Recruiting

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

Sponsor:

Krunal Patel

Code:

NCT03562741

Conditions

Clostridium Difficile Infection Recurrence

Clostridium Difficile Infection

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Fecal Microbiota Transplantation

Study Details

Brief summary:

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.

Conditions

Clostridium Difficile Infection Recurrence

Clostridium Difficile Infection

Study ID

NCT03562741

Start date

Jan 16, 2014

Status verified date

Feb, 2026

Completion date

Jan 16, 2029

Anticipated

Primary completion date

Jan 16, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fecal Microbiota Transplantation

Subjects receive intervention of stool transplanted to the colon via colonoscopy.

Interventions

Fecal Microbiota Transplantation

Transplantation of Screened donor stool as part of Fecal Microbiota Transplantation

Primary outcome measure

Clostridium Difficile (C. diff) resolution' [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Anne Foley

Anne.Foley@umassmed.edu

Locations

UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Anne Foley

Anne.Foley@umassmed.edu

Principal Investigator:

Krunal Patel, MD

More Information

Sponsor

Krunal Patel

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Krunal Patel on 2026-02-20.