Fecal Transplantation in Ulcerative Colitis (FMT-CU)

Joint Authority for Päijät-Häme Social and Health Care

Status: Unknown

Conditions: Ulcerative Colitis

Treatments: Other: Fecal microbiota transplantation (FMT); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03561532

HUS / 1652/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

FMT

Active Comparator group

Description:

50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum

Treatment:

Other: Fecal microbiota transplantation (FMT)

Placebo

Placebo Comparator group

Description:

50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum.

Treatment:

Other: Placebo