[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538259":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":76,"collaborators":26,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":26,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Nutricia UK Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Hydrolysed rice protein formula",[13],"Other: Hydrolysed Rice Protein Formula",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Cow's milk based extensively hydrolysed formula",[19],"Other: Cow's Milk Based Extensively Hydrolysed Formula",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"OTHER","Hydrolysed Rice Protein Formula","Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Cow's Milk Based Extensively Hydrolysed Formula","Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Isabel Evans, MSc","CONTACT","07385000738","Isabel.EVANS@danone.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Gary P Hubbard, PhD","07738024720","gary.hubbard@nutricia.com",[42,61],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Gloucestershire Royal NHS Trust","RECRUITING","Gloucester","Gloucestershire","GL1 3NN","United Kingdom","UK",{"type":51,"coordinates":52},"Point",[53,54],-2.2431,51.86568,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":59,"phoneExt":26,"email":60},"Victoria Bittle","0300 422 5506","v.bittle@nhs.net",{"facility":62,"status":44,"city":63,"state":64,"zip":65,"country":48,"countryCode":49,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Bristol Royal Hospital for Children","Bristol","Somerset","BS16 1TA",{"type":51,"coordinates":67},[68,69],-2.59665,51.45523,{"lat":69,"lon":68},[72],{"name":73,"role":34,"phone":74,"phoneExt":26,"email":75},"Sarah Trace","0117 3428802","sarah.trace@uhbw.nhs.uk",{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100538259","hydrolysed-rice-formula-study-100538259",false,"NCT06288503","Hydrolysed Rice Formula Study","A Double-blind, Randomised-controlled Trial Evaluating a Hydrolysed Rice Formula Compared to a Cow's Milk Protein-based Extensively Hydrolysed Formula in Infants With Cow's Milk Allergy","Inclusion Criteria:\n\n* Male or female\n* Aged 0-13 months\n* Presenting to primary or secondary care with symptoms\u002Fclinical history suggestive of CMA\n* Will receive at least 30% of energy requirements from the study formula\n* Written informed consent from parent\u002Fcarer\n\nExclusion Criteria:\n\n* Severe CMA (including anaphylaxis) and\u002For requiring an AAF\n* Faltering growth (based on NICE guidelines36 - Appendix 1)\n* Previous allergy to any study product ingredients (including whey hydrolysate and\u002For rice)\n* Primary lactose intolerance\n* Food Protein-Induced Enterocolitis Syndrome (FPIES)\n* Exclusively breast fed\n* Severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes\n* Severe hepatic or renal insufficiency\n* Premature infants (born \\\u003C37 weeks) with a corrected age of \\\u003C4 weeks\n* Requirement for any parenteral nutrition\n* Participation in other clinical intervention studies within 1 month of recruitment\n* Concern around the willingness\u002Fability of the caregiver to comply with the study protocol and\u002For study requirements","ALL","0 Months","13 Months",{"count":89,"type":90},86,"ESTIMATED","INTERVENTIONAL",[93],"NA","This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms\u002Fclinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety.",[96],"Cow's Milk Protein Allergy","2026-04-09",{"date":99,"type":100},"2026-04-13","ACTUAL",{"date":102,"type":100},"2024-02-01",{"date":104,"type":90},"2027-07",{"name":5,"class":6},2]