Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile

ConditionsClostridium Difficile Infection Recurrence Clostridium Difficile Infection

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age16+

SponsorKrunal Patel

About this trial

The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <16 years old

patients with acute severe colonic dilation at risk for colonic perforation

Trial design

Design model

Single group

Treatments tested in this trial

Fecal Microbiota Transplantation
Procedure/Surgery
Transplantation of Screened donor stool as part of Fecal Microbiota Transplantation

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: Fecal Microbiota TransplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Clostridium Difficile (C. diff) resolution'

Longterm resolution of C. diff associated diarrhea after Fecal Microbiota Transplantation (FMT) therapy

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Krunal Patel

Lead sponsor

University of Massachusetts, Worcester

Sponsor institution

Source ClinicalTrials.gov

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