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Refined FMT for Ulcerative Colitis (REFOCUS Trial)
REFOCUS Trial Summary
This trial will study the safety and effectiveness of FMT therapy for UC patients, specifically looking at the gut bacteria Fusobacterium and Sutterella species. Subjects will be randomized to receive antibiotics before or not before FMT therapy.
REFOCUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREFOCUS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.REFOCUS Trial Design
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Who is running the clinical trial?
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- You can take mesalamines in the form of pills or as rectal suppositories.
- Group 1: FMT with Antibiotics
- Group 2: FMT with placebo
- 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
In what demographics are individuals eligible to participate in this clinical experiment?
"This clinical trial seeks to enrol 20 volunteers aged between 18 and 75, who have been diagnosed with Ulcerative colitis for longer than 3 months prior. Notably, participants must exhibit a Partial Mayo score of 4-10 and an endoscopic subscore of at least 2 based on their flexible sigmoidoscopy results."
How many individuals have participated in this clinical experiment?
"Affirmative. According to the data published on clinicaltrials.gov, this research is actively seeking out participants and was first advertised on 11/10/2021; with its most recent update arriving a year later. The goal is to enrol 20 patients from one single centre."
What goals is this clinical trial attempting to accomplish?
"The primary measure of success for this trial, which will occur over the course of 8 Weeks, is assessing the proportion of participants that experience a severe adverse effect. Secondary evaluations consist of determining those with Mayo score 0 endoscopic remission, changes in Erythrocyte Sedimentation Rate (ESR), and Fecal Calprotectin levels."
In what conditions might FMT with Antibiotics be utilized?
"FMT with Antibiotics is a common treatment for candidal vulvovaginitis. This same intervention can also be employed to manage trichomonas infections, dermatitis, and reduce the risk of postoperative infections."
Are those aged sixty and older able to participate in this experiment?
"According to the stated requirements for this experiment, persons over 18 but under 75 are eligible to participate."
Is participation in this trial still available for individuals?
"As per the details on clinicaltrials.gov, this medical trial is in the process of recruiting participants. This protocol was first published on November 10th 2021 and has been recently amended as of November 11st 2022."
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