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New treatment option for Ulcerative Colitis
Official title Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
ClinicalTrials.gov ID: NCT06515210
What this study is testing
- What it's testing
- 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)?
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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)...
- History of significant chronic disorders such as severe cardiac disease, malignancy requiring systemic chemotherapy or radiation therapy, significant...
- 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.
See the full eligibility 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...
- 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...
- Men and women that use adequate contraceptive methods.
- Able to maintain current lifestyle (diet, exercise, supplements/medications, and sleep) throughout study.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.