Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
Ulcerative ColitisThe 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.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
15 to 60
Critères de participation
Inclusion Criteria:
* Known diagnosis of ulcerative colitis.
* Measured fecal calprotectin of \>250 µg/g at screening.
* Mild disease: Partial Mayo Scoring Index Assessment for UC between 0-4 (adult patients).
* Mild disease: Pediatric UC Activity Index (PUCAI) between 0-34 (pediatric patients).
* Tanner stage 5 for pediatric patients.
* Weight \>50kg.
* 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; the latter must be menstruating and using contraceptives.
Exclusion Criteria:
* Inability to provide informed consent.
* Presence of Crohn disease, IBD unclassified, non-IBD bowel conditions (e.g., celiac), or motility disorder.
* Use of systemic antibiotics for more than a week during two months prior to intervention, or any antibiotic use during the intervention.
* Use of probiotic, prebiotic, or fibre supplements in month prior to intervention 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 or stool softeners.
* History of abdominal surgery, including appendectomy.
* Pregnancy or intention of the patient to become pregnant during the study period.
Lieu de l'étude
University of Alberta Hospital
University of Alberta HospitalEdmonton, Alberta
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- University of Alberta
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06515210