Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
Not applicable · Testing Acacia Gum and Microcrystalline Cellulose · 1 site · University of Alberta
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Acacia Gum (a dietary supplement) and Microcrystalline Cellulose (a dietary supplement) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 14 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
- Tanner stage ≥4 for pediatric patients.
Plus 4 more requirement(s). There are also 19 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 69 participants are expected to take part.
- Start date: 2025-06-03.
- Main results expected around 2027-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Changes in fecal calprotectin (Week 3 and Week 6 (and week 12, if applicable))
In the researchers’ words
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)?
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | University of Alberta |
| Enrollment | 69 (estimated) |
| Start date | 2025-06-03 |
| Primary completion (est.) | 2027-12 |
| First posted | 2024-07-23 |
| Last updated | 2026-06-05 |
| Official title | Clinical Profiling of Anti-inflammatory Fibre Supplements in Patients With Ulcerative Colitis: Towards Personalized Complementary Strategies. |
| ClinicalTrials.gov ID | NCT06515210 |
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.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Hospital | Edmonton, Alberta | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.