Fecal Microbiota Transplantation in Postoperative Crohn's Disease

Tampere University Hospital

Status: Enrolling

Conditions: Crohn Disease

Treatments: Other: Placebo; Other: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04637438

R20041

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

20 participants in 2 patient groups, including a placebo group

Fecal Microbiota Transplantation

Active Comparator group

Treatment:

Other: Fecal Microbiota Transplantation

Plasebo

Placebo Comparator group

Treatment:

Other: Placebo