Poop pills? no, stool transplants aim to cure recurrent c. diff
NCT ID NCT03562741
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether transplanting stool from a healthy donor into the colon can prevent recurrent C. diff infections. The procedure, done via colonoscopy, aims to restore good bacteria that keep C. diff in check. Researchers are tracking 500 people to see if this stops diarrhea from coming back.
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 (stool from a healthy donor)
- What this could lead to
- If successful, this could offer a reliable way to prevent repeat C. diff infections without relying on antibiotics.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less conclusive. Risks include infection from donor stool or procedure complications.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2014
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy. * Failed standard therapy with oral metronidazole and/or oral vancomycin * One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity Exclusion criteria: * Age \<16 years old * patients with acute severe colonic dilation at risk for colonic perforation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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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
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UMass Memorial Medical Center
RECRUITINGWorcester, Massachusetts, 01655, United States
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Other studies related to the condition(s) this trial covers.
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- Poop pills? fecal transplants show promise for gut infections
- New pill aims to break the cycle of repeat c. diff infections