Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
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|ClinicalTrials.gov Identifier: NCT03562741|
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : December 20, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection Recurrence Clostridium Difficile Infection||Procedure: Fecal Microbiota Transplantation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile|
|Actual Study Start Date :||January 16, 2014|
|Estimated Primary Completion Date :||January 16, 2024|
|Estimated Study Completion Date :||January 16, 2025|
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
- Clostridium Difficile (C. diff) resolution' [ Time Frame: 12 months ]Longterm resolution of C. diff associated diarrhea after Fecal Microbiota Transplantation (FMT) therapy
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|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Age <16 years old
- patients with acute severe colonic dilation at risk for colonic perforation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562741
|Contact: Anne Foley||Anne.Foley@umassmed.edu|
|United States, Massachusetts|
|UMass Memorial Medical Center||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Anne Foley Anne.Foley@umassmed.edu|
|Principal Investigator: Krunal Patel, MD|
|Principal Investigator:||Krunal Patel||UMass Medical School|
|Responsible Party:||Krunal Patel, Principal Investigator, University of Massachusetts, Worcester|
|Other Study ID Numbers:||
|First Posted:||June 19, 2018 Key Record Dates|
|Last Update Posted:||December 20, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Gram-Positive Bacterial Infections
Bacterial Infections and Mycoses