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Stool Transplants to Treat Refractory Clostridium Difficile Colitis

RecruitingPhase 2Ages 18 Years - anyAllDuke University
NCT02127398 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • fecal microbiota
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Where

1 site
Duke University Medical Center
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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