Placebo Controlled Study of Fecal Microbiota Transplant (FMT) for a First or Second Episode of C. Difficile Infection in Adults Using a Frozen Encapsulated Inoculum

Clostridium Difficile Clinical Trial

Official title: Placebo Controlled Study of Fecal Microbiota Transplant (FMT) for a First or Second Episode of C. Difficile Infection in Adults Using a Frozen Encapsulated Inoculum

Status Terminated

Clinical Trial Summary

The investigators wish to compare Fecal Microbiota Transplant (FMT) capsules to placebo capsules in subjects with TWO episodes of C. difficile. The investigators have numerous subjects and physicians requesting FMT at the time of a second relapse, in order to prevent further hospitalizations, obtain a faster and more durable cure, avoid costly medications like fidaxomicin and oral vancomycin, and "fix" the underlying dysbiosis. In some instances, subjects feel like they are being asked to "get sick again" before they can pursue the most effective option. The investigators propose to study these subjects with a rigorous placebo controlled design, which will contribute significantly to our understanding of the utility of FMT, timing, and the real relapse rates in a tertiary referral center. Subjects who relapse with placebo will by definition have a third episode, meet consensus criteria for FMT, and will be offered "standard" FMT by capsule at that time. Additionally, this study will allow us to further capture safety data, in comparison to placebo capsules and further enhance our understanding of the microbiology of dysbiosis, earlier on in the illness course. Lastly, the investigators may decide to perform a cost analysis.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Clostridium Difficile

• NCT number: NCT02343328
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Terminated
• Phase: Phase 1
• Start date: January 2015
• Completion date: July 29, 2016