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Fecal Microbiota Transplantation in the Treatment of Pouchitis

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ClinicalTrials.gov Identifier: NCT03378921
Recruitment Status : Active, not recruiting
First Posted : December 20, 2017
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Essi Karjalainen, Helsinki University Central Hospital

Brief Summary:
The aim of our study is to investigate the efficacy and safety of fecal transplantation in the treatment of antibiotic dependent chronic pouchitis. This is a double-blinded randomized placebo controlled study. 13 patients receive a fecal transplantation from the healthy tested donor and 13 patients in the control group receive their own feces.

Condition or disease Intervention/treatment Phase
Pouchitis Ulcerative Colitis Biological: Fecal microbiota transplantation Biological: Placebo Phase 2

Detailed Description:

Pouchitis is the most common long term complication among patients with ulcerative colitis who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). The etiology of pouchitis remains unclear. There is significant clinical evidence implicating bacteria in the pathogenesis. It has been shown that fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridium difficile -infection. Case reports have also shown promising results of FMT in patients with inflammatory bowel disease. Currently there is no established effective treatment for chronic antibiotic dependent or refractory pouchitis. The aim of our study is to investigate the efficacy and safety of fecal transplantation in the treatment of chronic pouchitis instead of antibiotic therapy. Another aim is to evaluate phylogenetic analysis of the fecal microbiota trying to find microorganisms contributing to good results in fecal transplantation in IPAA patients.

Patients receive FMTs on weeks 0 and 3. Antibiotic treatment has been stopped 36 hours before the first FMT.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: donors feces
Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 3 weeks after the first FMT.
Biological: Fecal microbiota transplantation
Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 3, 12, 26, and 52.

Placebo Comparator: patients own feces
Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 3 weeks after the first FMT.
Biological: Placebo
Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 3, 12, 26, and 52.




Primary Outcome Measures :
  1. clinical remission [ Time Frame: 52 weeks ]
    Clinical remission at week 52. All criteria need to be met: Pouchitis Disease Activity Index <7 and no need for antibiotic treatment for pouchitis during the follow up


Secondary Outcome Measures :
  1. evaluation of the changes in gut microbiota [ Time Frame: 54 weeks ]
    Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 3, 12, 26, and 52.



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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:

  • Status post of restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis
  • Pouchitis diagnosed by the symptoms and by endoscopy including histology within 6 months prior to FMT
  • Need of frequent or continuous use of antibiotics or probiotics because of the chronic pouchitis
  • Availability of consecutive fecal samples during one year
  • Compliance to attend FMT and control pouchscopy after 52 weeks

Exclusion Criteria:

  • Unable to provide informed consent
  • Use of immunosuppressive or biological medication
  • Use of corticosteroids
  • Acute pouchitis
  • 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): NCT03378921


Locations
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Finland
Helsinki University Central Hospital
Helsinki, Finland
Sponsors and Collaborators
Helsinki University Central Hospital

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Responsible Party: Essi Karjalainen, M.D., Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03378921     History of Changes
Other Study ID Numbers: HelsinkiFMT
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Essi Karjalainen, Helsinki University Central Hospital:
FMT
Additional relevant MeSH terms:
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Colitis, Ulcerative
Pouchitis
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Ileitis
Enteritis
Ileal Diseases