Multiple fecal transplants may beat single dose for c. diff in colitis patients
NCT ID NCT06071312
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Sep 2026
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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18 to 75 years
- 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.
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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.
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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 and phone numbers. 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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Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS
RECRUITINGRome, 00168, Italy
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