Fecal Microbiota Transplantation in Postoperative Crohn's Disease
Recruiting · NCT04637438 · Interventional (participants receive a specific treatment) · Lead sponsor: Tampere University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Fecal Microbiota TransplantationPlacebo
What this trial is about
This pilot study aims to detect possible trends or signals suggesting efficacy of FMT on prevention of delay of POR, to determine the safety of FMT in post operative CD, and asses if a full randomised controlled trial is feasible in this setting. With microbiota analysis we aim to assess if changes in gut microbiota are related to disease course of CD after operation.
Who can take part
Age range
18 Years to 120 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed.
- Tampere University Hospital - Tampere, Finland
- Tampere University Hospital - Tampere, Finland