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. 2023 Apr 25;2023(4):CD013871. doi: 10.1002/14651858.CD013871.pub2

NCT03005379.

Study name Microbiota or placebo after antimicrobial therapy for recurrent C. difficile at home (MATCH)
Methods Randomized clinical trial
Participants Inclusion criteria

  1. ≥ 1 episodes recurrent CDI (defined as > 3 loose/watery stools/24 hours 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).

  2. 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.

  3. 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.

  4. Age 18 years

  5. Enrolled in a VHA facility

  6. Able and willing to provide informed consent


Exclusion criteria

  1. Unlikely to swallow capsules

  2. Pregnant, planning to be pregnant, or breastfeeding

  3. Receipt of cytotoxic chemotherapy, intravenous or subcutaneous immune globulin, or confirmed neutropenia (ANC < 1000 cells/L) within the past 3 months

  4. Inflammatory bowel disease or other chronic diarrheal disease/fecal incontinence predating CDI

  5. Ongoing antibiotic use other than those for the current episode of CDI

  6. Prior FMT

  7. Life expectancy < 8 weeks

  8. Anaphylactic food allergy

  9. Active enrollment in another research study on antibiotics, probiotics, or FMT without investigators approval

  10. Presence of an ileostomy or colostomy

  11. HIV with CD4 count < 200 cells/µL in prior 3 months

  12. Decompensated cirrhosis

  13. Bone marrow/peripheral blood stem cell transplant in the past year

  14. Unlikely to follow study protocol
Interventions Intervention
Oral capsule‐delivered FMT
Comparison
Oral capsule‐delivered placebo
Outcomes Primary outcomes
Recurrent CDI (definite or probable) or death within 56 days of randomization. Definite recurrence defined as any of the following: new onset of > 3 loose or watery stools in 24 hours for 2 consecutive days; other clinical symptoms including ileus, toxic mega colon, or colectomy plus laboratory confirmation of C difficile from a stool specimen. Probable recurrence defined as the same clinical manifestations as above, but without laboratory confirmation of C difficile (stool test not sent, negative result, or uninterpretable result)
Secondary outcomes

  1. rCDI (definite or possible), or death (time frame: within 6 months of randomization)

  2. Quality of life (time frame: 56 days from randomization)

  3. Number of CDI recurrences (time frame: within 6 months of randomization)

  4. Diarrhea that is negative for C difficile by EIA toxin test and PCR (time frame: within 56 days of randomization)

  5. Multiple related symptoms (non‐diarrheal manifestations of CDI such as abdominal pain, urgency, and fecal incontinence) (time frame: within 6 months of randomization)

  6. Definite recurrent CDI (time frame: within 56 days of randomization)

  7. Possible recurrent CDI (time frame: within 56 days of randomization)

  8. Death (time frame: within 56 days of randomization)

  9. Diarrhea that is negative for C difficile by EIA toxin testing but positive by PCR (time frame: within 56 days of randomization)
Starting date 15 November 2018
Contact information Dimitri M Drekonja MD, study chair, Minneapolis VA Health Care System, Minneapolis, Minnesota
Notes Estimated enrollment: 390