RECRUITINGPhase 2INTERVENTIONAL
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
Fecal Microbiota Transplantation in Refractory Clostridium Difficile Colitis
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BIOLOGICAL
fecal microbiota
fecal microbiota in capsule form
Locations (1)
Duke University Medical Center
Durham, North Carolina, United States