Worcester, Massachusetts 01655

  • Clostridium Difficile Infection

Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

H00003682


NCT ID:

NCT03562741


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

16 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Massachusetts, Worcester


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

500


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Krunal Patel
Principal Investigator
UMass Medical School
Primary Contact:Anne Foley
IBDClinicalTrials@umassmed.edu

Study Dates

Start Date:January 16, 2014
Completion Date:January 16, 2023
Completion Type:Anticipated
Primary Completion Date:January 16, 2022
Primary Completion Type:Anticipated
Verification Date:June 2020
Last Changed Date:June 22, 2020
First Received Date:June 7, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Clostridium Difficile (C. diff) resolution`
Time Frame:12 months
Safety Issues:False
Description:Longterm resolution of C. diff associated diarrhea after Fecal Microbiota Transplantation (FMT) therapy

Study Interventions

Intervention Type:Procedure
Name:Fecal Microbiota Transplantation
Description:Transplantation of Screened donor stool as part of Fecal Microbiota Transplantation
Arm Name:Fecal Microbiota Transplantation

Study Arms

Study Arm Type:Experimental
Arm Name:Fecal Microbiota Transplantation
Description:Subjects receive intervention of stool transplanted to the colon via colonoscopy.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Krunal Patel

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 25, 2021

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