[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518806":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":38,"studyPopulation":31,"armGroups":39,"interventions":50,"overallOfficials":54,"centralContacts":59,"locations":65,"responsibleParty":76,"collaborators":31,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":31,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":31,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":68,"whyStopped":31,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Mahidol University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Short term unresponsiveness rate","Short term unresponsiveness rate between once daily dose and four times\u002Fweek dose .during maintenance phase of wheat OIT.\n\nShort term unresponsiveness means patients who pass the oral food challenge test after stopping oral immunotherapy for a short period","13 months",[14,16,18,21,25,28],{"measure":15,"description":15,"timeFrame":12},"Specific IgE to wheat",{"measure":17,"description":17,"timeFrame":12},"Specific IgG4 to wheat",{"measure":19,"description":20,"timeFrame":12},"Changing in Body weight","Changing in Body weight in kilograms",{"measure":22,"description":23,"timeFrame":24},"Compliance","Compliance of wheat ingestion (group A: every day, groupB: 4 days\u002Fweeks). Compliance can be calculated by dividing the number of days on which wheat is actually ingested by the total number of days prescribed for wheat consumption.","12 months",{"measure":26,"description":27,"timeFrame":12},"Adverse reactions","Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system",{"measure":29,"description":30,"timeFrame":12},"Quality of life by using FAQLQ-PF","Quality of life before and after enrollment by using FAQLQ-PF",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE","All subject in this study were patients with history of IgE mediated wheat allergy and positive OFC test. All of them received wheat OIT and reached target maintenance dose of wheat OIT.\n\nThe primary outcome was to compare short term unresponsiveness rate between once daily dose and four times\u002Fweek dose during one year maintenance phase of wheat OIT. Other outcomes were collected during the projected such as blood and skin examination for immunologic parameter, changing in Body weight, WA, WH and BMI, compliance, adverse reactions, rates of medication used during OIT and quality of life",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Four per week","EXPERIMENTAL","Case wheat allergy that on four times\u002Fweek dose during one year maintenance phase of wheat OIT",[45],"Other: Wheat (Four times per week)",{"label":47,"type":48,"description":49,"interventionNames":31},"Once daily","NO_INTERVENTION","Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT",[51],{"type":6,"name":52,"description":43,"armGroupLabels":53,"otherNames":31},"Wheat (Four times per week)",[41],[55],{"name":56,"affiliation":57,"role":58},"Punchama Pacharn, MD","Mahidol University, Siriraj Hospital,Thailand","PRINCIPAL_INVESTIGATOR",[60],{"name":56,"role":61,"phone":62,"phoneExt":63,"email":64},"CONTACT","024197000","5670","punchama@gmail.com",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":31,"geoPoint":31,"contacts":74},"Siriraj Hospital","RECRUITING","Bangkoknoi","Bangkok","10700","Thailand","TH",[75],{"name":56,"role":61,"phone":31,"phoneExt":31,"email":31},{"type":77,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100518806","comparison-efficacy-between-two-different-frequency-of-maintenance-dose-oral-immunotherapy-100518806",false,"NCT06035328","Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy","Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy","Inclusion Criteria:\n\n* Age 5-18 years old\n* Children aged 5-18 years with history of IgE mediated wheat allergy and positive OFC test\n* Reach target maintenance dose of wheat OIT and ongoing to maintenance phase of wheat OIT\n\nExclusion Criteria:\n\n* Patient with low dose OIT protocol\n* Patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic disease;\n* Patients who had been treated with some other immunotherapy (eg, SLIT, another OIT) or biologic therapy (eg, Omalizumab)\n* Patients with a developmental problem or mental disorder\n* Active eosinophilic gastrointestinal disease in the past 2 years\n* Use of b-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium-channel blockers\n* Pregnancy or lactation\n* Patient who could not visit clinic as protocol","ALL","5 Years","18 Years",{"count":89,"type":90},64,"ESTIMATED","INTERVENTIONAL",[93],"NA","Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not standardized, and a wide heterogeneity exists in the literature . So the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times\u002Fweek dose during one year maintenance phase of wheat OIT",[96,97],"Wheat Hypersensitivity","Immunotherapy",[96,97,99],"Short term unresponsiveness","2025-05-06",{"date":102,"type":103},"2025-05-09","ACTUAL",{"date":105,"type":103},"2023-07-01",{"date":107,"type":90},"2027-03-22",{"name":5,"class":6},1]