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Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

This study is currently recruiting participants.
Verified December 2014 by Marko Kalliomäki, Turku University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01961492
First Posted: October 11, 2013
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Marko Kalliomäki, Turku University Hospital
  Purpose
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.

Condition Intervention Phase
Ulcerative Colitis Other: Fecal microbiota transplantation Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Fecal Microbiota Transplantation Via Colonoscope as an Adjunct Therapy in the Treatment of Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Marko Kalliomäki, Turku University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • Colonic inflammation [ Time Frame: Within 1 year after the intervention ]
    Endoscopic Mayo score at 3 and 12 months after the intervention

  • Adverse events [ Time Frame: Within 1 year after the intervention ]

Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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): NCT01961492


Contacts
Contact: Marko Kalliomäki, MD marko.kalliomaki@utu.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland, 20520
Principal Investigator: Marko Kalliomäki, MD         
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Marko Kalliomäki, MD Turku University Hospital
  More Information

Responsible Party: Marko Kalliomäki, Specialist, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01961492     History of Changes
Other Study ID Numbers: 15881
First Submitted: October 9, 2013
First Posted: October 11, 2013
Last Update Posted: December 3, 2014
Last Verified: December 2014

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