Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis
Primary Purpose
Pouchitis, Ulcerative Colitis
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pouchitis focused on measuring FMT
Eligibility 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 pouchoscopy after 52 weeks
Exclusion Criteria:
- Unable to provide informed consent
- Use of immunosuppressive or biological medication
- Use of corticosteroids
- Acute pouchitis
- Pregnancy
Sites / Locations
- Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
donors feces
patients own feces
Arm Description
Fecal microbiota transplantation (FMT) is performed by experienced endoscopists through flexible endoscopy into the afferent limb. The second FMT is installed via transanal catheter into the pouch 4 weeks after the first FMT.
Fecal microbiota transplantation (FMT) is performed by experienced endoscopists through flexible endoscopy into the afferent limb. The second FMT is installed via transanal catheter into the pouch 4 weeks after the first FMT.
Outcomes
Primary Outcome Measures
Clinical Remission
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
Evaluation of the Changes in Gut Microbiota
Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
Full Information
NCT ID
NCT03378921
First Posted
December 11, 2017
Last Updated
April 1, 2021
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03378921
Brief Title
Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis
Official Title
Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of our study is to investigate the efficacy and safety of fecal microbiota transplantation (FMT) 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.
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 4. Antibiotic treatment has been stopped 36 hours before the first FMT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pouchitis, Ulcerative Colitis
Keywords
FMT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
donors feces
Arm Type
Experimental
Arm Description
Fecal microbiota transplantation (FMT) is performed by experienced endoscopists through flexible endoscopy into the afferent limb. The second FMT is installed via transanal catheter into the pouch 4 weeks after the first FMT.
Arm Title
patients own feces
Arm Type
Placebo Comparator
Arm Description
Fecal microbiota transplantation (FMT) is performed by experienced endoscopists through flexible endoscopy into the afferent limb. The second FMT is installed via transanal catheter into the pouch 4 weeks after the first FMT.
Intervention Type
Biological
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
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 4, 12, 26, and 52.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
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 4, 12, 26, and 52.
Primary Outcome Measure Information:
Title
Clinical Remission
Description
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
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Evaluation of the Changes in Gut Microbiota
Description
Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
Time Frame
54 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 pouchoscopy after 52 weeks
Exclusion Criteria:
Unable to provide informed consent
Use of immunosuppressive or biological medication
Use of corticosteroids
Acute pouchitis
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Lepistö, PhD, MD
Organizational Affiliation
Department of Gastrointestinal Surgery, Helsinki University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
33501942
Citation
Karjalainen EK, Renkonen-Sinisalo L, Satokari R, Mustonen H, Ristimaki A, Arkkila P, Lepisto AH. Fecal Microbiota Transplantation in Chronic Pouchitis: A Randomized, Parallel, Double-Blinded Clinical Trial. Inflamm Bowel Dis. 2021 Oct 20;27(11):1766-1772. doi: 10.1093/ibd/izab001.
Results Reference
derived
Learn more about this trial
Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis
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