Fecal Transplantation in Ulcerative Colitis

Not Applicable

• Conditions: Ulcerative Colitis
• Interventions: Other: Fecal microbiota transplantation (FMT); Other: Placebo

• Registration Number: NCT03561532
• Lead Sponsor: Joint Authority for Päijät-Häme Social and Health Care

Brief Summary

Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.

Detailed Description

80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed).

The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-17
• Study First Posted: 2018-06-19
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-15
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• • • Diagnosis of CU based on clinical, endoscopic, and histological findings.

  • Remission assessed by Mayo score (0 to 1) and F-Calpro (<100 ug/g).
  • Availability of consecutive fecal samples during one year after the diagnosis of CU.
  • Availability of blood sample to study the IBD associated genetic background
  • Compliance to attend ileocolonoscopy and FMT within 3-6 months after the diagnosis of CU and at 52 week
  • 18-75 years

Exclusion Criteria

• Unable to provide informed consent
• Need for any antibiotic therapy within 3 months
• Use of corticosteroids, immunosuppressive or biological medication at the baseline
• Use of any probiotics
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT	Fecal microbiota transplantation (FMT)	50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum
Placebo	Placebo	50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum.

Primary Outcome Measures

Name	Time	Method
Maintenance of remission of ulcerative colitis	52 weeks	Endoscopic remission and Mayo-score \< 2

Trial Locations

Locations (2)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Päijät-Häme Central Hospital; 🇫🇮 Lahti, Finland