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Microbiota Restoration
Fecal Microbiota Transplant for Irritable Bowel Syndrome
Phase 2
Recruiting
Led By Madhusudan Grover, MBBS
Research Sponsored by Madhusudan (Madhu) Grover, MBBS
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 12 weeks
Summary
This trial studies the safety and effectiveness of FMT using donor stool with low protein breakdown and Alistipes putredinis bacteria to treat PI-IBS and high protein breakdown.
Who is the study for?
This trial is for individuals with post-infection irritable bowel syndrome (PI-IBS) who experience moderate to severe symptoms. They must be able to undergo a colonoscopy and not have constipation-dominant IBS. People with recent abdominal surgery, bleeding disorders, low neutrophil count, active cancer, certain GI diseases, or those pregnant or on immune-suppressing drugs cannot participate.
What is being tested?
The study tests the effectiveness of fecal microbiota transplantation (FMT). Participants will receive stool from a donor with specific bacteria thought to help PI-IBS symptoms versus their own stool. The goal is to see if this can reduce protein breakdown in the gut linked to IBS.
What are the potential side effects?
Potential side effects may include discomfort at the transplant site, changes in bowel habits, abdominal pain or bloating. There's also a risk of infection transmission from donor material despite screening.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of responders
Secondary study objectives
Alistipes putredinis proportion post-FMT
Change in level of fecal proteolytic activity
Changes in in vivo excretion of 2-24 hr lactulose excretion
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Donor Fecal Microbiota Transplantation GroupExperimental Treatment1 Intervention
Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor
Group II: Autologous Fecal Microbiota Transplantation GroupPlacebo Group1 Intervention
Subjects will receive a fecal microbiota transplantation (FMT) using their own stool
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Who is running the clinical trial?
Madhusudan (Madhu) Grover, MBBSLead Sponsor
Madhusudan Grover, MBBSPrincipal InvestigatorMayo Clinic
6 Previous Clinical Trials
391 Total Patients Enrolled
3 Trials studying Irritable Bowel Syndrome
309 Patients Enrolled for Irritable Bowel Syndrome
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have constipation-predominant IBS.I can safely have and agree to a colonoscopy.I cannot undergo a colonoscopy with sedation due to severe bowel or medical conditions.I have chronic kidney or liver disease.My cancer is currently active.I haven't taken new probiotics, antibiotics, or NSAIDs in the last 4 weeks.I cannot undergo bowel prep due to severe bowel or medical conditions.I am not taking any medication that affects bowel movement, except for loperamide.I have a weak immune system or am taking medication that weakens it.I have a history of bleeding disorders.My IBS symptoms are moderate to severe.I have not had major abdominal surgery, except for specific minor procedures.I have been diagnosed with post-infectious IBS caused by Campylobacter.I have a diagnosed gastrointestinal condition like IBD, celiac, or colitis.
Research Study Groups:
This trial has the following groups:- Group 1: Donor Fecal Microbiota Transplantation Group
- Group 2: Autologous Fecal Microbiota Transplantation Group
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.
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