Ulcerative ColitisPAIF-UCNCT06515210
Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
A study testing Acacia Gum and Microcrystalline Cellulose in people with Ulcerative Colitis, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Acacia Gum and Microcrystalline Cellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jun 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- Pregnancy or intention of the patient to become pregnant during the study period.
- Breastfeeding.
- Allergy to any ingredients of investigational products or placebo (i.e., acacia gum, microcrystalline cellulose, or maltodextrin).
- Unable to maintain high fiber intake through supplementation during intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anissa Armet, PhD, RD contact
Canada1 site, 1 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2X8
Eytan Wine, MD, PhD, 780-492-2223, wine@ualberta.ca
Anissa Armet, PhD, RD, aarmet@ualberta.ca
About this study
Official title: 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.
Read the detailed description
Prevalence and incidence of inflammatory bowel diseases (IBD), including ulcerative colitis (UC), is rising rapidly in Canada and the rates are amongst the highest globally (Crohn's and Colitis Canada, 2023). UC is a chronic disease characterized by colonic inflammation, often inadequately managed in the long-term with immunosuppressive medications that can increase risk of infections and malignancies (Kayal \& Shah, 2019). Alternative, complementary strategies are, therefore, necessary to improve patient outcomes.
A potential target for such strategies may be the gut microbiome, which can predict failure of standard therapy in pediatric UC (Michail et al., 2012). Putative, pro-inflammatory microbes are enriched in patients with IBD compared to healthy controls and disease phenotypes can be transferred via microbiome transplantation into germ-free mice (Nagao-Kitamoto et al., 2016; Birtton et al., 2019), suggesting a causal role of the gut microbiome in IBD. Fibre-based treatments for UC have been proposed and tested for UC but results are mixed, quite modest in many cases, and many gaps remain in defining the most appropriate clinical approach (Di Rosa et al., 2022; Limketkai et al, 2020).
Dietary fibre has great potential as a safe, complementary, microbiome-targeted treatment strategy to reduce inflammation in UC. Food supplementation with fermentable fibres alters microbiome composition (So et al., 2018) and increases microbial production of bioactive metabolites like short-chain fatty acids (SCFAs) that can attenuate inflammation (Parada Venegas et al., 2019; Levine et al., 2018). Provision of growth substrates in the form of fibre also enhances gut barrier function by decreasing mucus degradation, thus reducing bacterial encroachment and immune activation that may drive inflammation (Desai et al., 2016; Earle et al., 2015). However, specific fibre structures elicit distinct health effects due to differences in physicochemical properties (Gill et al., 2020). Therefore, important open questions remain, such as which fibres and physicochemical properties are most beneficial in the context of UC, and are their effects microbiome-dependent?
Hypothesis: Acacia gum (AG; soluble and fermentable fibre) and microcrystalline cellulose (MCC; insoluble and non-fermentable fibre) will decrease gut inflammation in patients with UC, but through different mechanisms given their differences in fermentability.
The overall goal of this study is to determine the clinical effects of AG and MCC in patients with UC, using normalization of FCP as the primary outcome.
Voluntary trial extension: Participants in whom the primary outcome has been achieved at week 6 will be invited to participate in an optional (completely voluntary) extension of the trial and continue their assigned treatment for an additional six weeks. This will allow for exploratory assessment of longer-term efficacy of the fibres (primary and secondary outcomes assessed again at week 12). Apart from the planned study, if a clinical decision is made by the patient and physician to perform sigmoidoscopy or colonoscopy (which is justified in many cases), bio samples and data from these procedures will be collected if patients agree. The procedure will not be a research procedure, but the patients will be approached and consented for bio sample collection. The optional extension will advantageously provide further biological insights into the effects of the fibres and can inform future intervention studies.
- Conditions
- Ulcerative Colitis
- Being tested
- Acacia Gum, Microcrystalline Cellulose, Placebo
- Keywords
- inflammatory bowel disease, ulcerative colitis, dietary fibre, gut microbiome
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acacia GumDietary supplement
Also called AGRI-SPRAY ACACIA® R, Agrigum International
Participants (n=23) incorporate the fibre supplement into their usual diet daily.
Microcrystalline CelluloseDietary supplement
Also called MICROCEL® MC-12, ROQUETTE
Participants (n=23) incorporate the fibre supplement into their usual diet daily.
PlaceboDietary supplement
Also called GLUCIDEX® IT 19 - MALTODEXTRIN, ROQUETTE
Participants (n=23) incorporate the placebo into their usual diet daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 3 and Week 6 (and week 12, if applicable)
Secondary outcomes (17)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Week 3 and Week 6 (and week 12, if applicable)
Changes in fecal pH
Fecal pH will be measured using a pH meter.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Week 3 and Week 6 (and week 12, if applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start3 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eytan Wine, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515210
- Sponsor's protocol ID
- Pro00137948
- Acronym
- PAIF-UC
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared that underlies the results reported after deidentification (text, tables, figures, and appendices). Data will be made available through a safe and secure publicly available data sharing repository.
Publications
Crohn's and Colitis Canada. Impact of inflammatory bowel disease in Canada. Available from: https://crohnsandcolitisca/About-Us/Resources-Publications/Impact-of-IBD-Report2023.
Kayal M, Shah S. Ulcerative Colitis: Current and Emerging Treatment Strategies. J Clin Med. 2019 Dec 30;9(1):94. doi: 10.3390/jcm9010094.
PubMed 31905945Michail 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.
PubMed 22170749Nagao-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.
PubMed 27795980Britton 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.
PubMed 30650377Di 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.
PubMed 36432460Limketkai 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.
PubMed 31819987So 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.
PubMed 29757343Parada 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.
PubMed 30915065Levine 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.
PubMed 29777041Desai 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.
PubMed 27863247Earle 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.
PubMed 26439864Gill 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.
PubMed 33208922
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profiling of Anti-inflammatory Fibre Supplements in Patients With Ulcerative Colitis: Towards Personalized Complementary Strategies.
- ClinicalTrials.gov ID
- NCT06515210
- Acronym / sponsor ID
- PAIF-UC / Pro00137948
- Conditions
- Ulcerative Colitis
- Keywords
- inflammatory bowel disease, ulcerative colitis, dietary fibre, gut microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prevalence and incidence of inflammatory bowel diseases (IBD), including ulcerative colitis (UC), is rising rapidly in Canada and the rates are amongst the highest globally (Crohn's and Colitis Canada, 2023). UC is a chronic disease characterized by colonic inflammation, often inadequately managed in the long-term with immunosuppressive medications that can increase risk of infections and malignancies (Kayal \& Shah, 2019). Alternative, complementary strategies are, therefore, necessary to improve patient outcomes.
A potential target for such strategies may be the gut microbiome, which can predict failure of standard therapy in pediatric UC (Michail et al., 2012). Putative, pro-inflammatory microbes are enriched in patients with IBD compared to healthy controls and disease phenotypes can be transferred via microbiome transplantation into germ-free mice (Nagao-Kitamoto et al., 2016; Birtton et al., 2019), suggesting a causal role of the gut microbiome in IBD. Fibre-based treatments for UC have been proposed and tested for UC but results are mixed, quite modest in many cases, and many gaps remain in defining the most appropriate clinical approach (Di Rosa et al., 2022; Limketkai et al, 2020).
Dietary fibre has great potential as a safe, complementary, microbiome-targeted treatment strategy to reduce inflammation in UC. Food supplementation with fermentable fibres alters microbiome composition (So et al., 2018) and increases microbial production of bioactive metabolites like short-chain fatty acids (SCFAs) that can attenuate inflammation (Parada Venegas et al., 2019; Levine et al., 2018). Provision of growth substrates in the form of fibre also enhances gut barrier function by decreasing mucus degradation, thus reducing bacterial encroachment and immune activation that may drive inflammation (Desai et al., 2016; Earle et al., 2015). However, specific fibre structures elicit distinct health effects due to differences in physicochemical properties (Gill et al., 2020). Therefore, important open questions remain, such as which fibres and physicochemical properties are most beneficial in the context of UC, and are their effects microbiome-dependent?
Hypothesis: Acacia gum (AG; soluble and fermentable fibre) and microcrystalline cellulose (MCC; insoluble and non-fermentable fibre) will decrease gut inflammation in patients with UC, but through different mechanisms given their differences in fermentability.
The overall goal of this study is to determine the clinical effects of AG and MCC in patients with UC, using normalization of FCP as the primary outcome.
Voluntary trial extension: Participants in whom the primary outcome has been achieved at week 6 will be invited to participate in an optional (completely voluntary) extension of the trial and continue their assigned treatment for an additional six weeks. This will allow for exploratory assessment of longer-term efficacy of the fibres (primary and secondary outcomes assessed again at week 12). Apart from the planned study, if a clinical decision is made by the patient and physician to perform sigmoidoscopy or colonoscopy (which is justified in many cases), bio samples and data from these procedures will be collected if patients agree. The procedure will not be a research procedure, but the patients will be approached and consented for bio sample collection. The optional extension will advantageously provide further biological insights into the effects of the fibres and can inform future intervention studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acacia Gum | Experimental | Dietary Supplement: Acacia GumAcacia 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. |
| Microcrystalline Cellulose | Experimental | Dietary Supplement: Microcrystalline CelluloseMicrocrystalline 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. |
| Maltodextrin | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acacia GumAlso: AGRI-SPRAY ACACIA® R, Agrigum InternationalParticipants (n=23) incorporate the fibre supplement into their usual diet daily. | Dietary supplement | Acacia Gum |
| Microcrystalline CelluloseAlso: MICROCEL® MC-12, ROQUETTEParticipants (n=23) incorporate the fibre supplement into their usual diet daily. | Dietary supplement | Microcrystalline Cellulose |
| PlaceboAlso: GLUCIDEX® IT 19 - MALTODEXTRIN, ROQUETTEParticipants (n=23) incorporate the placebo into their usual diet daily. | Dietary supplement | Maltodextrin |
Primary outcome
Changes in fecal calprotectin
Time frame: Week 3 and Week 6 (and week 12, if applicable)
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.
17 secondary outcomes
Changes in disease activity
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in fecal microbiome composition
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in function of the fecal microbiome
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in gut barrier function: fecal zonulin
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in gut barrier function: plasma lipopolysaccharide binding protein
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in fecal short-chain fatty acids
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in fecal bile acids
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in fecal pH
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in fecal dry mass percentage
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in the plasma metabolome
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in the plasma inflammatory cytokines
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in routine clinical bloodwork
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in body weight
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in gastrointestinal symptoms
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in dietary intake
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Changes in patient quality of life
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Need for rescue therapy
Time frame: Week 3 and Week 6 (and week 12, if applicable)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- BackgroundCrohn's and Colitis Canada. Impact of inflammatory bowel disease in Canada. Available from: https://crohnsandcolitisca/About-Us/Resources-Publications/Impact-of-IBD-Report2023.
- Background: PubMed 31905945Kayal M, Shah S. Ulcerative Colitis: Current and Emerging Treatment Strategies. J Clin Med. 2019 Dec 30;9(1):94. doi: 10.3390/jcm9010094.
- Background: PubMed 22170749Michail 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.
- Background: PubMed 27795980Nagao-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.
- Background: PubMed 30650377Britton 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.
- Background: PubMed 36432460Di 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.
- Background: PubMed 31819987Limketkai 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.
- Background: PubMed 29757343So 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.
- Background: PubMed 30915065Parada 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.
- Background: PubMed 29777041Levine 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.
- Background: PubMed 27863247Desai 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.
- Background: PubMed 26439864Earle 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.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared that underlies the results reported after deidentification (text, tables, figures, and appendices). Data will be made available through a safe and secure publicly available data sharing repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anissa Armet, PhD, RD contact
Eytan Wine, MD, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acacia Gum and Microcrystalline Cellulose in people with Ulcerative Colitis, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eytan Wine, MD, PhD ((780) 248-5494, wine@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fecal calprotectin (time frame: Week 3 and Week 6 (and week 12, if applicable)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515210, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.