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Poop pills aim to break the cycle of recurrent c. diff

NCT ID NCT07458984

Disease control Sponsor: Helsinki University Central Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 taking capsules made from healthy donor stool (fecal microbiota transplantation, or FMT) can prevent another bout of C. diff infection in people who have had it come back at least twice. 76 adults will receive either active FMT capsules or placebo, and researchers will track who gets diarrhea and a positive C. diff test within 12 weeks. The goal is to see if this simple pill approach works better than a dummy 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 (healthy donor stool) in oral capsules
What this could lead to
If it works, this could offer a simple, pill-based way to prevent recurrent C. diff infections without needing antibiotics or hospital procedures.
What could go wrong
This is a phase 3 trial, but it's still relatively small (76 people). The placebo group may also show improvement, and long-term safety or effectiveness beyond 12 weeks isn't yet known.

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

About 76 people

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

Started

Apr 2026

Expected to finish

Dec 2030

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 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: * At least twice recurrent CDI\* * Patient has had CDI-related diarrhea during infections (3 or more Bristol Stool Form Scale type 6-7 stools) * Other causes of diarrhea have been excluded based on clinical data * Age over 18 years * Remission of symptoms during antibiotic course (metronidazole, vancomycin or fidaxomicin) * No other antibiotic courses * Able to sign the consent form or accept it electronically via Suomi.fi identification * definition of recurrent CDI: CDI-compatible symptoms and a positive stool test Clostridioides difficile nucleic acid test within 12 weeks of the previous infection Exclusion Criteria: * Pregnancy * Continuous need for antibiotic treatment * Previous anaphylactic reactions to any food * Gastroparesis * Life-threatening fulminant CDI * Life expectancy less than 1 year * Inability to sign a consent form for the study

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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.

Clostridioides difficile infection recurrence FMT

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

  • Helsinki University Hospital

    RECRUITING

    Helsinki, Uusimaa, 00290, Finland

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