Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-27 @ 11:10 AM
Study NCT ID:
NCT01940068
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2013-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016269', 'term': 'Milk Hypersensitivity'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-20', 'studyFirstSubmitDate': '2013-09-06', 'studyFirstSubmitQcDate': '2013-09-06', 'lastUpdatePostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of withdrawal for intolerance', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypersensitivity', 'Milk Hypersensitivity', 'Immune System Diseases', 'Food Hypersensitivity'], 'conditions': ['Cow Milk Allergy']}, 'referencesModule': {'references': [{'pmid': '33006765', 'type': 'DERIVED', 'citation': 'Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.'}, {'pmid': '25844709', 'type': 'DERIVED', 'citation': "Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, De Blay F, Guenard-Bilbault L, Hatahet R, Mulier S, Kapel N, Waligora-Dupriet AJ, Butel MJ. Safety of a New Amino Acid Formula in Infants Allergic to Cow's Milk and Intolerant to Hydrolysates. J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):456-63. doi: 10.1097/MPG.0000000000000803."}, {'pmid': '25446768', 'type': 'DERIVED', 'citation': "Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, de Blay F, Guenard-Bilbault L, Hatahet R, Mulier S. A thickened amino-acid formula in infants with cow's milk allergy failing to respond to protein hydrolysate formulas: a randomized double-blind trial. Paediatr Drugs. 2014 Dec;16(6):513-22. doi: 10.1007/s40272-014-0097-x."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '2 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* less than 18 months old\n* with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (\\>=6mm) or specific immunoglobulin E \\>= 5 kilo-unit/L or combination\n* still symptomatic while fed an extensively hydrolysed formula\n\nExclusion Criteria:\n\n* Exclusively breast fed infants\n* non allergic digestive enteropathy"}, 'identificationModule': {'nctId': 'NCT01940068', 'briefTitle': "A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates", 'organization': {'class': 'INDUSTRY', 'fullName': 'United Pharmaceuticals'}, 'officialTitle': "A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates", 'orgStudyIdInfo': {'id': 'PRO-UP05-E1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New Thickened Amino acid based formula', 'interventionNames': ['Dietary Supplement: Amino acid based formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amino acid based formula', 'interventionNames': ['Dietary Supplement: Amino acid based formula']}], 'interventions': [{'name': 'Amino acid based formula', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Amino acid based formula', 'New Thickened Amino acid based formula']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': "Necker Children's Hospital", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}