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FMT + Dietary Fiber for Ulcerative Colitis (MINDFUL Trial)
MINDFUL Trial Summary
This trial is testing whether FMT or high fiber supplementation can help patients with UC. All enrolled subjects will provide stool and mucosal samples at each visit to help define how these treatments alter the microbiome and immune cell function.
MINDFUL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMINDFUL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 1 & 2 trial • 50 Patients • NCT03106844MINDFUL Trial Design
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Who is running the clinical trial?
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- I have a history of mild to moderate ulcerative colitis.I am willing to have urine, blood, and stool tests before treatment.I am 18 years old or older.My lower large intestine is healthy and not surgically altered.I have been on a stable dose of steroids or biologic therapy for at least 4 weeks.My ulcerative colitis affects more than 15cm of my colon.I have been diagnosed with primary sclerosing cholangitis.I have tuberculosis, whether active or not.I do not have an ongoing C. difficile or other infections.My Crohn's disease diagnosis was confirmed through a biopsy.I have not had emergency issues like blockages or severe infections.I will stop taking specific antibiotics 2 days before my FMT procedure.I am willing to undergo urine, blood, and stool tests before treatment.I will stop taking specific antibiotics 2 days before my treatment.I am 18 years old or older.I have been on a stable dose of steroids or biologic therapy for at least 4 weeks.My ulcerative colitis is severe, with a Mayo score over 10.My lower large intestine is healthy and not surgically altered.My ulcerative colitis affects more than 15cm of my colon.I have not been treated for cancer in the last 5 years.I have had a fecal microbiota transplant in the past.I have a history of mild to moderate ulcerative colitis.
- Group 1: Investigational FMT
- Group 2: Investigational FMT + psyllium fiber
- Group 3: Placebo FMT +/- psyllium fiber
- 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
Has the FDA sanctioned Fecal Microbiota Transplantation as a viable treatment option?
"The safety of Fecal Microbiota Transplantation is estimated to be a 2 on our internal scale due to the relative lack of data supporting its efficacy in comparison to existing evidence for its safety."
How many participants is this trial accommodating?
"Affirmative, the information hosted on clinicaltrials.gov suggests that this research endeavour is still open for recruitment. It was first advertised on January 31st 2020 and has since been updated on February 14th 2022. The trial calls for 135 participants who will be sourced from 1 particular centre."
Who is eligible to take part in this clinical trial?
"This study is enlisting 135 individuals between the ages of 18 and 89 who have an inflammatory bowel ailment. To be eligible, male or female participants must document a history of mild-to-moderate ulcerative colitis (UC) evidenced by endoscopic exam results at screening colonoscopy which demonstrate active UC ≥ 15 cm with a total Mayo scoring of 4-10 and subscore ≥ 1 plus they must possess an uncut descending colon. Additionally, those receiving steroid or biologic therapy must maintain their dosage for four weeks prior to screening as well as throughout the trial period whilst discontinuing anti-rCDI antibiotics 48 hours"
Is the age eligibility for this research restricted to those under 45?
"This research is open to individuals aged 18 and older, but not exceeding 89 years of age."
Are new participants still being considered for this clinical research?
"Affirmative. According to the data hosted on clinicaltrials.gov, this medical experiment is currently seeking out participants following its initial post date of January 31st 2020 and a recent update made February 14th 2022. The trial requires 135 people at one specific location."
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