Recruiting

Acacia Gum & MCC

Sponsor:

University of Alberta

Code:

NCT06515210

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

Acacia Gum

Microcrystalline Cellulose

Placebo

Study Details

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.

Conditions

Ulcerative Colitis

Study ID

NCT06515210

Start date

Jun 3, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Known diagnosis of ulcerative colitis.
  • Evidence of active disease, defined as either 1) measured FCP >100 µg/g at screening, OR 2) Partial Mayo Scoring Index Assessment for UC ≥2 (adult patients) OR Pediatric UC Activity Index (PUCAI) ≥10 (pediatric patients). Patients who are in clinical remission (Partial Mayo <2 or PUCAI <10) that have active inflammation (elevated FCP >100 µg/g) would also be eligible, as will patients with active symptoms, regardless of availability of FCP.
  • Tanner stage ≥4 for pediatric patients.
  • Weight >40kg.
  • 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 that use adequate contraceptive methods.
  • Able to maintain current lifestyle (diet, exercise, supplements/medications, and sleep) throughout study.

Exclusion Criteria:

  • Inability to provide informed consent.
  • Presence of Crohn disease, IBD unclassified, non-IBD bowel conditions (e.g., celiac), or motility disorder.
  • Presence of abnormal constrictions of the gastrointestinal tract, diseases of the esophagus and/or the superior opening of the stomach (cardia), potential or existing intestinal blockage, paralysis of the intestine, megacolon, fecal impaction, inflamed bowel or appendicitis, or have failed to defecate after taking another laxative.
  • History of significant chronic disorders such as severe cardiac disease, malignancy requiring systemic chemotherapy or radiation therapy, significant renal failure, severe pulmonary disease, kidney disorders, diabetes, arthritis, multiple sclerosis, or other immune-mediated conditions requiring systemic therapy.
  • Presence of serious infection (e.g., infectious colitis).
  • Presence of severe anemia, defined as hemoglobin <100 g/L or considered clinically significant based on physician discretion.
  • Presence of disease or condition that negatively impacts ability to swallow, which may interfere with intake of supplement.
  • Use of systemic antibiotics for more than a week during two months prior to intervention, or any antibiotic use during the intervention.
  • Use of medications that inhibit peristaltic movement (e.g. opioids, loperamide)
  • Consistent use of topical therapies (e.g., rectal suppositories, enemas) for at least a week, with a resulting improvement in symptoms (defined based on physician discretion).
  • Use of probiotic, prebiotic, or fibre supplements in month prior to intervention or during the course of the trial that are 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, stool softeners, or anti-diarrheal medications.
  • Chronic use of illicit drugs and/or excessive alcohol (e.g., average of >7 drinks/week).
  • Current smoker (cigarettes).
  • History of abdominal surgery, including appendectomy.
  • Pregnancy or intention of the patient to become pregnant during the study period.
  • Breastfeeding.
  • Allergy to any ingredients of investigational products or placebo (i.e., acacia gum, microcrystalline cellulose, or maltodextrin).
  • Unable to maintain high fiber intake through supplementation during intervention.

Study Design

Enrollment

69 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Acacia Gum

Participants (n=23) incorporate the fibre supplement into their usual diet daily.

Microcrystalline Cellulose

Participants (n=23) incorporate the fibre supplement into their usual diet daily.

Placebo

Participants (n=23) incorporate the placebo into their usual diet daily.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Eytan Wine, MD, PhD

(780) 248-5494wine@ualberta.ca

Anissa Armet, PhD, RD

aarmet@ualberta.ca

Locations

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2X8

Contacts

Eytan Wine, MD, PhD

780-492-2223wine@ualberta.ca

Anissa Armet, PhD, RD

aarmet@ualberta.ca

Principal Investigator:

Eytan Wine, MD, PhD

More Information

Sponsor

University of Alberta

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • inflammatory bowel disease
  • ulcerative colitis
  • dietary fibre
  • gut microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-06-05.