Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH) (MATCH)

  • STATUS
    Recruiting
  • End date
    Nov 15, 2023
  • participants needed
    390
  • sponsor
    VA Office of Research and Development
Updated on 7 February 2022
ileus
antibiotic therapy
antibiotics
diarrhea
microbiota
toxic megacolon

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.

Description

Clostridium difficile infection (CDI) is one of the most common nosocomial infections and is increasingly seen in non-hospitalized patients. Although more than 90% of patients have symptom resolution with a course of standard antimicrobial therapy, subsequent recurrence rates range from 15-30% (after the first CDI episode) to 40-50% (after the second and subsequent episodes). Fecal microbiota transplantation (FMT) has shown promise as an adjunct to standard antimicrobial therapy, reducing recurrence among FMT recipients to 15%.

The primary study goal is to assess the efficacy of FMT for the prevention of subsequent recurrent CDI, when administered after successful treatment of recurrent CDI with standard antimicrobial therapy. Secondary goals are to evaluate, the efficacy of FMT in terms of CDI severity, duration, the safety of FMT, and in the event of a positive study result, establish a mechanism for providing FMT within the VA system.

This study will enroll 390 participants. Participants will be randomized (1:1 ratio) to FMT or placebo, stratified by number of prior recurrent CDI episodes (1 versus >1). They will be assessed for symptoms of CDI, other study outcomes and any treatment-related adverse events at 2, 14, 28, 42, and 56 days, and month 3, 4, 5 and 6 after administration of the study treatment.

The primary outcome is recurrent CDI (definite or possible) or death within 56 days of randomization.

Definite recurrence is defined as any of the following: The new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis; Other clinical symptoms including ileus, toxic megacolon, or colectomy; PLUS Laboratory confirmation of C. difficile from a stool specimen by EIA toxin test. Possible recurrence is defined as the same clinical manifestations as above, but WITHOUT laboratory confirmation of C. difficile (stool test not sent, negative EIA toxin test result, or uninterpretable result).

Details
Condition Clostridium Difficile Infection
Treatment Placebo, Fecal Microbiota Therapy (FMT)
Clinical Study IdentifierNCT03005379
SponsorVA Office of Research and Development
Last Modified on7 February 2022

Eligibility

Yes No Not Sure

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 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
Ongoing antibiotic use other than those for the current episode of CDI
Prior FMT
Life expectancy of < 8 weeks
Anaphylactic food allergy
Active enrollment in another research study on antibiotics, probiotics, or FMT without investigators approval
Presence of an ileostomy or colostomy
HIV with CD4 count < 200 cells/L in prior 3 months
Decompensated cirrhosis
Bone marrow/peripheral blood stem cell transplant in the past year
Unlikely to follow study protocol
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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