NCT02127398 Stool Transplants to Treat Refractory Clostridium Difficile Colitis
| NCT ID | NCT02127398 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Duke University |
| Condition | Clostridium Difficile Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 77 participants |
| Start Date | 2016-04 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 77 participants in total. It began in 2016-04 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Gary M Cox, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT02127398 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Clostridium Difficile Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02127398 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02127398 currently recruiting?
Yes, NCT02127398 is actively recruiting participants. Contact the research team at gary.cox@duke.edu for enrollment information.
Where is the NCT02127398 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT02127398 clinical trial?
NCT02127398 is sponsored by Duke University. The principal investigator is Gary M Cox, MD at Duke University. The trial plans to enroll 77 participants.