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Fecal Transplantation in Ulcerative Colitis (FMT-CU)

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ClinicalTrials.gov Identifier: NCT03561532
Recruitment Status : Active, not recruiting
First Posted : June 19, 2018
Last Update Posted : August 15, 2019
Sponsor:
Collaborators:
Helsinki University Central Hospital
Helsinki University
Information provided by (Responsible Party):
Joint Authority for Päijät-Häme Social and Health Care

Tracking Information
First Submitted Date  ICMJE June 6, 2018
First Posted Date  ICMJE June 19, 2018
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE October 1, 2016
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2018)
Maintenance of remission of ulcerative colitis [ Time Frame: 52 weeks ]
Endoscopic remission and Mayo-score < 2
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03561532 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Transplantation in Ulcerative Colitis
Official Title  ICMJE FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The participant and the treating personnel are blinded of the randomization result.
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Other: Fecal microbiota transplantation (FMT)
    FMT administered into the cecum of the patient in colonoscopy.
  • Other: Placebo
    Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.
Study Arms  ICMJE
  • Active Comparator: FMT
    50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum
    Intervention: Other: Fecal microbiota transplantation (FMT)
  • Placebo Comparator: Placebo
    50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 14, 2019)
48
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2018)
80
Estimated Study Completion Date  ICMJE May 31, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03561532
Other Study ID Numbers  ICMJE HUS / 1652/2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared.
Responsible Party Joint Authority for Päijät-Häme Social and Health Care
Study Sponsor  ICMJE Joint Authority for Päijät-Häme Social and Health Care
Collaborators  ICMJE
  • Helsinki University Central Hospital
  • Helsinki University
Investigators  ICMJE Not Provided
PRS Account Joint Authority for Päijät-Häme Social and Health Care
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP