NCT06515210 Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
| NCT ID | NCT06515210 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 69 participants |
| Start Date | 2025-06-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 69 participants in total. It began in 2025-06-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Eytan Wine, MD, PhD
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT06515210 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 60 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06515210 currently recruiting?
Yes, NCT06515210 is actively recruiting participants. Contact the research team at wine@ualberta.ca for enrollment information.
Where is the NCT06515210 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT06515210 clinical trial?
NCT06515210 is sponsored by University of Alberta. The principal investigator is Eytan Wine, MD, PhD at University of Alberta. The trial plans to enroll 69 participants.
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