Transplantation of Fecal Microbiota for Clostridium Difficile Infection

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01958463
Study type	Interventional
Source	Tel-Aviv Sourasky Medical Center
Contact	Zamir Halpern, MD
Phone	972-36974282
Email	halpernza@tlvmc.gov.il
Status	Not yet recruiting
Phase	Phase 3
Start date	November 2013
Completion date	December 2016

View Details

See also
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