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Can a national registry unlock the safety secrets of fecal transplants?

NCT ID NCT06311006

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study is building a large national registry to track the safety and effectiveness of fecal microbiota transplantation (FMT) in patients with Clostridium difficile infections. It will follow adult patients receiving FMT as part of their routine care, as well as stool donors, to monitor for complications and disease recurrence. The goal is to gather real-world data that can help evaluate and improve the safety of this treatment.

What this could mean

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

Active substance
Fecal microbiota transplantation (FMT)
What this could lead to
If successful, this registry could provide crucial safety data on FMT, potentially supporting its wider use and improving guidelines for treating recurrent C. difficile infections.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. It relies on routine care data, which may be incomplete or vary across centers.

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.

Participants

About 305 people

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

Started

Jan 2021

Expected to finish

Jan 2029

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.

Who is studied

Patient with an indication for fecal microbiota transplantation as part of the treatment for Clostridium difficile infection

Ages

18 years and older

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: Patients : * Adult patient with an indication for FMT for CDI (severe refractory CDI, recurrent CDI); * Informed written consent Donors: * Adult (18 years or older) * Informed Written consent Exclusion Criteria: * insufficient level of understanding of written and spoken French language

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis Clostridium infectious disease

As listed by the trial registrant

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

Clostridium difficile infections

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

  • Gastroenterology Department of Saint Antoine Hospital

    RECRUITING

    Paris, 75012, France

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