Using stool transplants to treat recurrent Clostridium difficile colitis
Fecal Microbiota Transplantation in Refractory Clostridium Difficile Colitis
PHASE2 · Duke University · NCT02127398
This study is testing whether taking capsules filled with healthy stool can help people who keep getting C. difficile infections feel better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT02127398 on ClinicalTrials.gov |
What this trial studies
This study aims to treat recurrent Clostridium difficile colitis by restoring the normal gut flora through fecal microbiota transplantation. The approach involves encapsulating stool from healthy donors into capsules that can be taken orally, providing a non-invasive alternative to traditional methods. Patients eligible for the study must have experienced multiple episodes of C. difficile colitis within the past year. The study will monitor patients closely after the administration of the capsules to assess the effectiveness of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have had three or more episodes of C. difficile colitis in the past year.
Not a fit: Patients with active infections requiring ongoing antibacterial therapy or those with inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from recurrent C. difficile colitis.
How similar studies have performed: Previous studies have shown that fecal microbiota transplantation is an effective treatment for recurrent C. difficile colitis, supporting the potential success of this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Gary M Cox, MD — Duke University
- Study coordinator: Gary M Cox, MD
- Email: gary.cox@duke.edu
- Phone: 919-668-3271
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Clostridium Difficile Colitis, C. difficile colitis, fecal microbiota transplantation