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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

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Fecal microbiota transplantation (FMT) Other: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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
Official Title: FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: FMT
50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum
Other: Fecal microbiota transplantation (FMT)
FMT administered into the cecum of the patient in colonoscopy.

Placebo Comparator: Placebo
50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum.
Other: Placebo
Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.




Primary Outcome Measures :
  1. Maintenance of remission of ulcerative colitis [ Time Frame: 52 weeks ]
    Endoscopic remission and Mayo-score < 2



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561532


Locations
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Finland
Helsinki University Hospital
Helsinki, Finland
Päijät-Häme Central Hospital
Lahti, Finland
Sponsors and Collaborators
Joint Authority for Päijät-Häme Social and Health Care
Helsinki University Central Hospital
Helsinki University

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Responsible Party: Joint Authority for Päijät-Häme Social and Health Care
ClinicalTrials.gov Identifier: NCT03561532     History of Changes
Other Study ID Numbers: HUS / 1652/2016
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases