NCT01973465

Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: OSF Healthcare System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for CDI. The weight of the evidence in the literature suggests that FMT is the most effective treatment for ambulatory outpatients affected by recurrent CDI who fail conventional therapy. The anticipated benefits to research patients enrolled in this study include resolution of chronic diarrhea, return of bowel habits and nutritional status to normal, and resolution of chronic recurrent CDI. FMT involves the endoscopic instillation of freshly obtained stool with millions of live bacteria into the recipient's colon by endoscopic lavage. With any endoscopic procedure, there is a risk of perforated viscous. This is very rare, but the risk is increased with severe CDI. The risk of acquisition of communicable enteric or blood borne pathogen appears to be negligible.

Conditions

• Clostridium Difficile

Interventions

Type	Name	Description
BIOLOGICAL	Stool	Implanting fecal matter via colonscope

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-10-31
• Last updated: 2013-10-31

Locations

1 site across 1 country: United States