NCT02127398 · Duke University
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
What this study is about
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.
View original scientific 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
BIOLOGICAL
fecal microbiota
fecal microbiota in capsule form
Primary outcome measures
Recurrent colitis due to Clostridium difficile
Time frame: six months
Patients will be followed 1, 7, 28, and 180 days after the treatment and success will be defined as resolution of C. difficile infection without recurrence within a six-month time period. Patients will be assessed by interview and physical exam. Any patients with suspected persisting/recurring C. difficile colitis will undergo further evaluation with a repeat stool C. difficile toxin assay.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Documented intestinal parasite infection without documentation of appropriate treatment
Where
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced Aug 13, 2025 · Source of record for eligibility and locations