Cure My Disease

Don't miss your cure!

 Log in / Sign up

Multiple fecal transplants may beat single dose for c. diff in colitis patients

NCT ID NCT06071312

Disease control Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether giving several fecal transplants (instead of just one) works better to clear repeat C. diff infections in people with ulcerative colitis. About 64 adults with active colitis and repeat C. diff will receive either one or multiple infusions of healthy donor stool. The goal is to see which approach more effectively eradicates the infection and improves gut health.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

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 75 years

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: * Age ≥18 years; * Active UC (partial Mayo score ≥2); * Relapsing infection of C. difficile; * Ability to express consent for inclusion in the study. * Indication, in the clinical practice setting, for fecal microbiota transplantation from a healthy donor for recurrent CDI Exclusion Criteria: * Age \< 18 years; * Other gastrointestinal infections, excluding C. difficile; * Known gastrointestinal diseases, other than UC, in active stage (e.g., infectious gastroenteritis, celiac disease, irritable bowel syndrome, chronic pancreatitis, bile acid diarrhea, etc.); * Previous colon surgery or skin ostomy packing; * Food allergies; * Current or recent (\<2 weeks) therapy with drugs that may alter the microbiota (e.g., systemic antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin), except antibiotics against C. difficile; * Heart failure or heart disease with FE ≤ 30 %; * Severe respiratory failure; * Psychiatric disorders; * Pregnancy and lactation; * Inability to provide informed consent.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Clostridium difficile are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis ulcerative colitis

As listed by the trial registrant

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

Clostridium difficile Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS

    RECRUITING

    Rome, 00168, Italy

More trials for these conditions

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