Status:
RECRUITING
Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Weston Family Foundation
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
15-60 years
Phase:
NA
Brief Summary
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 colit...
Detailed Description
Prevalence and incidence of inflammatory bowel diseases (IBD), including ulcerative colitis (UC), is rising rapidly in Canada and the rates are amongst the highest globally (Crohn's and Colitis Canada...
Eligibility Criteria
Inclusion
- Known diagnosis of ulcerative colitis.
- Measured fecal calprotectin of \>250 µg/g at screening.
- Mild disease: Partial Mayo Scoring Index Assessment for UC between 0-4 (adult patients).
- Mild disease: Pediatric UC Activity Index (PUCAI) between 0-34 (pediatric patients).
- Tanner stage 5 for pediatric patients.
- Weight \>50kg.
- No changes to IBD-related medications in three months prior to study onset (stable therapy, including use of 5-aminosalicylic acid, biologics, and immunosuppressive medications; some minor adjustments allowed, such as increasing dose for weight change, or change to a compatible/generic treatment).
- Men and women; the latter must be menstruating and using contraceptives.
Exclusion
- Inability to provide informed consent.
- Presence of Crohn disease, IBD unclassified, non-IBD bowel conditions (e.g., celiac), or motility disorder.
- Use of systemic antibiotics for more than a week during two months prior to intervention, or any antibiotic use during the intervention.
- Use of probiotic, prebiotic, or fibre supplements in month prior to intervention known to affect the gut microbiome (if these are present in foods, such as yogurt or fermented foods, this will be allowed).
- Chronic use of laxatives or stool softeners.
- History of abdominal surgery, including appendectomy.
- Pregnancy or intention of the patient to become pregnant during the study period.
Key Trial Info
Start Date :
June 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06515210
Start Date
June 3 2025
End Date
December 1 2026
Last Update
June 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8