[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100389996":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":88,"studyPopulation":76,"armGroups":89,"interventions":102,"overallOfficials":76,"centralContacts":112,"locations":121,"responsibleParty":248,"collaborators":250,"id":253,"slug":76,"hasResults":254,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":254,"sex":260,"minAge":261,"maxAge":262,"enrollmentInfo":263,"targetDuration":76,"studyType":266,"phases":267,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":136,"whyStopped":76,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":283},{"fullName":5,"class":6},"United Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":76},[9],{"measure":10,"description":11,"timeFrame":12},"Frequency of regurgitation","Decrease of the daily number of regurgitation between baseline and day 14","Day 14",[14,18,22,25,28,31,34,37,40,43,46,49,52,55,58,61,64,67,70,73],{"measure":15,"description":16,"timeFrame":17},"Frequency of regurgitations","Change in the daily number of regurgitation between baseline and day 30 \u002F day 90","Day 30, Day 90",{"measure":19,"description":20,"timeFrame":21},"Severity of regurgitation episodes","Severity of regurgitations will be assessed using the adapted Vandenplas' score (range: 0 to 6; higher scores indicate more severe regurgitation)","Day 14, Day 30, Day 90",{"measure":23,"description":24,"timeFrame":21},"Stools' frequency","Average daily stool's number",{"measure":26,"description":27,"timeFrame":21},"Stools' consistency","The Amsterdam Infant Stool Scale (AISS) (consistency categories: A \\[watery\\] to D \\[hard\\]; higher categories indicate firmer stools)",{"measure":29,"description":30,"timeFrame":21},"Frequency of diarrhea","Frequency : Occurence of diarrhea",{"measure":32,"description":33,"timeFrame":21},"Severity of diarrhea","Severity of diarrhea assessed using a study-specific score calculated as the sum of the products of each watery stool and its volume over 2 days (minimum score: 6; no upper limit; higher scores indicate more severe diarrhea)",{"measure":35,"description":36,"timeFrame":21},"Frequency of constipation","Occurence of constipation",{"measure":38,"description":39,"timeFrame":21},"Severity of constipation","Severity of constipation assessed using a study-specific score (range: 1 to 3; higher scores indicate more severe constipation)",{"measure":41,"description":42,"timeFrame":21},"Crying time","Crying time reported by parents in class (Min : Less than 10 min \u002F Max : 3h or more)",{"measure":44,"description":45,"timeFrame":21},"Feeding refusal","Percentage of parents reporting feeding refusal by frequency of occurence (Never \u002F Rarely \u002F Sometimes \u002F Often \u002F Always)",{"measure":47,"description":48,"timeFrame":21},"Abnormal posturing","Percentage of parents reporting abnormal posturing by frequency of occurence (Never \u002F Rarely \u002F Sometimes \u002F Often \u002F Always)",{"measure":50,"description":51,"timeFrame":21},"Sleep quality","Percentage of parents reporting poor sleep quality (Excellent \u002F Good \u002F Fair \u002F Poor)",{"measure":53,"description":54,"timeFrame":21},"Anthropometric parameters - Weight","Body weight measured in kilograms (kg)",{"measure":56,"description":57,"timeFrame":21},"Anthropometric parameters - Length","Body length measured in centimeters (cm)",{"measure":59,"description":60,"timeFrame":21},"Anthropometric parameters - Head circumference","Head circumference measured in centimeters (cm)",{"measure":62,"description":63,"timeFrame":21},"Anthropometric parameters - BMI","Body mass index calculated as kg\u002Fm²",{"measure":65,"description":66,"timeFrame":21},"Anthropometric parameters - Weight-for-height z-score","Weight-for-height z-score calculated according to WHO Child Growth Standards",{"measure":68,"description":69,"timeFrame":21},"Use of drug treatments","Frequency of use of proton-pump inhibitors, prokinetics, other GERD treatment",{"measure":71,"description":72,"timeFrame":21},"Parents' satisfaction","Parental satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion)",{"measure":74,"description":75,"timeFrame":21},"Investigator's satisfaction","Investigator satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion)",null,{"allocation":78,"interventionModel":79,"interventionModelDescription":76,"primaryPurpose":80,"observationalModel":76,"timePerspective":76,"maskingInfo":81},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":82,"maskingDescription":76,"whoMasked":83},"QUADRUPLE",[84,85,86,87],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional).\n\nThe 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).",[90,96],{"label":91,"type":92,"description":93,"interventionNames":94},"Test","EXPERIMENTAL","new thickened infant formula containing fibres",[95],"Other: Experimental Infant formula",{"label":97,"type":98,"description":99,"interventionNames":100},"Control","ACTIVE_COMPARATOR","infant formula thickened with locust bean",[101],"Other: Infant formula thickened with locust bean gum",[103,108],{"type":104,"name":105,"description":106,"armGroupLabels":107,"otherNames":76},"OTHER","Experimental Infant formula","Exclusive formula feeding with the new infant formula thickened with fibers",[91],{"type":104,"name":109,"description":110,"armGroupLabels":111,"otherNames":76},"Infant formula thickened with locust bean gum","Exclusive formula feeding with the formula thickened with locust bean",[97],[113,118],{"name":114,"role":115,"phone":116,"phoneExt":76,"email":117},"Magalie JEGAT","CONTACT","+330155372222","m.jegat@novalac.com",{"name":119,"role":115,"phone":76,"phoneExt":76,"email":120},"ANNE-SOPHIE GARREAU","as.garreau@novalac.com",[122,134,146,156,166,176,186,196,206,218,229,241],{"facility":123,"status":124,"city":125,"state":76,"zip":76,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":133,"contacts":76},"Center_14","ACTIVE_NOT_RECRUITING","Namur","Belgium","BE",{"type":129,"coordinates":130},"Point",[131,132],4.86746,50.4669,{"lat":132,"lon":131},{"facility":135,"status":136,"city":137,"state":76,"zip":76,"country":126,"countryCode":127,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Center_15","RECRUITING","Thuin",{"type":129,"coordinates":139},[140,141],4.28604,50.33933,{"lat":141,"lon":140},[144],{"name":145,"role":115,"phone":76,"phoneExt":76,"email":76},"MD",{"facility":147,"status":124,"city":148,"state":76,"zip":76,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":76},"Center_09","Castelnau-le-Lez","France","FR",{"type":129,"coordinates":152},[153,154],3.90137,43.63605,{"lat":154,"lon":153},{"facility":157,"status":136,"city":158,"state":76,"zip":76,"country":149,"countryCode":150,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Center_02","Étampes",{"type":129,"coordinates":160},[161,162],2.16233,48.43507,{"lat":162,"lon":161},[165],{"name":145,"role":115,"phone":76,"phoneExt":76,"email":76},{"facility":167,"status":136,"city":168,"state":76,"zip":76,"country":149,"countryCode":150,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Center_05","Libourne",{"type":129,"coordinates":170},[171,172],-0.24186,44.91449,{"lat":172,"lon":171},[175],{"name":145,"role":115,"phone":76,"phoneExt":76,"email":76},{"facility":177,"status":136,"city":178,"state":76,"zip":76,"country":149,"countryCode":150,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Centre_10","Maromme",{"type":129,"coordinates":180},[181,182],1.02375,49.47925,{"lat":182,"lon":181},[185],{"name":145,"role":115,"phone":76,"phoneExt":76,"email":76},{"facility":187,"status":136,"city":188,"state":76,"zip":76,"country":149,"countryCode":150,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Center_16","Nice",{"type":129,"coordinates":190},[191,192],7.26608,43.70313,{"lat":192,"lon":191},[195],{"name":145,"role":115,"phone":76,"phoneExt":76,"email":76},{"facility":197,"status":136,"city":198,"state":76,"zip":76,"country":149,"countryCode":150,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Center_08","Vincennes",{"type":129,"coordinates":200},[201,202],2.43769,48.8486,{"lat":202,"lon":201},[205],{"name":145,"role":115,"phone":76,"phoneExt":76,"email":76},{"facility":207,"status":136,"city":208,"state":76,"zip":76,"country":209,"countryCode":210,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Center_01","Athens","Greece","GR",{"type":129,"coordinates":212},[213,214],23.72784,37.98376,{"lat":214,"lon":213},[217],{"name":145,"role":115,"phone":76,"phoneExt":76,"email":76},{"facility":219,"status":136,"city":220,"state":76,"zip":76,"country":209,"countryCode":210,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Center_11","Thessaloniki",{"type":129,"coordinates":222},[223,224],22.93493,40.64072,{"lat":224,"lon":223},[227],{"name":228,"role":115,"phone":76,"phoneExt":76,"email":76},"Ioanni, MD",{"facility":230,"status":136,"city":231,"state":76,"zip":76,"country":232,"countryCode":233,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Center_12","Naples","Italy","IT",{"type":129,"coordinates":235},[236,237],14.26811,40.85216,{"lat":237,"lon":236},[240],{"name":145,"role":115,"phone":76,"phoneExt":76,"email":76},{"facility":242,"status":136,"city":231,"state":76,"zip":76,"country":232,"countryCode":233,"cosmosGeoPoint":243,"geoPoint":245,"contacts":246},"Center_13",{"type":129,"coordinates":244},[236,237],{"lat":237,"lon":236},[247],{"name":145,"role":115,"phone":76,"phoneExt":76,"email":76},{"type":249,"investigatorFullName":76,"investigatorTitle":76,"investigatorAffiliation":76,"oldNameTitle":76,"oldOrganization":76},"SPONSOR",[251],{"name":252,"class":6},"Statitec","100389996",false,"NCT04358146","Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)","Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial","STELLAR","Inclusion Criteria:\n\n* ≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days,\n* exclusive or predominant formula feeding\n* whose parents signed informed consent\n\nExclusion Criteria:\n\n* preterm infants or birthweight \\\u003C2500g\n* Post enteritis lactose intolerance\n* Suspected or diagnosed cow's milk protein allergy requiring an eviction diet\n* Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1)\n* Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject","ALL","2 Weeks","4 Months",{"count":264,"type":265},346,"ESTIMATED","INTERVENTIONAL",[268],"NA","The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.",[271],"Gastroesophageal Reflux in Children",[273],"Reflux","2026-04-30",{"date":276,"type":277},"2026-05-04","ACTUAL",{"date":279,"type":277},"2023-03-17",{"date":281,"type":265},"2026-12-03",{"name":5,"class":6},12]