[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100451485":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":29,"locations":24,"responsibleParty":35,"collaborators":37,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":24,"eligibilityCriteria":45,"healthyVolunteers":42,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":24,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":24,"overallStatus":62,"whyStopped":24,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":24},{"fullName":5,"class":6},"Lovisenberg Diakonale Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-FODMAP diet","ACTIVE_COMPARATOR","Patients with IBS on a 4-week low-FODMAP diet.",[13],"Other: Low-FODMAP diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Starch- and Sucrose Reduced Diet","EXPERIMENTAL","Patients with IBS on a s 4-week Starch- and Sucrose Reduced Diet (SSRD).",[19],"Other: Starch- and Sucrose Reduced Diet (SSRD)",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"4 weeks of a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs)",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Starch- and Sucrose Reduced Diet (SSRD)","4 weeks of a diet low in starch and sucrose",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Jørgen Valeur, PhD","CONTACT","0047 23225140","jorgen.valeur@lds.no",{"type":36,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[38],{"name":39,"class":6},"University of Bergen","100451485","sucrase-isomaltase-deficiency-as-a-cause-of-irritable-bowel-syndrome-100451485",false,"NCT05159115","Sucrase-isomaltase Deficiency as a Cause of Irritable Bowel Syndrome","Validation of the 13C-labelled breath test to diagnose sucrase-isomaltase deficiency (n=40)\n\nInclusion Criteria:\n\n* Signed informed consent\n* BMI 18-30 kg\u002Fm2\n* Referred for gastroscopic examination with suspected GI disorder\n\nExclusion Criteria:\n\n• Unwilling or not capable of signing the informed consent\n\nSucrase-isomaltase deficiency as a cause of symptoms in patients with irritable bowel syndrome (n=80)\n\nInclusion Criteria:\n\n* Signed informed consent\n* BMI 18-30 kg\u002Fm2\n* IBS diagnosis according to Rome IV criteria\n\nExclusion Criteria:\n\n* Inflammatory bowel disease, celiac disease or diabetes mellitus\n* Chronic immune diseases affecting the GI-system\n* Unwilling\u002Funable to maintain a stable diet throughout the study period\n* Use of antibiotic treatment for the last 4 weeks\n* Currently on a restrictive diet","ALL","18 Years","90 Years",{"count":50,"type":51},80,"ESTIMATED","INTERVENTIONAL",[54],"NA","Irritable bowel syndrome (IBS) is a functional disorder causing troublesome symptoms and reduced quality of life. It affects 10-20% of the population, hence creates large costs for society. About 30-40% of all IBS patients do not benefit from current treatment options. Sucrase-isomaltase (SI) deficiency is an unexplored condition, that may explain symptoms in IBS patients who experience no effect from today's treatments. Currently, a duodenal biopsy is the gold standard for the diagnosis of SI deficiency, however the condition is not well investigated. A 13C-labelled breath test holds promise as a non-invasive alternative, but it has not previously been validated.\n\nThis project will address the knowledge gap related to a possible association between SI deficiency and IBS by addressing two research questions that have never been answered before. We aim to:\n\n1. Validate the 13C-labelled breath test as a diagnostic tool by assessing the strength of the association between the breath test and SI activity measured in duodenal biopsies\n2. Use the 13C-labelled breath test in a randomized dietary crossover trial comparing a starch and sucrose reduced diet (SSRD) with the standard low-FODMAP diet in IBS patients, to evaluate whether SI activity is associated with dietary changes according to symptom severity and gut microbiota composition",[57,58,59,60,61],"Irritable Bowel Syndrome","Sucrose Intolerance Due to Sucrase-Isomaltase Deficiency","Carbohydrate; Malabsorption","Sucrase Isomaltase Deficiency","Functional Gastrointestinal Disorders","NOT_YET_RECRUITING","2022-01-18",{"date":65,"type":66},"2022-02-02","ACTUAL",{"date":68,"type":51},"2022-03-14",{"date":70,"type":51},"2027-12-31",{"name":5,"class":6}]