Personalized anti-inflammatory fibres for ulcerative colitis

Clinical Profiling of Anti-inflammatory Fibre Supplements in Patients With Ulcerative Colitis: Towards Personalized Complementary Strategies.

This trial will test whether two daily fibre supplements, acacia gum and microcrystalline cellulose, can reduce gut inflammation in people with mild ulcerative colitis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 69 (estimated)
• Ages: 15 Years to 60 Years
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT06515210 on ClinicalTrials.gov

What this trial studies

Participants are randomly assigned to add acacia gum, microcrystalline cellulose, or a placebo powder to their usual diet each day for six weeks. Clinic visits occur at baseline, week 3, and week 6 for stool and blood collection and completion of questionnaires. The primary outcome is change in fecal calprotectin as a marker of gut inflammation, with additional microbiome and clinical measures collected. The trial enrolls adults and older adolescents with mild, stable UC and elevated calprotectin to see if fibre supplementation changes inflammation.

Who should consider this trial

Good fit: Ideal candidates are adults and Tanner stage‑5 adolescents with mild ulcerative colitis, fecal calprotectin >250 µg/g, weight >50 kg, and stable IBD therapy for at least three months.

Not a fit: Patients with Crohn's disease or other non-IBD bowel conditions, severe or unstable UC, recent prolonged antibiotic use, or recent changes in IBD medication are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, a well-tolerated fibre supplement could lower colonic inflammation and offer a safe, low-cost adjunct to current UC treatments.

How similar studies have performed: Previous fibre-based interventions in UC have produced mixed and generally modest results, so this approach is not entirely novel and benefits have been variable.

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.

Where this trial is running

Edmonton, Alberta

• University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Principal investigator: Eytan Wine, MD, PhD — University of Alberta
• Study coordinator: Eytan Wine, MD, PhD

Conditions Ulcerative Colitis; inflammatory bowel disease; ulcerative colitis; dietary fibre; gut microbiome