[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555678":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":42,"centralContacts":46,"locations":55,"responsibleParty":75,"collaborators":50,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":50,"enrollmentInfo":87,"targetDuration":50,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":58,"whyStopped":50,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Alberta","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Acacia Gum","EXPERIMENTAL","Acacia gum is a dietary fibre with low-viscosity and is fermentable.\n\nFemale 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.\n\nMale 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.\n\nThose participants who voluntarily extend their treatment for an additional six weeks will continue with consuming the full dose daily.",[13],"Dietary Supplement: Acacia Gum",{"label":15,"type":10,"description":16,"interventionNames":17},"Microcrystalline Cellulose","Microcrystalline cellulose is a dietary fibre that is non-viscous and and non-fermentable.\n\nFemale 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.\n\nMale 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.\n\nThose participants who voluntarily extend their treatment for an additional six weeks will continue with consuming the full dose daily.",[18],"Dietary Supplement: Microcrystalline Cellulose",{"label":20,"type":21,"description":22,"interventionNames":23},"Maltodextrin","PLACEBO_COMPARATOR","Maltodextrin is a digestible carbohydrate. It is provided in isocaloric doses to the dietary fibres.\n\nFemale 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.\n\nMale 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.",[24],"Dietary Supplement: Placebo",[26,32,36],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Participants (n=23) incorporate the fibre supplement into their usual diet daily.",[9],[31],"AGRI-SPRAY ACACIA® R, Agrigum International",{"type":27,"name":15,"description":28,"armGroupLabels":33,"otherNames":34},[15],[35],"MICROCEL® MC-12, ROQUETTE",{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Placebo","Participants (n=23) incorporate the placebo into their usual diet daily.",[20],[41],"GLUCIDEX® IT 19 - MALTODEXTRIN, ROQUETTE",[43],{"name":44,"affiliation":5,"role":45},"Eytan Wine, MD, PhD","PRINCIPAL_INVESTIGATOR",[47,52],{"name":44,"role":48,"phone":49,"phoneExt":50,"email":51},"CONTACT","(780) 248-5494",null,"wine@ualberta.ca",{"name":53,"role":48,"phone":50,"phoneExt":50,"email":54},"Anissa Armet, PhD, RD","aarmet@ualberta.ca",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"University of Alberta Hospital","RECRUITING","Edmonton","Alberta","T6G 2X8","Canada","CA",{"type":65,"coordinates":66},"Point",[67,68],-113.46871,53.55014,{"lat":68,"lon":67},[71,73,74],{"name":44,"role":48,"phone":72,"phoneExt":50,"email":51},"780-492-2223",{"name":53,"role":48,"phone":50,"phoneExt":50,"email":54},{"name":44,"role":45,"phone":50,"phoneExt":50,"email":50},{"type":76,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100555678","personalized-anti-inflammatory-fibres-in-ulcerative-colitis-100555678",false,"NCT06515210","Personalized Anti-Inflammatory Fibres in Ulcerative Colitis","Clinical Profiling of Anti-inflammatory Fibre Supplements in Patients With Ulcerative Colitis: Towards Personalized Complementary Strategies.","PAIF-UC","Inclusion Criteria:\n\n* Known diagnosis of ulcerative colitis.\n* Evidence of active disease, defined as either 1) measured FCP \\>100 µg\u002Fg 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 \\\u003C2 or PUCAI \\\u003C10) that have active inflammation (elevated FCP \\>100 µg\u002Fg) would also be eligible, as will patients with active symptoms, regardless of availability of FCP.\n* Tanner stage ≥4 for pediatric patients.\n* Weight \\>40kg.\n* 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\u002Fgeneric treatment).\n* Men and women that use adequate contraceptive methods.\n* Able to maintain current lifestyle (diet, exercise, supplements\u002Fmedications, and sleep) throughout study.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Presence of Crohn disease, IBD unclassified, non-IBD bowel conditions (e.g., celiac), or motility disorder.\n* Presence of abnormal constrictions of the gastrointestinal tract, diseases of the esophagus and\u002For 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.\n* 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.\n* Presence of serious infection (e.g., infectious colitis).\n* Presence of severe anemia, defined as hemoglobin \\\u003C100 g\u002FL or considered clinically significant based on physician discretion.\n* Presence of disease or condition that negatively impacts ability to swallow, which may interfere with intake of supplement.\n* Use of systemic antibiotics for more than a week during two months prior to intervention, or any antibiotic use during the intervention.\n* Use of medications that inhibit peristaltic movement (e.g. opioids, loperamide)\n* 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).\n* 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).\n* Chronic use of laxatives, stool softeners, or anti-diarrheal medications.\n* Chronic use of illicit drugs and\u002For excessive alcohol (e.g., average of \\>7 drinks\u002Fweek).\n* Current smoker (cigarettes).\n* History of abdominal surgery, including appendectomy.\n* Pregnancy or intention of the patient to become pregnant during the study period.\n* Breastfeeding.\n* Allergy to any ingredients of investigational products or placebo (i.e., acacia gum, microcrystalline cellulose, or maltodextrin).\n* Unable to maintain high fiber intake through supplementation during intervention.","ALL","14 Years",{"count":88,"type":89},69,"ESTIMATED","INTERVENTIONAL",[92],"NA","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)?\n\nResearchers 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.\n\nParticipants 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.",[95],"Ulcerative Colitis",[97,98,99,100],"inflammatory bowel disease","ulcerative colitis","dietary fibre","gut microbiome","2026-06-03",{"date":103,"type":104},"2026-06-05","ACTUAL",{"date":106,"type":104},"2025-06-03",{"date":108,"type":89},"2027-12",{"name":5,"class":6},1]