Using fecal microbiota transplantation to help patients with postoperative Crohn's disease
Fecal Microbiota Transplantation in Postoperative Crohn's Disease
NA · Tampere University Hospital · NCT04637438
This study is testing whether fecal microbiota transplantation can help people with Crohn's disease avoid complications after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Tampere University Hospital (other) |
| Locations | 2 sites (Tampere and 1 other locations) |
| Trial ID | NCT04637438 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the potential benefits of fecal microbiota transplantation (FMT) in preventing complications after surgery in patients with Crohn's disease. The study aims to assess the safety of FMT and explore its effects on gut microbiota changes related to disease progression post-operation. By analyzing microbiota, researchers hope to identify trends that could inform future larger randomized controlled trials. The study includes both FMT and placebo interventions to evaluate efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with stricturing or fistulizing Crohn's disease requiring ileocecal or ileal resection.
Not a fit: Patients who are pregnant, have active infections, or are on antibiotics or probiotics at the time of the first colonoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve recovery and reduce complications for patients undergoing surgery for Crohn's disease.
How similar studies have performed: While fecal microbiota transplantation has shown promise in other gastrointestinal conditions, this specific application in postoperative Crohn's disease is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 years * Able to provide written consent * Stricturing and/or fistulizing Crohn's disease needing ileocecal or ileal resection Exclusion Criteria: * Pregnancy * Active infection, abscess or fistula at the time of the first colonoscopy * Life expectancy \<1 year * Unable to provide written consent * Use on antibiotics or probiotics at the time of first colonoscopy
Where this trial is running
Tampere and 1 other locations
- Tampere University Hospital — Tampere, Finland (RECRUITING)
- Tampere University Hospital — Tampere, Finland (RECRUITING)
Study contacts
- Study coordinator: Elina Jokinen, PhD
- Email: elina.jokinen@pshp.fi
- Phone: +3583311611
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: Crohn Disease, Fecal Microbiota Transplantation