Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
ConditionUlcerative Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Acacia Gum
Dietary supplementParticipants (n=23) incorporate the fibre supplement into their usual diet daily.
Microcrystalline Cellulose
Dietary supplementParticipants (n=23) incorporate the fibre supplement into their usual diet daily.
Placebo
Dietary supplementParticipants (n=23) incorporate the placebo into their usual diet daily.
Treatment groups
69 Participants
are divided into 3 treatment groupsGroup A: Acacia GumExperimental treatment 1 intervention
Group B: Microcrystalline CelluloseExperimental treatment 1 intervention
Group C: MaltodextrinPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in fecal calprotectin
Calprotectin will be analyzed in fecal samples. Clinically-relevant reductions are defined as levels \<100 µg/g or reduced by at least 50% from baseline.
Time frame
Week 3 and Week 6 (and week 12, if applicable)Secondary outcomes
1
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.
Time frame
Week 3 and Week 6 (and week 12, if applicable)2
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).
Time frame
Week 3 and Week 6 (and week 12, if applicable)3
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.
Time frame
Week 3 and Week 6 (and week 12, if applicable)4
Changes in gut barrier function: fecal zonulin
Fecal samples will be analyzed for changes in zonulin (ng/mg).
Time frame
Week 3 and Week 6 (and week 12, if applicable)Other outcomes
1
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.
Time frame
Week 12Sponsors and contacts
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Source ClinicalTrials.gov