Actively Recruiting
Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
Led by University of Alberta · Updated on 2025-06-10
69
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
W
Weston Family Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Known diagnosis of ulcerative colitis.
- Measured fecal calprotectin of >250 µg/g at screening.
- Mild disease as defined by Partial Mayo Scoring Index between 0-4 for adults.
- Mild disease as defined by Pediatric UC Activity Index between 0-34 for pediatric patients.
- Pediatric patients must be at Tanner stage 5.
- Weight over 50 kg.
- Stable inflammatory bowel disease medication use without changes in the three months before study start.
- Men and women may participate; women must be menstruating and using contraceptives.
You will not qualify if you...
- Unable to provide informed consent.
- Presence of Crohn disease, IBD unclassified, non-IBD bowel conditions, or motility disorders.
- Use of systemic antibiotics for more than one week during the two months before intervention or any antibiotic use during the intervention.
- Use of probiotic, prebiotic, or fiber supplements affecting the gut microbiome within one month before intervention.
- Chronic use of laxatives or stool softeners.
- History of abdominal surgery, including appendectomy.
- Pregnancy or plans to become pregnant during the study period.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8
Actively Recruiting
Research Team
E
Eytan Wine, MD, PhD
CONTACT
A
Anissa Armet, PhD, RD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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