Anti-Inflammatory Fibres for Ulcerative Colitis
(PAIF-UC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to determine the clinical effects of two different dietary fibre supplements, acacia gum (AG) and microcrystalline cellulose (MCC), in patients with ulcerative colitis. The main question it aims to answer is: Can the fibre supplements reduce gut inflammation (fecal calprotectin)?Researchers will compare AG and MCC to a placebo (a look-alike substance that contains no fibre) to see if the fibre supplements improve inflammation in ulcerative colitis.Participants will add their assigned fibre supplement or placebo to their usual diet daily for 6 weeks. They will visit the clinic at baseline, week 3, and week 6 to provide samples (stool, blood) and complete various questionnaires.
Who Is on the Research Team?
Eytan Wine, MD, PhD
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
This trial is for men and women with ulcerative colitis, who have a fecal calprotectin level over 250 µg/g. Women must be menstruating and on contraceptives. Participants should have mild disease severity based on specific scoring indexes, weigh more than 50kg, and not have changed their IBD-related medications in the last three months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive their assigned fibre supplement or placebo daily for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants achieving the primary outcome at week 6 may continue their assigned treatment for an additional 6 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Acacia Gum
- Microcrystalline Cellulose
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Weston Family Foundation
Collaborator
Weston Family Foundation
Collaborator