Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
NCT Number: NCT06515210
Acronym: PAIF-UC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ulcerative Colitis
Interventions: DIETARY_SUPPLEMENT: Acacia Gum|DIETARY_SUPPLEMENT: Microcrystalline Cellulose|DIETARY_SUPPLEMENT: Placebo
Sponsor: University of Alberta
Collaborators: Weston Family Foundation
Sex: ALL
Age: CHILD, ADULT
Enrollment: 69
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12

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.

Primary Outcome Measures: Changes in fecal calprotectin, Calprotectin will be analyzed in fecal samples. Clinically-relevant reductions are defined as levels \<150 µg/g or reduced by at least 50% from baseline., Week 3 and Week 6 (and week 12, if applicable)
Secondary Outcome Measures: Changes in disease activity, Scores obtained from either the Partial Mayo Scoring Index Assessment for adult participants or the Pediatric Ulcerative Colitis Activity Index for pediatric participants., Week 3 and Week 6 (and week 12, if applicable)|Changes in fecal microbiome composition, Fecal microbiome composition will be analyzed using whole metagenome sequencing to measure changes at different taxonomic levels (e.g. genus, species)., Week 3 and Week 6 (and week 12, if applicable)|Changes in function of the fecal microbiome, Fecal microbiome functions will be analyzed using whole metagenome sequencing to measure changes in enzymes and pathways encoded by gut microbiota., Week 3 and Week 6 (and week 12, if applicable)|Changes in gut barrier function: fecal zonulin, Fecal samples will be analyzed for changes in zonulin (ng/mg)., Week 3 and Week 6 (and week 12, if applicable)|Changes in gut barrier function: plasma lipopolysaccharide binding protein, Plasma from blood samples will be analyzed for changes in lipopolysaccharide binding protein (µg/mL)., Week 3 and Week 6 (and week 12, if applicable)|Changes in fecal short-chain fatty acids, Short-chain fatty acids (acetate, propionate, butyrate, valerate) and branched-chain fatty acids (isovalerate, isobutyrate) will be measured in fecal samples using gas chromatography mass spectrometry (µmol/g)., Week 3 and Week 6 (and week 12, if applicable)|Changes in fecal bile acids, Bile acid derivatives will be measured in fecal samples using ultrahigh performance liquid chromatography/multiple-reaction monitoring-mass spectrometry (nmol/g)., Week 3 and Week 6 (and week 12, if applicable)|Changes in fecal pH, Fecal pH will be measured using a pH meter., Week 3 and Week 6 (and week 12, if applicable)|Changes in fecal dry mass percentage, Fecal moisture content, or percentage of dry mass, will be measured by drying fecal material overnight in an oven., Week 3 and Week 6 (and week 12, if applicable)|Changes in the plasma metabolome, Untargeted metabolomics will be applied to plasma samples via high performance chemical isotope labeling liquid chromatography mass spectrometry platform., Week 3 and Week 6 (and week 12, if applicable)|Changes in the plasma inflammatory cytokines, Several inflammatory cytokines (e.g., TNF-α, IL-6) will be analyzed in plasma samples using multiplex, electrochemiluminescence assays., Week 3 and Week 6 (and week 12, if applicable)|Changes in routine clinical bloodwork, Routine clinical bloodwork will be performed for patients (e.g., C-reactive protein, liver enzymes, albumin, etc.), Week 3 and Week 6 (and week 12, if applicable)|Changes in body weight, Body weight will be measured in kilograms and will be used to calculate body mass index., Week 3 and Week 6 (and week 12, if applicable)|Changes in gastrointestinal symptoms, Individual gastrointestinal symptoms will be measured by a gastrointestinal symptom questionnaire (scored on a scale of 0-5; higher scores indicating more symptoms)., Week 3 and Week 6 (and week 12, if applicable)|Changes in dietary intake, Dietary intake will be measured by 24 hour dietary recalls (using ASA-24)., Week 3 and Week 6 (and week 12, if applicable)|Changes in patient quality of life, Patient quality of life will be evaluated using the EQ-5D-5L questionnaire., Week 3 and Week 6 (and week 12, if applicable)|Need for rescue therapy, Changes to patient therapy regimes (e.g., steroids, dose escalation), inability to complete the study, and adverse events related to the intervention will be monitored and analyzed., Week 3 and Week 6 (and week 12, if applicable)
Other Outcome Measures: Biopsies, Brushings, Intestinal Washes, and Endoscopy Scores, In those participants who voluntarily extend their treatment for an additional six weeks, if a clinical decision is made by the patient and physician to perform sigmoidoscopy or colonoscopy, biosamples (biopsies, brushing, and intestinal washes) and data (endoscopy scores) will be collected from these procedures if patients agree. The procedure will not be a research procedure, but the patients will be approached and consented for biosample collection., Week 12