Fecal Microbiota Transplantation for Pouchitis
Primary Purpose
Pouchitis
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Pouchitis
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 or over
- Active pouchitis defined as PDAI of 7-18 points
- Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance
Exclusion Criteria:
- Participating in another clinical trial
- Unable to give informed consent
- Severe comorbid medical illness
- Concomitant Clostridium difficile infection
Sites / Locations
- McMaster UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FMT
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Remission of pouchitis, defined as a pouchitis disease activity index (PDAI) score of <7, with a decreased from baseline PDAI score of 3 points
Comparison between FMT and placebo arms in remission rates
Secondary Outcome Measures
compliance of patients who receive FMT
Measurement of retention rate of patients who receive FMT
compare the fecal microbiome in pouchitis patients in remission versus still active at the end of the trial.
Analysis of changes using 16S rRNA to look at changes in the bacterial profiles of patients who respond to FMT compared to those who do not
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03545386
Brief Title
Fecal Microbiota Transplantation for Pouchitis
Official Title
Randomized Trial of Fecal Microbiota Transplantation Versus Placebo for the Induction of Remission in Patients With Active Pouchitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized double-blind placebo controlled trial involving a single centre (McMaster University) recruiting patients from Hamilton, ON and the surrounding regions, to evaluate whether fecal microbiota transplantation once weekly for six weeks increases the remission rate compared to placebo in patients with active pouchitis.
Detailed Description
Patients with ulcerative colitis (UC) may undergo colectomy due to a variety of reasons, including medically refractory disease or dysplastic changes of the colon. Ileal-pouch anal anastomosis is often offered to these patients. Unfortunately the pouch commonly develops inflammation, known as pouchitis, which is the most common complication of this procedure and occurs in approximately 50% of patients, with the majority of these patients having multiple episodes.
Although the exact cause of pouchitis is not clear, it is felt that fecal bacteria may be implicated in the cause. Studies have demonstrated changes in the fecal contents of patients with pelvic pouches compared to those with end ileostomies, with higher concentrations of Bacteroides and stool anaerobes identified in those patients with pelvic pouches. Antibiotics are a mainstay of treatment for pouchitis, with randomized controlled trials demonstrating response rates of 70-85% to metronidazole or ciprofloxacin for treatment of acute pouchitis. Unfortunately, recurrent use of systemic antibiotics is associated with adverse events and development of antibiotic resistance.
Fecal Microbiota Transplantation (FMT) is the administration of the supernatant component of stool and water mixture from a healthy screened donor. The donors are screened for numerous infections and pathogens prior to being accepted as donors. FMT has been advocated for some colonic disorders; however it is primarily used in recurrent/refractory Clostridium difficile infections (CDI). A case series from McMaster of over 100 patients and have shown that approximately 90% of patients with recurrent CDI have been cured with FMT. The rationale is that the aberrant colonic microbiome can be replaced with a normal healthy microbiome from a donor. A similar rationale has been applied to ulcerative colitis, and a recent systematic review and meta-analysis conducted by the investigators demonstrated FMT is associated with improved clinical remission and endoscopic healing compared to placebo. It seems possible that changing the intestinal flora in patients with pouchitis could also return the mucosa to a healthy state.
The investigators have conducted the world's first randomized trial of fecal transplant therapy to determine its efficacy and safety in patients with active UC. The investigators found that fecal transplants given once per week for 6 weeks resolved the inflammation in 24% of patients with active UC compared to 5% with placebo. There has been no randomized control trial evaluating the efficacy of FMT for treatment of pouchitis. An initial case series of 8 patients did not find treatment with one administration of FMT via nasogastric administration to be associated with any improvement in clinical response. However a subsequent case series found improvement in 4 out of 5 patients with chronic pouchitis who had multiple FMT treatments over 3-4 weeks. The investigators will conduct a randomized trial at a single centre (McMaster University) comparing fecal transplant therapy (from a healthy donor) versus placebo for six weeks for induction of remission in patients with active pouchitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pouchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FMT
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
Stool from healthy donor administered via enema
Intervention Type
Other
Intervention Name(s)
Placebos
Intervention Description
Saline with food coloring administered via enema
Primary Outcome Measure Information:
Title
Remission of pouchitis, defined as a pouchitis disease activity index (PDAI) score of <7, with a decreased from baseline PDAI score of 3 points
Description
Comparison between FMT and placebo arms in remission rates
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
compliance of patients who receive FMT
Description
Measurement of retention rate of patients who receive FMT
Time Frame
7 weeks
Title
compare the fecal microbiome in pouchitis patients in remission versus still active at the end of the trial.
Description
Analysis of changes using 16S rRNA to look at changes in the bacterial profiles of patients who respond to FMT compared to those who do not
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 or over
Active pouchitis defined as PDAI of 7-18 points
Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance
Exclusion Criteria:
Participating in another clinical trial
Unable to give informed consent
Severe comorbid medical illness
Concomitant Clostridium difficile infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neeraj Narula
Phone
905-521-2100
Ext
73884
Email
narulan@mcmaster.ca
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S4K1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeraj Narula
Phone
9055212100
Ext
73884
Email
narulan@mcmaster.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Fecal Microbiota Transplantation for Pouchitis
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