CSP #2004: MATCH - VA Cooperative Studies Program (CSP)
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VA Cooperative Studies Program (CSP)

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CSP #2004: MATCH

 Full title: CSP #2004: Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)

Investigator Access

What's Available

 




Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

Study Characteristics

Objectives

To assess the efficacy of fecal microbiota transplantation (FMT) for the prevention of subsequent recurrent Clostridium difficile infection (CDI), when administered after successful treatment of recurrent CDI with standard antimicrobial therapy.

Era of Service

All

Population

Veterans living anywhere in the US who are enrolled at a VA facility, aged 18 and older, who:

  • Have had one or more episodes of recurrent 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

Study Design

  • FMT: Half the participants will receive Fecal Microbiota Transplant (FMT) via oral capsule
  • Placebo: Half the participants will receive a placebo (sugar pill). The assignment is random, and the participant will not know what they received
  • All participants: All 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

Time Period

November 2018 – November 2023

Setting

National

N

390 participants

Response Rate

As of 2/28/21, a total of 1,926 patients were screened, 102 were eligible, and 102 underwent randomization.

Recruitment Method

The Minneapolis VA Medical Center centrally recruited patients nationwide who meet the eligibility criteria. Those providing written informed consent were enrolled in the study.  Due to the pandemic, recruitment has been conducted virtually using VA Video Connect (VVC) since September 2020. Priorly the study recruitment was in person.

Compensation

Participants will receive up to $250 total compensation ($100 at enrollment, $50 at approximately 8 weeks after enrollment, and $100 at approximately 6 months after enrollment).  Compensation will be made either via debit card or electronic funds transfer.

Data Collected

Data collection is still ongoing. 

Types of data being collected are:

  • screening, randomization
  • medical history, baseline medications, quality of life, recurrent evaluations post intervention, and Adverse Events (AE)/Serious Adverse Events (SAEs)

Data Collection Methods

  • Study Coordinators will enroll the patients at their home or place of residence or via VVC.
  • All follow up is via telephone

Funding Source

VA Cooperative Studies Program (CSP)

Contact

Ruth Anway, BA, RN, CCRP; Ruth.Anway@va.gov

Selected Publications

None

More Information