Randomized Clinical Trial of Standard FMT Treatments
Status:
Withdrawn
Trial end date:
2022-04-30
Target enrollment:
Participant gender:
Summary
This is a single center, randomized, parallel assignment, double-blinded, efficacy and safety
study to be conducted in subjects with recurrent C. difficile Infection (RCDI). Approximately
200 subjects will be enrolled in the study and randomized at 1:1 ratio to receive lyophilized
intestinal bacteria obtained from either single or three donors (group 1 receiving healthy
microbiota collected from single donor 90g stool for 2 consecutive days; group 2 receiving
healthy microbiota collected from three donors 90g stool for 2 consecutive days). All
subjects will be followed for approximately 180 days following FMT treatment for safety.
Phase:
Phase 2
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston