Personalized Anti-Inflammatory Fibres in Ulcerative Colitis

NCT06515210 | Recruiting DMC

• 1 other identifier: Pro00137948
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis

Keywords

inflammatory bowel disease; ulcerative colitis; dietary fibre; gut microbiome

Outcome Measures

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.

  Week 3 and Week 6 (and week 12, if applicable)

Secondary Outcomes (17)

• Changes in disease activity

  Week 3 and Week 6 (and week 12, if applicable)

• Changes in fecal microbiome composition

  Week 3 and Week 6 (and week 12, if applicable)

• Changes in function of the fecal microbiome

  Week 3 and Week 6 (and week 12, if applicable)

• Changes in gut barrier function: fecal zonulin

  Week 3 and Week 6 (and week 12, if applicable)

• Changes in gut barrier function: plasma lipopolysaccharide binding protein

  Week 3 and Week 6 (and week 12, if applicable)

Other Outcomes (1)

• Biopsies, Brushings, Intestinal Washes, and Endoscopy Scores

  Week 12

Study Arms (3)

Acacia Gum

EXPERIMENTAL

Acacia gum is a dietary fibre with low-viscosity and is fermentable. Female participants consume 12.5 grams each day for the first two days of the intervention, then consume 25 grams each day for the rest of the six-week intervention. Male participants consume 17.5 grams each day for the first two days of the intervention, then consume 35 grams each day for the rest of the six-week intervention. Those participants who voluntarily extend their treatment for an additional six weeks will continue with consuming the full dose daily.

Dietary Supplement: Acacia Gum

Microcrystalline Cellulose

EXPERIMENTAL

Microcrystalline cellulose is a dietary fibre that is non-viscous and and non-fermentable. Female participants consume 12.5 grams each day for the first two days of the intervention, then consume 25 grams each day for the rest of the six-week intervention. Male participants consume 17.5 grams each day for the first two days of the intervention, then consume 35 grams each day for the rest of the six-week intervention. Those participants who voluntarily extend their treatment for an additional six weeks will continue with consuming the full dose daily.

Dietary Supplement: Microcrystalline Cellulose

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin is a digestible carbohydrate. It is provided in isocaloric doses to the dietary fibres. Female participants consume 6.3 grams each day for the first two days of the intervention, then consume 12.5 grams each day for the rest of the six-week intervention. Male participants consume 8.8 grams each day for the first two days of the intervention, then consume 17.5 grams each day for the rest of the six-week intervention.

Dietary Supplement: Placebo

Interventions

Acacia Gum DIETARY_SUPPLEMENT

Participants (n=23) incorporate the fibre supplement into their usual diet daily.

Also known as: AGRI-SPRAY ACACIA® R, Agrigum International

Acacia Gum

Placebo DIETARY_SUPPLEMENT

Participants (n=23) incorporate the placebo into their usual diet daily.

Also known as: GLUCIDEX® IT 19 - MALTODEXTRIN, ROQUETTE

Maltodextrin

Microcrystalline Cellulose DIETARY_SUPPLEMENT

Participants (n=23) incorporate the fibre supplement into their usual diet daily.

Also known as: MICROCEL® MC-12, ROQUETTE

Microcrystalline Cellulose

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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), 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 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 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).
• Current smoker (cigarettes).
• History of abdominal surgery, including appendectomy.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2X8, Canada

RECRUITING

Related Publications (13)

• Crohn's and Colitis Canada. Impact of inflammatory bowel disease in Canada. Available from: https://crohnsandcolitisca/About-Us/Resources-Publications/Impact-of-IBD-Report2023.

  BACKGROUND

• Kayal M, Shah S. Ulcerative Colitis: Current and Emerging Treatment Strategies. J Clin Med. 2019 Dec 30;9(1):94. doi: 10.3390/jcm9010094.

  PMID: 31905945 BACKGROUND

• Michail S, Durbin M, Turner D, Griffiths AM, Mack DR, Hyams J, Leleiko N, Kenche H, Stolfi A, Wine E. Alterations in the gut microbiome of children with severe ulcerative colitis. Inflamm Bowel Dis. 2012 Oct;18(10):1799-808. doi: 10.1002/ibd.22860. Epub 2011 Dec 14.

  PMID: 22170749 BACKGROUND

• Nagao-Kitamoto H, Shreiner AB, Gillilland MG 3rd, Kitamoto S, Ishii C, Hirayama A, Kuffa P, El-Zaatari M, Grasberger H, Seekatz AM, Higgins PD, Young VB, Fukuda S, Kao JY, Kamada N. Functional Characterization of Inflammatory Bowel Disease-Associated Gut Dysbiosis in Gnotobiotic Mice. Cell Mol Gastroenterol Hepatol. 2016 Mar 3;2(4):468-481. doi: 10.1016/j.jcmgh.2016.02.003. eCollection 2016 Jul.

  PMID: 27795980 BACKGROUND

• Britton GJ, Contijoch EJ, Mogno I, Vennaro OH, Llewellyn SR, Ng R, Li Z, Mortha A, Merad M, Das A, Gevers D, McGovern DPB, Singh N, Braun J, Jacobs JP, Clemente JC, Grinspan A, Sands BE, Colombel JF, Dubinsky MC, Faith JJ. Microbiotas from Humans with Inflammatory Bowel Disease Alter the Balance of Gut Th17 and RORgammat+ Regulatory T Cells and Exacerbate Colitis in Mice. Immunity. 2019 Jan 15;50(1):212-224.e4. doi: 10.1016/j.immuni.2018.12.015.

  PMID: 30650377 BACKGROUND

• Di Rosa C, Altomare A, Imperia E, Spiezia C, Khazrai YM, Guarino MPL. The Role of Dietary Fibers in the Management of IBD Symptoms. Nutrients. 2022 Nov 11;14(22):4775. doi: 10.3390/nu14224775.

  PMID: 36432460 BACKGROUND

• Limketkai BN, Gordon M, Mutlu EA, De Silva PS, Lewis JD. Diet Therapy for Inflammatory Bowel Diseases: A Call to the Dining Table. Inflamm Bowel Dis. 2020 Mar 4;26(4):510-514. doi: 10.1093/ibd/izz297.

  PMID: 31819987 BACKGROUND

• So D, Whelan K, Rossi M, Morrison M, Holtmann G, Kelly JT, Shanahan ER, Staudacher HM, Campbell KL. Dietary fiber intervention on gut microbiota composition in healthy adults: a systematic review and meta-analysis. Am J Clin Nutr. 2018 Jun 1;107(6):965-983. doi: 10.1093/ajcn/nqy041.

  PMID: 29757343 BACKGROUND

• Parada Venegas D, De la Fuente MK, Landskron G, Gonzalez MJ, Quera R, Dijkstra G, Harmsen HJM, Faber KN, Hermoso MA. Short Chain Fatty Acids (SCFAs)-Mediated Gut Epithelial and Immune Regulation and Its Relevance for Inflammatory Bowel Diseases. Front Immunol. 2019 Mar 11;10:277. doi: 10.3389/fimmu.2019.00277. eCollection 2019.

  PMID: 30915065 BACKGROUND

• Levine A, Sigall Boneh R, Wine E. Evolving role of diet in the pathogenesis and treatment of inflammatory bowel diseases. Gut. 2018 Sep;67(9):1726-1738. doi: 10.1136/gutjnl-2017-315866. Epub 2018 May 18.

  PMID: 29777041 BACKGROUND

• Desai MS, Seekatz AM, Koropatkin NM, Kamada N, Hickey CA, Wolter M, Pudlo NA, Kitamoto S, Terrapon N, Muller A, Young VB, Henrissat B, Wilmes P, Stappenbeck TS, Nunez G, Martens EC. A Dietary Fiber-Deprived Gut Microbiota Degrades the Colonic Mucus Barrier and Enhances Pathogen Susceptibility. Cell. 2016 Nov 17;167(5):1339-1353.e21. doi: 10.1016/j.cell.2016.10.043.

  PMID: 27863247 BACKGROUND

• Earle KA, Billings G, Sigal M, Lichtman JS, Hansson GC, Elias JE, Amieva MR, Huang KC, Sonnenburg JL. Quantitative Imaging of Gut Microbiota Spatial Organization. Cell Host Microbe. 2015 Oct 14;18(4):478-88. doi: 10.1016/j.chom.2015.09.002. Epub 2015 Oct 1.

  PMID: 26439864 BACKGROUND

• Gill SK, Rossi M, Bajka B, Whelan K. Dietary fibre in gastrointestinal health and disease. Nat Rev Gastroenterol Hepatol. 2021 Feb;18(2):101-116. doi: 10.1038/s41575-020-00375-4. Epub 2020 Nov 18.

  PMID: 33208922 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Gum Arabic; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Eytan Wine, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eytan Wine, MD, PhD

CONTACT

(780) 248-5494; wine@ualberta.ca

Anissa Armet, PhD, RD

CONTACT

aarmet@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study is double-blinded. The fibre supplements are provided in individual daily sachets, packaged and code-labelled by researchers not involved in data analysis or patient care to ensure double-blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, parallel-arm, placebo-controlled, six-week clinical trial, with optional 6-week extension for participants in whom the primary outcome is achieved.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 23, 2024
• Study Start: June 3, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication, ending 5 years following publication.
• Access Criteria: Anyone who wishes to access the data may do so to achieve aims in the approved proposal and for individual participant data meta-analysis.

Locations

CA (1)