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Patients Eligible for Trials of Microbe-Based Therapeutics Do Not Represent the Population With Recurrent

Colleen R Kelly1, Monika Fischer2, Ari Grinspan3

  • 1Division of Gastroenterology, Brown University, Providence, Rhode Island.

Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association
|June 30, 2019
PubMed
Abstract

Insights

Most patients with recurrent Clostridioides difficile infection (CDI) are ineligible or unwilling to join clinical trials for microbe-based therapies. This limits the generalizability of trial findings to the broader CDI patient population.

Area of Science:

  • Microbiology
  • Infectious Diseases
  • Clinical Trials

Background:

  • Clostridioides difficile infection (CDI) is a significant healthcare challenge.
  • Microbe-based therapeutics and fecal microbiota transplantation (FMT) are effective treatments for recurrent CDI.
  • Industry-funded clinical trials for these therapies have strict eligibility criteria.

Purpose of the Study:

  • To analyze the eligibility and willingness of patients with recurrent CDI to participate in randomized controlled trials (RCTs) of microbe-based therapeutic agents.
  • To assess potential discrepancies between clinical trial populations and the general CDI patient population.

Main Methods:

  • A retrospective study was conducted involving 199 patients with CDI referred to four tertiary referral centers.
  • Data on eligibility for FMT and enrollment in RCTs were collected between August 2018 and January 2019.

Main Results:

  • Of 130 patients eligible for FMT, 98 (75%) were ineligible for RCT participation.
  • An additional 16 patients (17%) were eligible but refused to enroll in RCTs.
  • Common exclusion reasons included immune compromise and inflammatory bowel diseases.

Conclusions:

  • A significant proportion of CDI patients suitable for FMT are unable to participate in RCTs for microbe-based therapies.
  • Trial participants may not accurately represent the broader CDI patient population.
  • Findings highlight challenges in recruiting representative cohorts for CDI therapeutic trials.
Keywords:
BacteriaEncapsulated FormulationMicrobiomeStool Banks

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