualifying rCDI episode. * Current uncontrolled chronic diarrhea not related to CDI. * Receipt of CDI vaccine or treatment with CDI monoclonal antibodies within the past 12 months before screening. * Evidence of active, severe, or fulminant colitis, diagnosis of toxic megacolon or have a current colostomy or ileostomy

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis diarrheal disease

As listed by the trial registrant

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

Clostridium difficile infection recurrence

Contacts and locations

Locations

  • Ferring Investigational Site

    North Little Rock, Arkansas, 72117, United States

  • Ferring Investigational Site

    Camarillo, California, 93012, United States

  • Ferring Investigational Site

    Hamden, Connecticut, 06518, United States

  • Ferring Investigational Site

    Idaho Falls, Idaho, 83404, United States

  • Ferring Investigational Site

    Gurnee, Illinois, 60031, United States

  • Ferring Investigational Site

    Shreveport, Louisiana, 71105, United States

  • Ferring Investigational Site

    Plymouth, Minnesota, 55446, United States

  • Ferring Investigational Site

    Rochester, Minnesota, 55905, United States

  • Ferring Investigational Site

    Cleveland, Ohio, 44195, United States

  • Ferring Investigational Site

    Oklahoma City, Oklahoma, 73102, United States

  • Ferring Investigational Site

    Burke, Virginia, 22015, United States

  • Ferring Investigational Site

    Madison, Wisconsin, 53705, United States

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