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Fecal Microbiota Transplant
Fecal Transplant for Ulcerative Colitis
Phase 1
Waitlist Available
Led By Byron Vaughn, MD
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 12 weeks
Awards & highlights
Study Summary
This trial will test whether or not reducing the amount of sulfate-reducing bacteria in the gut can help treat ulcerative colitis.
Who is the study for?
This trial is for individuals with active ulcerative colitis confirmed by endoscopy, inflammation extending beyond 20cm, and a diagnosis older than 3 months. Participants must be on stable UC therapy for at least 4 weeks prior to the study, able to consent, and English-speaking. Excluded are those with very low neutrophil counts, extensive bowel surgery history, certain other colitis types or complications like fistulas or abscesses, pregnant women, short life expectancy (<6 months), stoma carriers, recent probiotic users or severe food allergies.Check my eligibility
What is being tested?
The study tests if transplanting fecal microbiota with low sulfur-reducing bacteria (SRB) from donors into patients can reduce SRB levels in people with ulcerative colitis. The goal is to see if this can alter the gut environment favorably against UC-related inflammation.See study design
What are the potential side effects?
While not explicitly listed here, fecal transplants may cause digestive discomforts such as bloating and diarrhea. 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Engraftment of low sulfate reducing microbiota
Secondary outcome measures
Clinical efficacy of FMT versus placebo
Clinical efficacy of low sulfate reducing microbiota
Rate of change of sulfate reducing microbiota
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: FMT TreatmentActive Control1 Intervention
Fecal microbiota - 1.0-3.0 x 10^11 CFU / day (2 capsules per day for 8 weeks).
Group II: PlaceboPlacebo Group1 Intervention
The placebo consists of a mixture of trehalose and crystalline methylcellulose (Avicel) in 6:1 (w/w) ratio that is packaged in size 0 swedish orange capsules, which are then double encapsulated in size 00 natural colored capsules to make them visibly indistinguishable from encapsulated active product. Two capsules taken daily for 8 weeks.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,378 Previous Clinical Trials
1,588,483 Total Patients Enrolled
Byron Vaughn, MDPrincipal InvestigatorUniversity of Minnesota
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with ulcerative colitis based on your symptoms and medical history.You have been diagnosed with ulcerative colitis for more than 3 months.You are pregnant.You have had a large portion of your intestine surgically removed.You may have a condition called ischemic colitis, radiation colitis or microscopic colitis.You have a condition called per-anal fistula or abscess.You are not expected to live more than 6 months.You cannot have taken pre or probiotics 30 days before being selected for the trial.You have severe allergies to certain foods.You have been diagnosed with Crohn's disease.You have severe liver disease or cirrhosis in its final stage.
Research Study Groups:
This trial has the following groups:- Group 1: FMT Treatment
- Group 2: Placebo
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is able to join this experiment?
"This study is accepting around 20 participants between 18 and 89 years old who suffer from ulcer. To be eligible, these criteria must be met."
Answered by AI
Does this research protocol accept participants who are younger than 25?
"This medical trial is open to participants ranging from 18 years of age up until the upper threshold of 89."
Answered by AI
How would you rate the safety of fecal microbiota transplantation?
"Our team at Power gave FMT Treatment a score of 1, as it is currently being tested in Phase 1 trials - meaning there is only minimal data demonstrating its safety and efficacy."
Answered by AI
Are researchers currently signing up participants for this clinical trial?
"According to the clinicaltrials.gov database, this medical trial is not actively recruiting participants at present. Posting of the study was originally on July 31st 2019 and its content most recently modified on September 14th 2022. Although no enrolment is taking place right now, there are 408 other studies that allow for recruitment presently."
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