Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-01-09 @ 1:26 AM
Study NCT ID:
NCT01909661
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2013-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005183', 'term': 'Failure to Thrive'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-16', 'studyFirstSubmitDate': '2013-07-18', 'studyFirstSubmitQcDate': '2013-07-23', 'lastUpdatePostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Volume of infant formula consumed by the infants', 'timeFrame': '3 months', 'description': 'Volume of infant formula consumed by the infants in 3 months'}], 'primaryOutcomes': [{'measure': 'Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption.', 'timeFrame': '24h', 'description': 'Tolerance is absence of clinical signs.'}], 'secondaryOutcomes': [{'measure': 'Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement.', 'timeFrame': '3 months', 'description': 'Evaluate during 3 months of consumption the effectiveness of the formulas, in terms of :\n\n* infant growth, through anthropometric measures (body weight, length and head circumference)\n* allergy symptoms, through the improvement of the allergy symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['allergy', "Cow's milk protein", 'Tolerance', 'Efficacy', "Infants' growth"], 'conditions': ['Cow Milk Protein Sensitivity', 'Tolerance', 'Growth Failure']}, 'descriptionModule': {'briefSummary': 'The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Full term healthy newborns (37-42 Weeks gestation)\n* Weight at birth ≥ 2500 g\n* Aged between birth to 9 months\n* Symptoms of allergy (Skin or digetive)\n* Suspicion of cow milk protein allergy\n* Infants whose parents/caregivers/legal guardians have the ability to understand and comply with the requirements of the study\n* Infants whose parents/caregivers/legal guardians gave their written informed consent to the infant's participation in the study\n\nExclusion Criteria:\n\n* Children who have returned to breastfeeding\n* Presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study\n* In the past 15 days, treatment or medication likely to :\n\n * induce confusion in the allergy tets (ex. : Skin Prick Test) and / or\n * mask the symptoms of an allergic reaction (Anti-allergy medications ; anti-histaminic, anti-leucotrienes, corticosteroids, …)\n* Newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results\n* Children who show signs of malnutrition, or prolonged diarrhea\n* Children whose parents show no willingness to comply with study requirements\n* Consumption of soya protein based, hydrolyzed protein or elemental (amino acid) formula for more than 21 days before inclusion, unless the skin prick test to cow's milk protein is positive, and the IgE level indicates the existence of IgE mediated allergy to cow's milk protein."}, 'identificationModule': {'nctId': 'NCT01909661', 'acronym': 'JUNGLO', 'briefTitle': "Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas", 'organization': {'class': 'INDUSTRY', 'fullName': 'Lactalis'}, 'officialTitle': 'Tolerancia a 2 fórmulas de Leche Infantil Altamente Hidrolizadas en Base a proteínas de Arroz y a caseína en niños Con Alergia a Las proteínas de Leche de Vaca', 'orgStudyIdInfo': {'id': 'LRD - 2013 - JUNGLO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Damira/Celia peptide hydrolyzed casein', 'description': 'Extensively Hydrolyzed (EH)casein infant formula', 'interventionNames': ['Other: Damira/Celia peptide hydrolyzed casein']}, {'type': 'EXPERIMENTAL', 'label': 'Picot riz/Celia rice/Sanutri arroz', 'description': 'Picot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula', 'interventionNames': ['Other: Picot riz/Celia rice/Sanutri arroz']}], 'interventions': [{'name': 'Damira/Celia peptide hydrolyzed casein', 'type': 'OTHER', 'armGroupLabels': ['Damira/Celia peptide hydrolyzed casein']}, {'name': 'Picot riz/Celia rice/Sanutri arroz', 'type': 'OTHER', 'armGroupLabels': ['Picot riz/Celia rice/Sanutri arroz']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18004', 'city': 'Granada', 'country': 'Spain', 'facility': 'Biosearch S.A.', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lactalis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biosearch S.A.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}