Randomized Clinical Trial of Standard FMT Treatments

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.

Timeline

Start

2020-01-10

Primary completion

2022-01-30

Completion

2022-04-30

Outcome

Outcome not reported

Stopped (Business): “No Funding”

Drugs

Indications