Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

October 12, 2018 updated by: Marko Kalliomäki, Turku University Hospital

Single Fecal Microbiota Transplantation Via Colonoscope as an Adjunct Therapy in the Treatment of Ulcerative Colitis

The purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20520
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • active ulcerative colitis (PUCAI 10-64) in whom fecal microbiota transplantation via colonoscope can be performed

Exclusion Criteria:

  • severe ulcerative colitis (PUCAI > 65)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fecal microbiota transplantation
A single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment
Other: Fecal microbiota transplantation
A single fecal microbiota transplantation through colonoscope
No Intervention: Standard medical treatment
Standard medical treatment as recommended by the ECCO Guidelines of UC therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity of ulcerative colitis
Time Frame: Within 1 year after the intervention
Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months.
Within 1 year after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colonic inflammation
Time Frame: Within 1 year after the intervention
Change from baseline in the fecal calprotectin at 1 month, 3 months, 6 months, and 12 months.
Within 1 year after the intervention
Colonic inflammation
Time Frame: Within 1 year after the intervention
Endoscopic Mayo score at 3 and 12 months after the intervention
Within 1 year after the intervention
Adverse events
Time Frame: Within 1 year after the intervention
Within 1 year after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Marko Kalliomäki, MD, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 11, 2013

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15881

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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