Personalized Anti-Inflammatory Fibres in Ulcerative Colitis

Sponsor
University of Alberta
Study ID
NCT06515210
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acacia Gum — DIETARY_SUPPLEMENT
    Participants (n=23) incorporate the fibre supplement into their usual diet daily.
  • Microcrystalline Cellulose — DIETARY_SUPPLEMENT
    Participants (n=23) incorporate the fibre supplement into their usual diet daily.
  • Placebo — DIETARY_SUPPLEMENT
    Participants (n=23) incorporate the placebo into their usual diet daily.

Study Details

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.

Key Dates

First listed
Jul 23, 2024
Start date
Jun 3, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
69 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acacia Gum
    Acacia gum is a dietary fibre with low-viscosity and is fermentable. Female participants consume 12.5 grams each day for the first two days of the intervention, then consume 25 grams each day for the rest of the six-week intervention. Male participants consume 17.5 grams each day for the first two days of the intervention, then consume 35 grams each day for the rest of the six-week intervention. Those participants who voluntarily extend their treatment for an additional six weeks will continue with consuming the full dose daily.
  • Experimental: Microcrystalline Cellulose
    Microcrystalline cellulose is a dietary fibre that is non-viscous and and non-fermentable. Female participants consume 12.5 grams each day for the first two days of the intervention, then consume 25 grams each day for the rest of the six-week intervention. Male participants consume 17.5 grams each day for the first two days of the intervention, then consume 35 grams each day for the rest of the six-week intervention. Those participants who voluntarily extend their treatment for an additional six weeks will continue with consuming the full dose daily.
  • Placebo Comparator: Maltodextrin
    Maltodextrin is a digestible carbohydrate. It is provided in isocaloric doses to the dietary fibres. Female participants consume 6.3 grams each day for the first two days of the intervention, then consume 12.5 grams each day for the rest of the six-week intervention. Male participants consume 8.8 grams each day for the first two days of the intervention, then consume 17.5 grams each day for the rest of the six-week intervention.

Primary Outcome Measure

Changes in fecal calprotectin [ Time Frame: Week 3 and Week 6 (and week 12, if applicable) ]

Central Contacts

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