Fecal Transplantation in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— FMT-CU  

Official title:

FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03561532
• Other study ID #: HUS / 1652/2016
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: May 31, 2020

Study information

• Verified date: August 2019
• Source: Joint Authority for Päijät-Häme Social and Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Fecal microbiota transplantation (FMT)
FMT administered into the cecum of the patient in colonoscopy.
• Placebo
Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Päijät-Häme Central Hospital	Lahti

Sponsors (3)

Lead Sponsor	Collaborator
Joint Authority for Päijät-Häme Social and Health Care	Helsinki University, Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of remission of ulcerative colitis	Endoscopic remission and Mayo-score < 2	52 weeks