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Fecal Microbiota Transplantation for C Diff Infection

This study is testing Fecal Microbiota Transplantation (FMT) for people with Clostridium difficile infection (CDI) that keeps coming back or hasn't responded to other treatments. FMT involves placing stool from a healthy donor into your bowel during a colonoscopy. The idea is that good bacteria from the donor stool can fight off C. difficile by making substances that kill it and by preventing its toxins (poisons) from attaching to your colon. The study aims to see if FMT can prevent CDI from returning, with success measured at 8 weeks. You might be able to join if you are at least 18 years old and have had at least three episodes of mild-to-moderate CDI that haven't improved with standard antibiotic treatments.

Study design
This is an interventional study planning to enroll 100 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to see if their CDI recurs at 8 weeks.

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NCT01905709

Fecal Microbiota Transplantation for C Diff Infection

Recruiting
NAAges 18+InterventionalTreatment
Englewood Hospital and Medical Center
~100 participants
Updated 2025-04-13 on ClinicalTrials.gov
What's tested:Human fecal matter

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CDI recurrence
Measured over 8 weeks

Conditions

Clostridium Difficile Infection

Explore related trials

Clostridium difficile Infection

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Marc Fiorillo, MD · PRINCIPAL_INVESTIGATOR · Englewood Hospital and Medical Center

Who to contact

Marc Fiorillo, MD
[email protected]
201-945-6564
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Eligibility criteria

Inclusion

At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g., rifaximin, nitazoxanide, fidaxomicin). OR
At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity. OR
Moderate CDI not responding to standard therapy (vancomycin) for at least a week. OR
Severe C. difficile infection with toxic megacolon, not responding to standard therapy or the use of IVIg. 3. Subject is willing and able to provide informed consent. 4. If a female of childbearing potential, subject has agreed to use an acceptable form of birth control for up to 4 weeks after FMT treatment.

What this trial measures

  • CDI recurrence8 weeks

    Number of patients who did/did not experience relapse in the 8 weeks post FMT