[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538259":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":48,"studyPopulation":48,"armGroups":59,"interventions":72,"overallOfficials":48,"centralContacts":82,"locations":92,"responsibleParty":127,"collaborators":48,"id":129,"slug":48,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":48,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":48,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":48,"overallStatus":95,"whyStopped":48,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Nutricia UK Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Growth","At Baseline (Day 1), End of Intervention (Day 31), and Follow-Up (Day 87) assessments, length and head circumference will be measured using standard measures to the nearest 0.1cm. Body weight (kg) will also be measured, where possible, by the investigating Dietitian\u002Frelevant HCP using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. These measures will be used to calculate z-scores (i.e., weight-for-length, weight, length, and head circumference; based on UK-WHO 2006 growth reference data for children 0-4 years old) and plotted on growth charts for centile measurement.","Baseline to three months",[14,17,20,23,26,29,32,35,38,41,44],{"measure":15,"description":16,"timeFrame":12},"Gastrointestinal Tolerance","Gastrointestinal tolerance will be recorded by the parent\u002Fcarer at Baseline Assessment and Baseline Days 1-3, where this period is undertaken by the patient), during the Intervention Period on Days 10, 17, 24, and 29-31, and during the 2-month Follow-Up period on Days 85-87. Tolerance will be recorded using a standardised GI tolerance questionnaire.",{"measure":18,"description":19,"timeFrame":12},"Stool frequency and consistency","Stool frequency and consistency (Brussels Infant and Toddler Stool Scale) will be recorded by the parent\u002Fcarer at Baseline on Days 1-3 (where applicable), as well as on during the Intervention Period on Days 10, 17, 24, and 29-31, and during the 2-month Follow-Up on Days 85-87.",{"measure":21,"description":22,"timeFrame":12},"Study Product Intake","Intake of study product will be assessed daily throughout the Baseline and Intervention Periods by the parent\u002Fcarer by recording how much feed was consumed. During the 2-month Follow-Up, intake of study product will be assessed for 3 days (Days 84-87). The daily minimum target intake amount prescribed by the investigating Dietitian\u002Frelevant HCP will be recorded at the start of the study, and any changes to this prescription will be noted.",{"measure":24,"description":25,"timeFrame":12},"Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD)","A self-evaluation tool will be completed by the parent\u002Fcarer on the day of the Baseline Assessment (Day 1), on Days 10 and 31 during the Intervention Period, and on Day 87 during the 2-month Follow-Up to give an indication of severity of atopic dermatitis (where present). This will involve tick box questions and a diagram of an infant for the parent\u002Fcarer to highlight presence of dermatitis.",{"measure":27,"description":28,"timeFrame":12},"Patient Reported Atopic Symptoms","The parent\u002Fcarer will be asked to indicate their perception of the presence and severity of several common atopic symptoms for their child (wheezing, itchy\u002Fwatery eyes, crying frequency, sneezing\u002Frunny\u002Fblocked nose, sleep quality) via 100mm visual analogue scales, with 100mm indicating more severe symptoms. These will be recorded on at Baseline Assessment (Day 1), on Day 3, Days 10, 17, 24, and 31 during the Intervention Period, and on Day 87 during the Follow-Up Period.",{"measure":30,"description":31,"timeFrame":12},"Cow's Milk Related Symptom Score","Infants' stool pattern, the presence and intensity of crying and regurgitation, as well as skin and respiratory manifestations will be assessed via the CoMiSS™ tool by the investigating Dietitian\u002Frelevant HCP at the Baseline (Day 1), End of Intervention (Day 31), and Follow-Up (Day 87) Assessments. Total scores range from 0-33, with higher number indicating more severe symptoms of cow's milk allergy.",{"measure":33,"description":34,"timeFrame":12},"Food Allergy Quality of Life-Parental Burden (FAQL-PB)","Parental measures of QOL (related to their child's allergy) will be assessed via a standardised validated questionnaire on the day of the Baseline Assessment (Day 1), on the final day of the Intervention Period (Day 31), and at the end of the Follow-Up Period (Day 87).",{"measure":36,"description":37,"timeFrame":12},"Acceptability of the Study Formula","Feed acceptability (e.g., ease of use, liking) will be assessed at Baseline (Day 3, where applicable), during the Intervention Period on Days 10 and 31, and at the end of the Follow-Up period on Day 87, via a Likert-style questionnaire completed by the parent\u002Fcarer (strongly disagree\u002Fdisagree\u002Fdon't know\u002Fagree\u002Fstrongly agree)",{"measure":39,"description":40,"timeFrame":12},"Nutrient Intake (Energy, Protein, Micronutrients)","Nutrient intake, including intake of all nutrition provided (including the study product, any other enteral feeding, foods, drinks etc.) will be recorded via a 24hr dietary recall conducted by the investigating Dietitian\u002Frelevant HCP at the Baseline (Day 1), Day 10, End of Intervention (Day 31), and Follow-Up (Day 87) Assessments. Dietary data will be inputted by the study team into nutritional software to estimate energy and macro- and micronutrient intakes.",{"measure":42,"description":43,"timeFrame":12},"Dietetic Goal","A dietetic goal (e.g., improve tolerance, reduce atopic symptoms, maintain symptom control, maintain normal growth) will be set by the investigating Dietitian\u002Frelevant HCP at the Baseline Assessment (Day 1) for each infant. At the End of Intervention Assessment (Day 31), the investigating Dietitian\u002Frelevant HCP will assess and note if the dietetic goal was met (yes\u002Fno) and will set a dietetic goal for the Follow-Up Period. At the Follow-Up Assessment (Day 87), the investigating Dietitian\u002Frelevant HCP will assess and note if the dietetic goal was met (yes\u002Fno).",{"measure":45,"description":46,"timeFrame":47},"Overall Safety","All adverse events will be recorded throughout the study.","Through study completion, an average of three months",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":55},"TRIPLE",[56,57,58],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[60,66],{"label":61,"type":62,"description":63,"interventionNames":64},"Intervention","EXPERIMENTAL","Hydrolysed rice protein formula",[65],"Other: Hydrolysed Rice Protein Formula",{"label":67,"type":68,"description":69,"interventionNames":70},"Control","ACTIVE_COMPARATOR","Cow's milk based extensively hydrolysed formula",[71],"Other: Cow's Milk Based Extensively Hydrolysed Formula",[73,78],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":48},"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.",[61],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":48},"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.",[67],[83,88],{"name":84,"role":85,"phone":86,"phoneExt":48,"email":87},"Isabel Evans, MSc","CONTACT","07385000738","Isabel.EVANS@danone.com",{"name":89,"role":85,"phone":90,"phoneExt":48,"email":91},"Gary P Hubbard, PhD","07738024720","gary.hubbard@nutricia.com",[93,112],{"facility":94,"status":95,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Gloucestershire Royal NHS Trust","RECRUITING","Gloucester","Gloucestershire","GL1 3NN","United Kingdom","UK",{"type":102,"coordinates":103},"Point",[104,105],-2.2431,51.86568,{"lat":105,"lon":104},[108],{"name":109,"role":85,"phone":110,"phoneExt":48,"email":111},"Victoria Bittle","0300 422 5506","v.bittle@nhs.net",{"facility":113,"status":95,"city":114,"state":115,"zip":116,"country":99,"countryCode":100,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Bristol Royal Hospital for Children","Bristol","Somerset","BS16 1TA",{"type":102,"coordinates":118},[119,120],-2.59665,51.45523,{"lat":120,"lon":119},[123],{"name":124,"role":85,"phone":125,"phoneExt":48,"email":126},"Sarah Trace","0117 3428802","sarah.trace@uhbw.nhs.uk",{"type":128,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","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":139,"type":140},86,"ESTIMATED","INTERVENTIONAL",[143],"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.",[146],"Cow's Milk Protein Allergy","2026-04-09",{"date":149,"type":150},"2026-04-13","ACTUAL",{"date":152,"type":150},"2024-02-01",{"date":154,"type":140},"2027-07",{"name":5,"class":6},2]