The Protocol


Solid organ transplantation (SOT) is an important treatment for end stage organ failure of many kinds. However, due to immunosuppression, frequent antibiotic use and medical procedures all of which cause disruption of the normal gut bacterial community, SOT is associated with a high rate of C. difficile infection (CDI) and recurrent CDI. Fecal microbiota transplantation (FMT) may reduce recurrence by replenishing normal gut bacterial communities. We propose a clinical trial to determine the effect of FMT on CDI recurrence in SOT recipients with C. difficile infection compared with usual care.

Full Title Fecal Microbiota Transplantation (FMT) for C. difficile Infection (CDI) in Solid Organ Transplant Recipients
Short Title RECOVER
Protocol Number 2018-1056 NCT03617445
IND Number 27262
IND Sponsor Nasia Safdar, MD, PhD
Funding Source U01AI125053, National Institute of Allergy and Infectious Diseases (NIAID)
Phase Phase II
Précis A multisite, randomized, double-blind, doubly placebo-controlled phase II trial comparing the safety and efficacy of fecal microbiota transplant (FMT) versus oral vancomycin for prevention of CDI recurrence in solid organ transplant recipients
Study Center(s) Five sites in the United States

Primary Objectives

Evaluate the safety and efficacy of FMT compared to oral vancomycin for the prevention of CDI recurrence in SOT recipients

Secondary Objectives

  • Assess the CDI-related quality of life in SOT recipients treated with FMT compared with oral vancomycin
  • Compare the change in gut microbiota using multiple metrics of microbiota structure and function and to evaluate the association between the change in gut microbiota and recurrence of CDI
  • Evaluate the short- and medium-term safety of FMT delivered via enema in SOT patients
  • Compare the effects of FMT and oral vancomycin on intestinal colonization by multidrug-resistant organisms other than C. difficile in SOT recipients.
Main Eligibility Criteria Adult Solid Organ Transplant (SOT) recipients with at least a first recurrence of CDI.
Study Product MTP-101-C: screened, freeze-dried, encapsulated fecal microbiota from healthy human donors.
FDA Status The Food & Drug Administration (FDA) considers fecal microbiota preparations for transplantation an investigational new drug (IND).
Reference Therapy 125 mg oral vancomycin every 6 hours for 10 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days.
Sample Size A total of 158 subjects will be recruited from 5 study sites (i.e., approximately 30 subjects per site).
Study Duration Study enrollment and follow-up will occur over 4 years. The duration of the study for each subject is approximately 30 weeks.