Stool Transplants to Treat Refractory Clostridium Difficile Colitis
Recruiting now · Phase 2
Conditions studied: Clostridium Difficile Colitis
In brief
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.
Key facts
- Study ID
- NCT02127398
- Run by
- Duke University
- People needed
- 77
- Starts
- 2016-04-01
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2025-08-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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