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RECRUITING Phase 2 ClinicalTrials.gov

Stool Transplants to Treat Refractory Clostridium Difficile Colitis

Sponsor: Duke University • ClinicalTrials.gov ID: NCT02127398

Registry updated: 2026-08-27
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Description

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.

Interventions

  • fecal microbiota (Biological)
    fecal microbiota in capsule form

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 \<180 days * Diagnosis of inflammatory bowel disease (e.g. Crohn's or ulcerative colitis) * Inability to swallow capsules * Indwelling nasogastric, orogastric, gastrostomy, or jejunostomy tube * History of partial or total gastrectomy * Short gut syndrome requiring total parenteral nutrition * Pregnancy * Documented intestinal parasite infection without documentation of appropriate treatment

Conditions

Clostridium Difficile Colitis

Locations

  • Duke University Medical Center — Durham, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record