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Microbiome Restoration
Fecal Microbiota Transplantation for Diverticulitis
Phase < 1
Recruiting
Led By Justin A Maykel, MD
Research Sponsored by Justin Maykel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recipient: One or more prior episode(s) of uncomplicated diverticulitis, as confirmed by imaging and clinical symptoms
Recipient: Eligible for surgical resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test whether fecal microbiota transplantation (FMT) is a safe and effective treatment for people with diverticulitis that has not responded to other treatments.
Who is the study for?
This trial is for adults over 18 who have had at least one episode of uncomplicated diverticulitis, confirmed by imaging and symptoms. It's aimed at those eligible for surgical resection but are exploring other options.Check my eligibility
What is being tested?
The study tests Fecal Microbiota Transplantation (FMT) as a treatment for diverticulitis. The goal is to see if transferring healthy gut bacteria into patients can improve their condition without surgery.See study design
What are the potential side effects?
Potential side effects may include discomfort or infection at the transplant site, changes in bowel habits, abdominal pain, and possible allergic reactions to the transplanted material.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one episode of diverticulitis confirmed by tests.
Select...
I am eligible for surgery to remove my cancer.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Necessity for surgery
Number of courses of antibiotics required for the treatment of diverticulitis since FMT
Number of diverticular flares/attacks since FMT
+1 moreSide effects data
From 2016 Phase 1 trial • 23 Patients • NCT0210882148%
Abdominal Pain
22%
Flatulence and bloating
22%
Diarrhea
13%
Emesis
9%
Bloody stools
9%
Nausea
4%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fecal Microbiota Transplantation
Trial Design
1Treatment groups
Experimental Treatment
Group I: FMT cohortExperimental Treatment1 Intervention
This will be a single-arm pilot study of patients with uncomplicated diverticulitis. All subjects enrolled as recipients will undergo FMT via colonoscopy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation (FMT)
2016
Completed Phase 1
~170
Find a Location
Who is running the clinical trial?
Justin MaykelLead Sponsor
University of Massachusetts, WorcesterLead Sponsor
342 Previous Clinical Trials
976,600 Total Patients Enrolled
Justin A Maykel, MDPrincipal InvestigatorUMass Chan Medical School
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at high risk for infections that don't respond to standard antibiotics.I have a history of gastrointestinal issues.I use natural family planning methods only and am sexually active.I am 18 years old or older.I am under 18 years old.I have had major surgery in my stomach or abdomen area before.I have a history of diverticulitis.I have had at least one episode of diverticulitis confirmed by tests.I am eligible for surgery to remove my cancer.I have had a blockage in my intestines within the last year.I am unable to give informed consent by myself.I do not have any major illnesses that could increase my risks.I recently had COVID-19 or was exposed to it within the last 8 weeks.I am currently experiencing a flare-up of diverticulitis.I have had a fecal transplant before.I am currently pregnant or breastfeeding.I am older than 18 years.I'm sorry, this criterion seems incomplete. Could you please provide more context or information?I am a candidate for surgery to remove my cancer.I have had at least one episode of diverticulitis confirmed by tests.I am older than 18.
Research Study Groups:
This trial has the following groups:- Group 1: FMT cohort
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.
What is the current enrollment figure for this clinical trial?
"Indeed, information on clinicaltrials.gov demonstrates that this research endeavour is actively looking to recruit patients. This trial was initially posted on April 7th 2022 and last modified on May 9th 2022; 10 individuals are being sought after at a single facility."
Answered by AI
Is the opportunity for participation in this research still available?
"This trial is in search of enrollees, with the original posting occurring on April 7th 2022 and the most recent update being conducted May 9th 2022. The information can be found on clinicaltrials.gov."
Answered by AI
Who else is applying?
What state do they live in?
Texas
New York
How old are they?
18 - 65
What site did they apply to?
UMASS Memorial Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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