VA Cooperative Studies Program (CSP)
CSP #2004 Microbiota or Placebo after Antimicrobial Therapy for Recurrent C. difficile at Home
Overview
CSP #2004 study is a national voluntary research study that is sponsored by the VA’s Office of Research and Development. It is also known as MATCH, which stands for “Microbiota or Placebo after Antimicrobial Therapy for Recurrent C. difficile at Home.” The goal of MATCH is to assess whether fecal microbiota transplant (FMT), also known as ‘stool transplant’ is effective at preventing recurrent C. difficile infection (CDI).
Background
Clostridium difficile infection is one of the most common hospital-acquired infections and is increasingly common in patients who have not been in the hospital. Although more than 90% of patients get better with a course of standard antimicrobial therapy, recurrence is common. Recurrence rates range from 15-30% (after the first CDI episode) to 40-50% (after the second and subsequent episodes). FMT has shown promise when given after standard antimicrobial therapy in smaller studies, substantially reducing CDI recurrence among FMT recipients. FMT can now be administered by swallowing special capsules, which provides an opportunity to deliver FMT in a convenient method without the need for a medical procedure like a colonoscopy. Because the VA, like most US hospitals, has a high burden of recurrent CDI, there has been considerable interest in FMT from both providers and patients. Currently, some VA facilities provide FMT, others refer patients to community-based providers, and others do not offer FMT. Because of the lack large clinical trials showing that FMT is effective, there is regulatory uncertainty. The Food and Drug Administration currently requires an Investigational New Drug application (IND) for research involving FMT, and other restrictions for non-research use, including obtaining written informed consent.
Status of the Project
Enrollment for CSP #2004 has stopped. Results will be published in the near future. The study team is grateful for the support of all participants and referring clinicians.
Who Can Participate?
Veterans enrolled at a VA facility, age 18 and older, who have had one or more episodes of recurrent C. difficile infection; have had resolution or improvement of symptoms from the most recent CDI episode; enroll within 2 to 14 days after completion of antimicrobial therapy or 30 days after the onset of CDI (whichever is later); and are able to provide informed consent can participate. Veterans living anywhere in the United States are eligible to participate. The Study Coordinators will enroll the patients at their home or place of residence. All follow up is via telephone.
What Does Participation Involve?
- FMT: Half the study participants will receive Fecal Microbiota Transplant (FMT) via oral capsule.
- Placebo: Half the study participants will receive a placebo (sugar pill). The assignment is random and the participant will not know what they received.
- All Participants: All study participants will be followed via phone at days 2, 14, 28, 42, and 56 after capsule administration, and once a month thereafter until month 6.
Human Research Protections
The MATCH protocol has been approved by the Minneapolis VA Institutional Review Board (IRB) and VA Cooperative Studies Scientific Evaluation Committee (CSSEC), and has been reviewed by the U.S. Food and Drug Administration (FDA). The study is monitored by the VA Cooperative Studies Program, the Minneapolis VA IRB and an independent Data Monitoring Committee.
Leadership
MATCH Study's Co-Chairs are:
Dimitri Drekonja, MD, MS, an infectious disease specialist at the Minneapolis VA Medical Center, and
Aasma Shaukat, MD, MPH, a gastroenterology specialist at the Minneapolis VA Medical Center.
Sponsorship
This project is sponsored by the Cooperative Studies Program (CSP) of the Department of Veterans Affairs Office of Research and Development, Washington, DC.
For More Information
See registration in Clinicaltrials.gov (https://clinicaltrials.gov): NCT03005379
If you have any questions, please contact MATCH National Study Coordinator Ruth Anway, BA, RN, CCRP, at ruth.anway@va.gov, or 612-467-2860.
From Left to Right-
Andrew Reinink, MD, Site Investigator
Ruth Anway, BA, RN, CCRP, National Study Coordinator
John Belew, RN, Study Coordinator
From Left to Right-
Ruth Anway, BA, RN, CCRP, National Study Coordinator
Andrew Reinink, MD, Site Investigator
Alex Pretti, Study Support
Sean Nugent, Study Support
John Belew, RN, Study Coordinator
Updated December 2018
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