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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
Study Summary
This trial will help determine if FMT by capsules is as effective as FMT by colonoscopy in restoring good gut bacteria in people with Crohn's disease who have had surgery.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ileal-associated microbiota engraftment
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.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,378 Previous Clinical Trials
1,588,489 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks do people face when using cap-FMT?
"The safety of cap-FMT has been rated a 1 out of 3, as it is currently in Phase 1 trial with little evidence to support its efficacy or security."
Answered by AI
What is the current size of the patient population in this clinical examination?
"Affirmative. The clinical trial profile posted on clinicaltrials.gov reveals that the study, which was initially published on April 20th 2022, is actively searching for participants. Presently, 30 individuals need to be enrolled at a single site."
Answered by AI
Is the recruitment of participants still open for this investigation?
"Affirmative. The information on clinicaltrials.gov attests that the recruitment process for this research project, which was initially uploaded on April 20th 2022 is still active. A total of 30 participants need to be recruited from one medical facility."
Answered by AI
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