Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-02-22 @ 7:04 PM
Study NCT ID:
NCT01894893
Status:
COMPLETED
Last Update Posted:
2016-01-05
First Post:
2013-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atlas of Human Milk Nutrients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. Mother milk\n2. Umbilical cord blood\n3. Mother blood\n4. Adipose tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2013-04-25', 'studyFirstSubmitQcDate': '2013-07-04', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of human milk components', 'timeFrame': 'Between 0 and 4 months after delivery', 'description': "Nutrients in human breast milk samples will be characterized and quantified by analysing with modern analytical techniques (NMR, HPLC-MS and GC-MS) the human milk samples collected at each study visits (3d, 14 days, 1m, 2m, 3m and 4 months after delivery, 1 week after delivery, ). The parameters which will be assessed in human milk samples are : Total Energy Value, Total Macronutrients (lipids, proteins, carbohydrates, solids), Lipids' characterization, Peptide profiling, Oligosaccharides profiling, and Micro-RNA profiling. It will be done in 240 completed mothers."}], 'secondaryOutcomes': [{'measure': "Human milk composition versus mothers' diet data", 'timeFrame': 'between 3 months before delivery and 4 months after delivery', 'description': "The human milk composition profiles (primary outcome) will be correlated in a longitudinal manner to mothers' diet. Information on mother's diet will be collected using a 3-days diary and entering the data in Nutrilog (total intake of the mothers). This will be done before each study visit in 240 completed mothers."}, {'measure': 'Human milk composition versus maternal clinical parameters', 'timeFrame': 'Between 0 and 4 months after delivery', 'description': "The human milk composition profiles will be correlated in a longitudinal manner to the stage of lactation, the gestation's age, the type of delivery, the sex of the baby, the number of babies the mother already had (gravidity and parity), single/multiple birth. It will be done in 240 completed mothers."}, {'measure': 'Human milk composition versus mother and infant clinical parameters', 'timeFrame': 'Between 0 and 4 months after delivery', 'description': 'The human milk composition profiles will be correlated in a longitudinal manner to infant anthropometric measurements (weight, height and head circumference). It will be done in 240 completed mothers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breastfeeding Mothers']}, 'referencesModule': {'references': [{'pmid': '34510208', 'type': 'DERIVED', 'citation': 'Raymond F, Lefebvre G, Texari L, Pruvost S, Metairon S, Cottenet G, Zollinger A, Mateescu B, Billeaud C, Picaud JC, Silva-Zolezzi I, Descombes P, Bosco N. Longitudinal Human Milk miRNA Composition over the First 3 mo of Lactation in a Cohort of Healthy Mothers Delivering Term Infants. J Nutr. 2022 Jan 11;152(1):94-106. doi: 10.1093/jn/nxab282.'}, {'pmid': '33446921', 'type': 'DERIVED', 'citation': 'Binia A, Lavalle L, Chen C, Austin S, Agosti M, Al-Jashi I, Pereira AB, Costeira MJ, Silva MG, Marchini G, Martinez-Costa C, Stiris T, Stoicescu SM, Vanpee M, Rakza T, Billeaud C, Picaud JC, Domellof M, Adams R, Castaneda-Gutierrez E, Sprenger N. Human milk oligosaccharides, infant growth, and adiposity over the first 4 months of lactation. Pediatr Res. 2021 Sep;90(3):684-693. doi: 10.1038/s41390-020-01328-y. Epub 2021 Jan 14.'}]}, 'descriptionModule': {'briefSummary': "The main objective of this clinical trial is to collect human milk samples from 0 to 4 months after delivery in order to characterize human milk components. The secondary objectives of this study are:\n\n1. To assess whether there is a correlation between human milk composition and mothers' diet\n2. To assess whether there is a correlation between human milk composition and maternal clinical parameters\n3. To assess whether there is a correlation between human milk composition and mother and infant clinical parameters"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy mothers of any ethnicity having decided to exclusively breast-feed their new born baby from birth up to 4 months of age will be eligible to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 40 years of age included at time of enrolment\n* BMI before pregnancy between 19 and 29 included\n* Having signed the Informed Consent Form\n* Having decided to exclusively breast-feed until infant is 4 months old\n\nExclusion Criteria:\n\n* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study\n* Presenting any disease or medical condition which might prevent breast-feeding or collection the human milk samples or for which breast-feeding is not indicated\n* Presenting diseases/medical conditions such as diabetes, heart problems, abnormal conditions of pregnancy (ex. hypertension)\n* Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease\n* Assuming any medication indicated for the treatment of any metabolic or cardiovascular disease\n* Cannot be expected to comply with the study procedures'}, 'identificationModule': {'nctId': 'NCT01894893', 'briefTitle': 'Atlas of Human Milk Nutrients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Atlas of Human Milk Nutrients', 'orgStudyIdInfo': {'id': '11.33.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breastfeeding mothers'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Varese', 'country': 'Italy', 'facility': 'Ospedale del Ponte', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Braga', 'country': 'Portugal', 'facility': 'Centro Hospitalar do Alto Ave Guimarães Hospital', 'geoPoint': {'lat': 41.5514, 'lon': -8.42311}}, {'city': 'Braga', 'country': 'Portugal', 'facility': 'Hospital de São Marcos', 'geoPoint': {'lat': 41.5514, 'lon': -8.42311}}, {'city': 'Porto', 'country': 'Portugal', 'facility': 'Hospital de S. João', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Al Jashi Isam Private Med. Practice', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Polizu Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '171 76', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Department of Woman and Child Health, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umeå University hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Claude Billeaud, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'Jean-Charles Picaud, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital de la Croix-Rousse'}, {'name': 'Thameur Rakza, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de Lille'}, {'name': 'Massimo Agosti, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale del Ponte Varese'}, {'name': 'Tom Stiris, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}, {'name': 'Silva Gorett, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de S. João Porto'}, {'name': 'Almerinda Barroso Pereira, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de São Marcos - Braga'}, {'name': 'Maria Jose Costeira, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guimarães Hospital Braga'}, {'name': 'Isam Al-Jashi, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al Jashi Isam Private Med. Practice Bucharest'}, {'name': 'Sylvia Stoicescu, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Polizu Hospital Bucharest'}, {'name': 'Cecilia Martinez-Costa, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínico Universitario de Valencia'}, {'name': 'Magnus Domellöf,, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}, {'name': 'Mireille Vanpeé, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University hospital in Solna'}, {'name': 'Giovanna Marchini, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University hospital in Solna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}