Your session is about to expire
← Back to Search
Microbiota Transplant
Poop Transplant for Pouchitis
Phase 2
Recruiting
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients aged 18 or over
Active pouchitis defined as PDAI of 7-18 points
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks
Awards & highlights
Study Summary
This trial will test whether a poop transplant can help people with pouchitis, a serious gut disorder.
Who is the study for?
This trial is for adults over 18 with active pouchitis, which means they have inflammation in their intestinal pouch. Women who can have children must use birth control as per guidelines. People can't join if they can't consent, have a C. difficile infection, severe other illnesses, or are in another trial.Check my eligibility
What is being tested?
The study at McMaster University tests if fecal microbiota transplantation (FMT) helps patients with pouchitis enter remission better than a placebo does. Participants receive either FMT or placebo once weekly for six weeks and are randomly assigned to one of these two groups without knowing which one.See study design
What are the potential side effects?
While the specific side effects aren't listed here, FMT generally may cause discomfort, bloating, diarrhea, or constipation. There's also a risk of infection transmission through the transplanted material.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have active inflammation of my pouch with moderate to severe symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
Secondary outcome measures
compare the fecal microbiome in pouchitis patients in remission versus still active at the end of the trial.
compliance of patients who receive FMT
Side effects data
From 2019 Phase 2 trial • 26 Patients • NCT033789218%
fever
8%
fecal urgency
8%
abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donors Feces
Patients Own Feces
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FMTExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
891 Previous Clinical Trials
2,605,432 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently infected with Clostridium difficile.I am 18 years old or older.I have active inflammation of my pouch with moderate to severe symptoms.I am willing to use birth control as required.I am unable to understand and agree to the study's procedures and risks.
Research Study Groups:
This trial has the following groups:- Group 1: FMT
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger