[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490552":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":56,"collaborators":58,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":25,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Onze Lieve Vrouwe Gasthuis","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group (immune-supportive diet)","EXPERIMENTAL","* Immune-supportive diet (for 4 months) on top of peanut and\u002For nut free diet. Foods are allocated into 3 food groups:\n\n  1. Recommended in ample amounts: with an acknowledged beneficial role in immune health (first choice foods);\n  2. Recommended in limited amounts: with an acknowledged beneficial role in immune health when used in limited amounts (second choice foods).\n  3. Not recommended: with an acknowledged unfavourable role in immune health (third choice foods)\n* Self-assessed feasibility and adherence to the Immune-supportive diet (intervention group only) a by Likert scale after 2,5 and 4 months of dietary intervention;\n* Dietary adherence will be determined by the researchers after 4 months by calculating the number of first and second choice foods based on the food diaries after dietary intervention.",[13],"Other: Immune-supportive diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","\\- Peanut and\u002For nut free diet only",[19],"Other: Standard care",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Immune-supportive diet","The intervention includes a immune-supportive diet over a period of 4 months",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard care","Standard care: Peanut or nut free diet",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Berber Vlieg-Boerstra","CONTACT","+31620965612","b.vlieg-boerstra@olvg.nl",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Chantal den Elzen, MSc","+31627538421","c.denelzen@olvg.nl",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"OLVG","RECRUITING","Amsterdam","Netherlands","NL",{"type":48,"coordinates":49},"Point",[50,51],4.88969,52.37403,{"lat":51,"lon":50},[54],{"name":55,"role":33,"phone":25,"phoneExt":25,"email":25},"Loes Pronk, PhD",{"type":57,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[59,62,64,66,68,70,72,74,76,78],{"name":60,"class":61},"Ekhaga foundation","UNKNOWN",{"name":63,"class":6},"Rijnstate Hospital",{"name":65,"class":6},"Noordwest Ziekenhuisgroep",{"name":67,"class":6},"Erasmus Medical Center",{"name":69,"class":6},"Wageningen University",{"name":71,"class":6},"Amsterdam UMC",{"name":73,"class":6},"Utrecht Institute for Pharmaceutical Sciences",{"name":75,"class":6},"Diakonessenhuis, Utrecht",{"name":77,"class":6},"Deventer Ziekenhuis",{"name":79,"class":6},"Harvard University","100490552","immune-supportive-diet-and-gut-permeability-in-allergic-children-100490552",false,"NCT05667610","Immune-supportive Diet and Gut Permeability in Allergic Children","Effect of an Immune-supportive Diet on Gut Permeability and Allergic Symptoms in Children With Peanut and\u002For Nut Allergy","DIAMETER","Inclusion Criteria:\n\n* Children of 3 to 17 years of age with a positive open or double-blind placebo-controlled peanut or nut challenge \\\u003C 12 months to inclusion OR an obvious and objective IgE-mediated allergic reaction following the consumption of isolated peanut or nut within 1 hours, confirmed by sensitisation to peanut or nut \\\u003C 24 months to inclusion;\n* Children who are potty trained or house trained;\n* Presence of IgE to peanut ≥0.35 kilo units per liter (kU\u002Fl) or skin prick test \\> 3 mm to peanut or nut, \\\u003C 12 months prior to challenge.\n\nExclusion Criteria:\n\n* Only mild symptoms in the oral cavity to peanut or nut due to pollen food syndrome;\n* A negative peanut or nut challenge;\n* Children who are not potty trained (house trained);\n* Gastro-intestinal diseases (e.g. Morbus Crohn, coeliac disease, Colitis Ulcerosa), lactose intolerance\n* severe cow's milk allergy -because of possible traces of cow's milk in lactose in the SAT), syndromes, infectious\u002Fimmunology diseases other than atopy, or diabetes;\n* Laxative treatment, such as lactulose;\n* Not able to read or write Dutch.",true,"ALL","3 Years","17 Years",{"count":93,"type":94},132,"ESTIMATED","INTERVENTIONAL",[97],"NA","Peanut and nut allergy can be life threatening. Some patients have very low threshold levels (i.e. the amounts of peanut and nuts to which the patients react), others react to higher doses. The reasons for these differences in threshold are not well understood. Patients with peanut and nut allergy often suffer from other allergic diseases (atopic dermatitis, hay fever and asthma). A disturbed gut microbiota composition and an increased gut permeability may explain the development of allergic disease. We hypothesize that increased gut permeability is related to low threshold levels to peanuts or nuts. In addition, as it is known that nutrition can influence our gut permeability, we also hypothesize that a healthful immune-supportive diet restores gut permeability and alleviates symptoms.\n\nTherefore, the purpose of the study is to study in peanut and nut allergic children:\n\n1. the relationship between gut permeability and threshold levels to peanut or nuts;\n2. the effect of an immune-supportive diet on gut permeability, gut microbiome composition, coexisting allergic symptoms and quality of life",[100,101],"Peanut Allergy","Nut Allergy",[103,22,104],"Gut permeability","Thresholds","2025-04-28",{"date":107,"type":108},"2025-05-01","ACTUAL",{"date":110,"type":108},"2022-09-08",{"date":112,"type":94},"2027-06-30",{"name":5,"class":6},1]