Actively Recruiting

Phase Not Applicable
Age: 15Years - 60Years
All Genders
NCT06515210

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

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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

Age: 15Years - 60Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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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