Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-25 @ 2:47 PM
Study NCT ID:
NCT00929292
Status:
COMPLETED
Last Update Posted:
2009-06-29
First Post:
2009-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003085', 'term': 'Colic'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, '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': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-26', 'studyFirstSubmitDate': '2009-06-26', 'studyFirstSubmitQcDate': '2009-06-26', 'lastUpdatePostDateStruct': {'date': '2009-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Crying duration per 24 hours', 'timeFrame': '1 day before the first consumption ; 3 days before days 15 and 30'}], 'secondaryOutcomes': [{'measure': 'Growth Parameters', 'timeFrame': 'Day 30'}, {'measure': 'Clinical Tolerance', 'timeFrame': '3 days before days 15 and 30'}, {'measure': 'Number of therapeutic failures (no diminution in the intensity or the frequency of the digestive symptoms)', 'timeFrame': 'Durind the 15 first days of the diet and during the 15 last days of the diet'}, {'measure': 'Number of regurgitations per day', 'timeFrame': '3 days before days 15 and 30'}, {'measure': 'Gas and abdominal distensions', 'timeFrame': '3 days before days 15 and 30'}, {'measure': 'Necessary Additive treatments', 'timeFrame': '3 days before days 15 and 30'}, {'measure': "Parents' satisfaction", 'timeFrame': 'Days 15 and 30'}, {'measure': 'Agitation/Restlessness Period Duration', 'timeFrame': '3 days before days 15 and 30'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infant formula', 'Alpha-lactalbumin', 'Protein composition', 'Colic', 'Probiotics'], 'conditions': ['Growth', 'Colic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.', 'detailedDescription': 'This double-blind, placebo-controlled study was undertaken with 66 healthy infants with colic, aged 3 weeks to 3 months, fed a month either with the experimental formula (EF) or with the control formula (CF) and evaluated for efficacy and safety parameters at days 15 and 30.\n\nBoth parents provided informed written consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '3 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy term infants with a gestational age ranging from 37 to 42 weeks\n* Non breastfed children\n* Infants with normal growth\n* Infants presenting colic defined as crying periods at least 3 hours per days, 3 days per weeks, for more than 3 weeks\n* These crying periods could be associated with other digestive troubles(gas, abdominal distensions, regurgitations)\n* Apgar score \\> 5 to 7 minutes\n\nExclusion Criteria:\n\n* Infants with severe regurgitations\n* Newborn currently participating in another trial\n* Infants presenting a metabolic, nervous or organic disease able to interfere with the study\n* Infants presenting lactose intolerance\n* Evidence of protein cow's milk allergy\n* Mother who wants to keep breasfeeding"}, 'identificationModule': {'nctId': 'NCT00929292', 'briefTitle': 'Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sodilac'}, 'officialTitle': 'Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.', 'orgStudyIdInfo': {'id': 'DAH-CL3-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modilac Dahlia 1', 'description': 'Formula enriched with alpha-lactalbumin and containing a probiotic', 'interventionNames': ['Other: Modilac Dahlia 1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Modilac 1', 'description': 'Regular milk', 'interventionNames': ['Other: Modilac 1']}], 'interventions': [{'name': 'Modilac Dahlia 1', 'type': 'OTHER', 'otherNames': ['Dahlia'], 'description': 'Infant formula used for non breastfed children with colic', 'armGroupLabels': ['Modilac Dahlia 1']}, {'name': 'Modilac 1', 'type': 'OTHER', 'otherNames': ['Modilac'], 'description': 'Infant formula used for non breastfed children', 'armGroupLabels': ['Modilac 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92160', 'city': 'Antony', 'country': 'France', 'facility': 'Dr Francine Gressin-Cohen', 'geoPoint': {'lat': 48.75329, 'lon': 2.29668}}, {'zip': '92166', 'city': 'Antony', 'country': 'France', 'facility': "Hôpital privé d'Antony", 'geoPoint': {'lat': 48.75329, 'lon': 2.29668}}, {'zip': '93602', 'city': 'Aulnay-sous-Bois', 'country': 'France', 'facility': 'Hôpital Robert Ballanger', 'geoPoint': {'lat': 48.93814, 'lon': 2.49402}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Dr Brigitte Pacault', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Dr Michel Dogneton', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Dr Nassira Belaroussi Maamri', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '92130', 'city': 'Issy-les-Moulineaux', 'country': 'France', 'facility': 'Dr KALINDJIAN', 'geoPoint': {'lat': 48.82104, 'lon': 2.27718}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': "Groupe Hospitalier de l'Institut Catholique de Lille (GHICL)", 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '77100', 'city': 'Meaux', 'country': 'France', 'facility': 'Dr Christophe Grillon', 'geoPoint': {'lat': 48.96014, 'lon': 2.87885}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Dr COUPRIE Claire', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Dr RONZIER Monique', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '59223', 'city': 'Roncq', 'country': 'France', 'facility': 'Dr Locquet André', 'geoPoint': {'lat': 50.7533, 'lon': 3.12131}}], 'overallOfficials': [{'name': 'Christophe Dupont, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Saint Vincent de Paul'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sodilac', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Pr Christophe Dupont', 'oldOrganization': 'Hôpital Saint Vincent de Paul'}}}}