NCT01958463

Transplantation of Fecal Microbiota for Clostridium Difficile Infection

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recent data have demonstrated beneficial health outcomes of microbiota transplantation for the treatment of Clostridium Difficile infection. The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile recurrent/treatment-resistant infection.

Detailed description

Infections by Clostridium Difficile are common both in the community and among hospitalized patients. It is mostly prevalent following an antibiotic treatment. In recent years the investigators are witnessing an increase in severity, incidence and treatment-resistant cases. Treatment-resistant infection or recurrent infection put the patient at risk for severe complications, such as perforation, septic shock, megacolon and even death. New antibiotic treatments such as Rifaximin and Fidaxomicin are not yet available for routine use in Israel. It is known that normal intestinal microbiota protect against Clostridium Difficile infections, and as early as 1958, researchers have demonstrated that a transplantation of fecal microbiota had a beneficial effect on Clostridium Difficile Infection. In fact, previous data show that microbiota transplantation during colonoscopy, in patients with treatment-resistant infection or recurrent infections, is an effective method with a 90% success rate in a single treatment. The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile infection.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
PROCEDURE	Fecal Microbiota transplantation.	Fecal Microbiota transplantation during colonoscopy.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2013-10-09
• Last updated: 2013-10-09

Locations

1 site across 1 country: Israel