Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH) (NCT03005379) | Clinical Trial Compass
TerminatedPhase 2/3
Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)
Stopped: Study is terminated for futility per protocol-specified interim analysis and DMC recommendation.
United States153 participantsStarted 2018-11-15
Plain-language summary
The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. One or more episodes recurrent CDI (defined as \> 3 loose/watery stools/24h for 2 consecutive days with CDI treatment, and not explained by another diagnosis plus laboratory confirmation of C. difficile; or ileus, or toxic megacolon plus laboratory confirmation of C. difficile, occurring within 90 days of a prior CDI episode with similar symptoms and laboratory confirmation)
✓. Resolution or improvement of symptoms from most recent CDI episode, defined as no longer meeting the clinical definition for CDI for a 48 hour period during treatment, including not meeting the definition again after an initial improvement
✓. Within the enrollment window: 2 days after completion of antimicrobial therapy for CDI (to allow for a washout period) to 14 days after completion of therapy or 30 days after the onset of CDI whichever is later.
✓. Age 18 years
✓. Enrolled in a Veterans Health Administration (VHA) facility
✓. Able and willing to provide informed consent
Exclusion criteria
✕. Unlikely to swallow capsules
✕. Pregnancy, planning to be pregnant, or breastfeeding
✕. Receipt of cytotoxic chemotherapy, intravenous or subcutaneous immune globulin, or confirmed neutropenia (absolute neutrophil count of \< 1,000 cells/ L) within the past 3 months
✕. Inflammatory bowel disease or other chronic diarrheal disease/fecal incontinence predating CDI
What they're measuring
1
Possible or Definite Recurrent Clostridium Difficile Infection (CDI), or Death