Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT00920166
Status:
COMPLETED
Last Update Posted:
2009-06-15
First Post:
2009-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-12', 'studyFirstSubmitDate': '2009-06-12', 'studyFirstSubmitQcDate': '2009-06-12', 'lastUpdatePostDateStruct': {'date': '2009-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth Parameters', 'timeFrame': '1, 3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'Sensitization or allergy', 'timeFrame': '1, 3 and 6 months'}, {'measure': 'Atopic diseases (eczema atopic, asthma, allergic rhinitis)', 'timeFrame': '1, 3 and 6 months'}, {'measure': 'Describe the intestinal flora according to the nutrition group', 'timeFrame': '1 and 6 months'}, {'measure': 'Clinical Tolerance', 'timeFrame': '1 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infant formula', 'Alpha-lactalbumin', 'Symbiotic', 'Allergy', 'Gastrointestinal tolerance', 'Bacterial colonization', 'Faecal IgA analysis'], 'conditions': ['Growth']}, 'referencesModule': {'references': [{'pmid': '22079177', 'type': 'DERIVED', 'citation': 'Roze JC, Barbarot S, Butel MJ, Kapel N, Waligora-Dupriet AJ, De Montgolfier I, Leblanc M, Godon N, Soulaines P, Darmaun D, Rivero M, Dupont C. An alpha-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial. Br J Nutr. 2012 Jun;107(11):1616-22. doi: 10.1017/S000711451100479X. Epub 2011 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.', 'detailedDescription': "This prospective, randomized, double blind, controlled study evaluated the safety and effect on growth and tolerance to an infant formula supplemented with alpha-lactalbumin and containing a symbiotic, in term infants.\n\nTerm infants with a gestational age ranging from 37 to 42 weeks and whose parents chose formula feeding were enrolled during their first eight days of life.\n\nBoth parents provided informed written consent. Infants were randomly assigned to receive either the new test formula or a control, a regular formula adapted for term infants (Modilac®1). The control formula is formulated to meet the nutritional needs of infants.\n\nFor each neonates, neonatal parameters were collected.\n\n5 visits took place : V1 (inclusion), V2 (randomization), V3 (1 month), V4 (3 months) and V5 (6 months). During each visit, the investigator filled in observational book the anthropometric parameters (weight, height, head circumference, BMI) and pieces of information collected 3 days before by the parents (gastrointestinal tolerance parameters, daily infant behaviour and milk consumption). Global parents' contentment was evaluated as well.\n\nIn two investigation centers, at the end of the 6th month, immuno-allergic test was realised.\n\nStools were collected at the end of the first and sixth month from diapers, for microbiological analysis and measurements of faecal inflammatory markers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term health newborn infant with gestational age ranging from 37 to 42 weeks\n* Eutrophic\n* Non breastfed children\n* Apgar score \\> 5 to 7 minutes\n\nExclusion Criteria:\n\n* Infant presenting a metabolic, nervous, digestive or organic disease able to interfere with study\n* Evidence of protein cow milk allergy\n* Infant presenting lactose intolerance\n* Newborn whose parents did not provide informed consent\n* Newborn currently participating in another trial'}, 'identificationModule': {'nctId': 'NCT00920166', 'acronym': 'Pétunia', 'briefTitle': 'Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sodilac'}, 'officialTitle': 'Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic', 'orgStudyIdInfo': {'id': 'PET-CL3-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modilac Pétunia 1', 'description': 'Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic', 'interventionNames': ['Dietary Supplement: Pétunia 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modilac 1', 'description': 'Regular milk', 'interventionNames': ['Dietary Supplement: Regular formula']}], 'interventions': [{'name': 'Pétunia 1', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Modilac Pétunia 1'], 'description': 'Infant formula used for non breastfed children', 'armGroupLabels': ['Modilac Pétunia 1']}, {'name': 'Regular formula', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Modilac 1'], 'description': 'Infant formula used for non breastfed children', 'armGroupLabels': ['Modilac 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Vincent de Paul (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital de la Pitié Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean Christophe Rozé, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sodilac', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Pr Jean Christophe Rozé (Principal investigator)', 'oldOrganization': 'CHU de Nantes'}}}}