Stool Transplants to Treat Refractory Clostridium Difficile Colitis

Recruiting Phase 2 Interventional Study
Clostridium Difficile Colitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
77 (estimated)
Sponsor
Duke University · Other
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About This Trial
It has been shown that restoration of the normal makeup of the bowel bacterial population is the most effective way to treat recurrent colitis due to Clostridium difficile. Restoration of the normal bowel bacterial population is best done by transplanting stool from a healthy donor. The investigators wish to transplant stool from healthy donors to treat recurrent C. difficile colitis by incorporat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Study entry is open to adults (\>18 years old) who have had three of more episodes of Clostridium difficile colitis within the previous 12 months. Exclusion Criteria: * Absolute neutrophil count \< 500 cells/mm3 * Active infection at other sites (excluding Clostridium diffic…
Contacts

Gary M Cox, MD

919-668-3271

gary.cox@duke.edu

CONTACT