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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 below
Select...
I am 18 years old or older.
Select...
I have active inflammation of my pouch with moderate to severe symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks for reporting.

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 • NCT03378921
8%
fever
8%
abdominal pain
8%
fecal urgency
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
879 Previous Clinical Trials
2,596,942 Total Patients Enrolled

Media Library

Fecal Microbiota Transplantation (Microbiota Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT03545386 — Phase 2
Pouchitis Research Study Groups: FMT, Placebo
Pouchitis Clinical Trial 2023: Fecal Microbiota Transplantation Highlights & Side Effects. Trial Name: NCT03545386 — Phase 2
Fecal Microbiota Transplantation (Microbiota Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03545386 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve participants who are over 75 years old?

"The age limit for this trial is set at 18 years or older and 99 years or younger."

Answered by AI

Does the FDA condone fecal microbiota transplantation as a viable medical procedure?

"Fecal microbiota transplantation is in Phase 2 of clinical trials, so there is some data supporting its safety. However, because this treatment is still in development, there is no data yet to support its efficacy."

Answered by AI

How many total individuals are being research in this investigation?

"According to the information available on clinicaltrials.gov, this trial is currently looking for patients to enroll. The posting dates for this trial are from April 17th, 2019 to present, with the last edit happening on April 5th, 2022. So far, 34 people have been enrolled at 1 location."

Answered by AI

Are new patients currently being recruited for this trial?

"The most up-to-date information on clinicaltrials.gov shows that this study is still recruiting patients. This trial was originally posted on April 17th, 2019 and last updated on April 5th, 2022."

Answered by AI

Are there any medical or age restrictions for patients who want to participate in this clinical trial?

"The ideal candidate for this trial is aged 18-99, has a current diagnosis of pouchitis, and meets the other listed inclusion criteria."

Answered by AI
~3 spots leftby Sep 2024