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

NCT03562741 | Recruiting

• 1 other identifier: H00003682
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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; Clostridium Difficile Infection Recurrence

Outcome Measures

Primary Outcomes (1)

• Clostridium Difficile (C. diff) resolution'

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

  12 months

Study Arms (1)

Fecal Microbiota Transplantation

EXPERIMENTAL

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

Procedure: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation PROCEDURE

Transplantation of Screened donor stool as part of Fecal Microbiota Transplantation

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \<16 years old
• patients with acute severe colonic dilation at risk for colonic perforation

Sponsors & Collaborators

• Krunal Patel: lead

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

RECRUITING

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Krunal Patel

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Foley

CONTACT

Anne.Foley@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 19, 2018
• Study Start: January 16, 2014
• Primary Completion (Estimated): January 16, 2028
• Study Completion (Estimated): January 16, 2029
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)