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Microbiota Therapy
Fecal Microbiota Transplant for Chronic Pouchitis
Phase < 1
Waitlist Available
Led By Maia Kayal, MD, MS
Research Sponsored by Maia Kayal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial aims to find out if FMT is a safe and effective treatment for a type of intestinal inflammation.
Who is the study for?
This trial is for adults with chronic pouchitis who rely on antibiotics to stay in remission and have tried stopping antibiotics at least twice, leading to flare-ups. It's not for those with certain pouch strictures, Crohn's-like inflammation, allergies to specific antibiotics used here, pregnant or breastfeeding women, or patients currently on biologics, immunomodulators, steroids or other trials.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of fecal microbiota transplant (FMT) as a treatment option for people suffering from chronic pouchitis. Participants will receive FMT to see if it can help maintain their condition without the need for continuous antibiotic use.See study design
What are the potential side effects?
While not explicitly listed in your provided information, potential side effects of FMT may include abdominal discomfort, bloating, diarrhea or constipation post-transplant. There could also be a risk of infection transmission through the donor stool.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with FMT related adverse events
Secondary outcome measures
Change in B cells
Change in NK cell subsets
Change in T cells
+6 moreSide effects data
From 2019 Phase 1 & 2 trial • 15 Patients • NCT0233065317%
Non-Cardiac Chest Pain
17%
Abnormal Lab Values
17%
Grade 3 Colitis
17%
Eczema/Rash
8%
Sore Throat
8%
Upper Respiratory Infection
8%
Fever
8%
Epiploic Appendagitis
8%
Grade 3 Sinus Tachycardia
8%
Eye Disorder/Blurred Vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fecal Microbiota Transplant (FMT)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota Transplant (FMT)Experimental Treatment1 Intervention
Single arm of 16-18 subjects, all of whom will receive the interventional FMT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplant (FMT)
2015
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
Maia KayalLead Sponsor
Maia Kayal, MD, MSPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have a fever over 100.4F or show signs of being sick.I am currently taking immunomodulators, steroids, or experimental drugs.I have inflammation similar to Crohn's disease in my pouch.I have not had a total proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis.I currently have a digestive system infection.I am currently on biologic treatments like infliximab or adalimumab.I have inflammation limited to the rectal cuff area.I have severe narrowing in parts of my surgical pouch.I am 18 or older with UC and had surgery to create a pouch in my lower belly.I need ongoing antibiotics for pouchitis and have had flare-ups when trying to stop them.I have active pouchitis and have tried at least 4 antibiotic treatments in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Fecal Microbiota Transplant (FMT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings in this research project?
"The information available on clinicaltrials.gov indicates that this study is not currently open for enrollment, with the original post appearing on June 1st 2023 and its most recent update taking place April 12th of the same year. Despite this, 8 other trials are actively recruiting patients at present."
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