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NCT02127398
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
Conditions: Clostridium Difficile Colitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 77
Sponsor: Duke University
Location: Duke University Medical Center Durham North Carolina
Summary
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 incorporating the stool into capsules that are administered by the oral route.
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 difficile) requiring ongoing antibacterial therapy (antiviral or antifungal therapy is acceptable)
* Current or planned cytotoxic chemotherapy within 14 days of the potential fecal transplantation date
* Life expectancy \
Source: ClinicalTrials.gov (NCT02127398). StuddyBuddy aggregates publicly available trial information.