Personalized Anti-Inflammatory Fibres in Ulcerative Colitis

A vizsgálat adatai

Ki végzi

University of Alberta

Azonosító

NCT06515210

A regiszteradat frissítve

2026. június 5.

Eredeti leírás

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)?A teljes eredeti leírásKevesebb

Clinical Profiling of Anti-inflammatory Fibre Supplements in Patients With Ulcerative Colitis: Towards Personalized Complementary Strategies.

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.

Bevonási feltételek: 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.

Kizáró feltételek: 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); Allergy to any ingredients of investigational products or placebo (i.e., acacia gum, microcrystalline cellulose, or maltodextrin); 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 disease or condition that negatively impacts ability to swallow, which may interfere with intake of supplement; History of abdominal surgery, including appendectomy; Presence of severe anemia, defined as hemoglobin <100 g/L or considered clinically significant based on physician discretion; Inability to provide informed consent; Current smoker (cigarettes); Pregnancy or intention of the patient to become pregnant during the study period; Breastfeeding; Unable to maintain high fiber intake through supplementation during intervention.

ClinicalTrials.gov NCT06515210