Fecal Transplantation in Ulcerative Colitis

NCT03561532 | Unknown

• 1 other identifier: HUS / 1652/2016
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Maintenance of remission of ulcerative colitis

  Endoscopic remission and Mayo-score \< 2

  52 weeks

Study Arms (2)

FMT

ACTIVE COMPARATOR

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

Other: Fecal microbiota transplantation (FMT)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Fecal microbiota transplantation (FMT) OTHER

FMT administered into the cecum of the patient in colonoscopy.

FMT

Placebo OTHER

Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• • 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
• years

You may not qualify if:

• 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

Sponsors & Collaborators

• Joint Authority for Päijät-Häme Social and Health Care: lead
• Helsinki University Central Hospital: collaborator
• University of Helsinki: collaborator

Study Sites (2)

Helsinki University Hospital

Helsinki, Finland

Location

Päijät-Häme Central Hospital

Lahti, Finland

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant and the treating personnel are blinded of the randomization result.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in two groups to receive in colonoscopy either a fecal suspension made of their own feces or a fecal suspension of a healthy donor.

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 19, 2018
• Study Start: October 1, 2016
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)