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FMT for Crohn's Disease
Phase 1
Waitlist Available
Led By Byron Vaughn, MD, MS
Research Sponsored by University of Minnesota
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
No Placebo-Only Group
Summary
This trial tests if taking healthy bacteria from donor stool by capsules or colonoscopy can help people with Crohn's disease who have had surgery. The goal is to see if this can prevent the disease from coming back by balancing their gut bacteria.
Who is the study for?
This trial is for adults over 18 with Crohn's Disease who've had ileocecal resection surgery. They must have been diagnosed at least 6 months ago, speak English, and be on stable medications for a month. Women should use birth control or abstain from sex. Participants can't join if they're pregnant, have certain polyps or colectomies, used probiotics or antibiotics recently, expect surgeries during the study, have very low neutrophil counts, severe food allergies, short life expectancy or advanced liver disease.
What is being tested?
The trial tests whether fecal microbiota transplant (FMT) via capsules has similar effects in increasing beneficial gut bacteria as FMT delivered through colonoscopy in post-surgery Crohn's patients. Participants will randomly receive either capsule FMT (cap-FMT) or colonoscopic FMT (colo-FMT), and their gut bacteria will be assessed through biopsies taken during a follow-up colonoscopy after eight weeks.
What are the potential side effects?
Potential side effects of both cap-FMT and colo-FMT may include digestive discomforts such as bloating and cramps; there could also be risks associated with the colonoscopy procedure itself like bleeding or perforation of the bowel wall.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ileal-associated microbiota engraftment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Capsule fecal microbiota material (cap-FMT)Experimental Treatment1 Intervention
Participants will receive colonoscopy at day 0 and week 8 and receive cap-FMT orally for five days post-colonoscopy. Stool swabs and samples will be collected regularly.
Group II: Colonoscopic fecal microbiota material (colo-FMT) plus placeboActive Control1 Intervention
Participants will receive colonoscopy at day 0 and week 8 and receive a placebo orally for five days post-colonoscopy. During the first colonoscopy, colo-FMT will be administered. Stool swabs and samples will be collected regularly.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Crohn's Disease often target the gut microbiota to restore a healthy balance of bacteria, which is crucial for reducing inflammation and maintaining remission. Fecal Microbiota Transplant (FMT) involves transferring stool from a healthy donor to the patient's gastrointestinal tract to reintroduce beneficial bacteria.
This can help to modulate the immune response, reduce inflammation, and improve gut health. For Crohn's Disease patients, restoring a healthy gut microbiome is essential as it can prevent disease recurrence after surgery and improve overall gastrointestinal function, leading to better disease management and quality of life.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,436 Previous Clinical Trials
1,621,663 Total Patients Enrolled
Byron Vaughn, MD, MSPrincipal InvestigatorUniversity of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.You are expected to take antibiotics during the study.You currently have a surgically created opening in your abdomen to divert waste.You have advanced liver disease or cirrhosis.You have had surgery to remove part of your intestine due to Crohn's disease.You have had surgery to remove all or part of your colon.You have taken probiotics in the past two weeks.You have a severe allergy to certain foods.You are not expected to live for more than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Capsule fecal microbiota material (cap-FMT)
- Group 2: Colonoscopic fecal microbiota material (colo-FMT) plus placebo
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.