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

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.

Study Overview

• Status: Recruiting
• Conditions: Clostridium Difficile Infection; Clostridium Difficile Infection Recurrence
• Intervention / Treatment: Procedure: Fecal Microbiota Transplantation

Detailed Description

Fecal microbiota transplantation (FMT) involves administering fecal material from a healthy individual into the gastrointestinal tract of the patient. This has been done in the past for recurrent colitis secondary to Clostridium difficile infection (CDI) using different methods such as through nasogastric tube, fecal retention enemas, and by colonoscopy. This method of treatment was introduced over 50 years ago with high success rates, although it has not been until recent that more case studies have been performed, with continued success rates of approximately 90%. Studies have found this therapy to be effective with resolution of symptoms in most patients, and have found it to be both cost effective and safe.

The purpose of this study is to use a standardized published protocol for fecal microbiota transplantation performed by colonoscopy and record the success rate and outcomes of FMT therapy for patients with recurrent CDI at the UMassMemorial Medical Center. In addition, the cost of this therapy will be compared to conventional antibiotic treatment. The reduction in hospitalizations will also be monitored compared with historical controls.

The hypothesis of this study is that FMT therapy will show resolution of infection in most patients with recurrent CDI, with an overall reduction in cost to the hospital for recurrent admissions for Clostridium difficile colitis as compared to historical controls. Historical controls will be defined as patients with recurrent positive Clostridium difficile stool samples treated in the traditional fashion with antibiotics.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Foley; Email: anne.foley@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • UMASS Memorial Medical Center
      • Contact: Anne Foley; Email: anne.foley@umassmed.edu
      • Principal Investigator: Krunal Patel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal Microbiota Transplantation; Subjects receive intervention of stool transplanted to the colon via colonoscopy.	Procedure: Fecal Microbiota Transplantation; Transplantation of Screened donor stool as part of Fecal Microbiota Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clostridium Difficile (C. diff) resolution'	Longterm resolution of C. diff associated diarrhea after Fecal Microbiota Transplantation (FMT) therapy	12 months

Collaborators and Investigators

• Sponsor: Krunal Patel
• Investigators: Principal Investigator: Krunal Patel, UMass Medical School

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2014
• Primary Completion (Anticipated): January 16, 2024
• Study Completion (Anticipated): January 16, 2025

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Recurrence; Clostridium Infections
• Other Study ID Numbers: H00003682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No