Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT03488758
Status:
COMPLETED
Last Update Posted:
2021-12-27
First Post:
2018-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001903', 'term': 'Bottle Feeding'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020904', 'term': 'Glia Maturation Factor'}], 'ancestors': [{'id': 'D009414', 'term': 'Nerve Growth Factors'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2018-03-28', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).', 'timeFrame': '1 month', 'description': 'Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).'}], 'secondaryOutcomes': [{'measure': "Feeding behaviour assessed by Montreal Children's Hospital Feeding Scale", 'timeFrame': '1 month', 'description': 'This feeding scale permit to distinguish babies with no feeding difficulties (score under 61) or with mild (61-65) , moderate (65-70), or severe feeding disorders (\\>70)'}, {'measure': 'Quality of life assessed by QUALIN', 'timeFrame': '1 month', 'description': 'Quality of life assessed by QUALIN'}, {'measure': 'Formula liking, using 4-point visual analog scale (VAS)', 'timeFrame': '1 month', 'description': 'Formula liking, using 4-point visual analog scale (VAS). The range of this scale goes from 0 (my baby hates this fomula) to 10 (my baby loves this formula)'}, {'measure': 'Incidences of rash', 'timeFrame': '1 month', 'description': 'Incidences of rash'}, {'measure': 'Incidences of dry skin', 'timeFrame': '1 month', 'description': 'Incidences of dry skin'}, {'measure': 'Incidences of eczema', 'timeFrame': '1 month', 'description': 'Incidences of eczema'}, {'measure': 'Gastrointestinal symptoms', 'timeFrame': '1 month', 'description': 'Gastrointestinal symptoms'}, {'measure': 'Weight', 'timeFrame': '1 month'}, {'measure': 'Height', 'timeFrame': '1 month'}, {'measure': 'head circomference', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Feeding Behavior', 'Feeding, Bottle']}, 'referencesModule': {'references': [{'pmid': '3372804', 'type': 'BACKGROUND', 'citation': 'Ambrosoli R, Di Stasio L, Mazzocco P. Content of alpha S1-casein and coagulation properties in goat milk. J Dairy Sci. 1988 Jan;71(1):24-8. doi: 10.3168/jds.S0022-0302(88)79520-X.'}, {'pmid': '498854', 'type': 'BACKGROUND', 'citation': 'Bates JE, Freeland CA, Lounsbury ML. Measurement of infant difficultness. Child Dev. 1979 Sep;50(3):794-803.'}, {'pmid': '19545360', 'type': 'BACKGROUND', 'citation': 'Berseth CL, Mitmesser SH, Ziegler EE, Marunycz JD, Vanderhoof J. Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27.'}, {'pmid': '3998939', 'type': 'BACKGROUND', 'citation': "Forsyth BW, McCarthy PL, Leventhal JM. Problems of early infancy, formula changes, and mothers' beliefs about their infants. J Pediatr. 1985 Jun;106(6):1012-7. doi: 10.1016/s0022-3476(85)80260-2."}, {'pmid': '15893282', 'type': 'BACKGROUND', 'citation': "Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2."}, {'pmid': '21595890', 'type': 'BACKGROUND', 'citation': "Infante DD, Segarra OO, Redecillas SS, Alvarez MM, Miserachs MM. Modification of stool's water content in constipated infants: management with an adapted infant formula. Nutr J. 2011 May 19;10:55. doi: 10.1186/1475-2891-10-55."}, {'pmid': '1688683', 'type': 'BACKGROUND', 'citation': 'Kunz C, Lonnerdal B. Human-milk proteins: analysis of casein and casein subunits by anion-exchange chromatography, gel electrophoresis, and specific staining methods. Am J Clin Nutr. 1990 Jan;51(1):37-46. doi: 10.1093/ajcn/51.1.37.'}, {'pmid': '21672566', 'type': 'BACKGROUND', 'citation': 'Llewellyn CH, van Jaarsveld CH, Johnson L, Carnell S, Wardle J. Development and factor structure of the Baby Eating Behaviour Questionnaire in the Gemini birth cohort. Appetite. 2011 Oct;57(2):388-96. doi: 10.1016/j.appet.2011.05.324. Epub 2011 Jun 6.'}, {'pmid': '11430276', 'type': 'BACKGROUND', 'citation': 'Long T, Johnson M. Living and coping with excessive infantile crying. J Adv Nurs. 2001 Apr;34(2):155-62. doi: 10.1046/j.1365-2648.2001.01740.x.'}, {'pmid': '10911526', 'type': 'BACKGROUND', 'citation': 'Manificat S, Dazord A, Langue J, Danjou G, Bauche P, Bovet F, Cubells J, Luchelli R, Tockert E, Conway K. [Evaluation of the quality of life of infants and very young children: validation of a questionnaire. Multicenter European study]. Arch Pediatr. 2000 Jun;7(6):605-14. doi: 10.1016/s0929-693x(00)80127-x. French.'}, {'pmid': '11207184', 'type': 'BACKGROUND', 'citation': 'Mitchell DJ, McClure BG, Tubman TR. Simultaneous monitoring of gastric and oesophageal pH reveals limitations of conventional oesophageal pH monitoring in milk fed infants. Arch Dis Child. 2001 Mar;84(3):273-6. doi: 10.1136/adc.84.3.273.'}, {'pmid': '25373935', 'type': 'BACKGROUND', 'citation': 'Nowacki J, Lee HC, Lien R, Cheng SW, Li ST, Yao M, Northington R, Jan I, Mutungi G. Stool fatty acid soaps, stool consistency and gastrointestinal tolerance in term infants fed infant formulas containing high sn-2 palmitate with or without oligofructose: a double-blind, randomized clinical trial. Nutr J. 2014 Nov 5;13:105. doi: 10.1186/1475-2891-13-105.'}, {'pmid': '10618762', 'type': 'BACKGROUND', 'citation': 'Polack FP, Khan N, Maisels MJ. Changing partners: the dance of infant formula changes. Clin Pediatr (Phila). 1999 Dec;38(12):703-8. doi: 10.1177/000992289903801202.'}, {'pmid': '22379377', 'type': 'BACKGROUND', 'citation': "Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17. doi: 10.1093/pch/16.3.147."}, {'pmid': '9403766', 'type': 'BACKGROUND', 'citation': 'Recio I, Perez-Rodriguez ML, Amigo L, Ramos M. Study of the polymorphism of caprine milk caseins by capillary electrophoresis. J Dairy Res. 1997 Nov;64(4):515-23. doi: 10.1017/s0022029997002343.'}, {'pmid': '14599049', 'type': 'BACKGROUND', 'citation': 'Savino F, Cresi F, Maccario S, Cavallo F, Dalmasso P, Fanaro S, Oggero R, Vigi V, Silvestro L. "Minor" feeding problems during the first months of life: effect of a partially hydrolysed milk formula containing fructo- and galacto-oligosaccharides. Acta Paediatr Suppl. 2003 Sep;91(441):86-90. doi: 10.1111/j.1651-2227.2003.tb00653.x.'}, {'pmid': '24502951', 'type': 'BACKGROUND', 'citation': 'Zhou SJ, Sullivan T, Gibson RA, Lonnerdal B, Prosser CG, Lowry DJ, Makrides M. Nutritional adequacy of goat milk infant formulas for term infants: a double-blind randomised controlled trial. Br J Nutr. 2014 May;111(9):1641-51. doi: 10.1017/S0007114513004212. Epub 2014 Feb 6.'}, {'pmid': '37764840', 'type': 'DERIVED', 'citation': 'Jung C, Gonzalez Serrano A, Batard C, Seror E, Gelwane G, Poidvin A, Lavallee I, Elbez A, Brussieux M, Prosser C, Gallier S, Bellaiche M. Whole Goat Milk-Based Formula versus Whey-Based Cow Milk Formula: What Formula Do Infants Enjoy More?-A Feasibility, Double-Blind, Randomized Controlled Trial. Nutrients. 2023 Sep 19;15(18):4057. doi: 10.3390/nu15184057.'}]}, 'descriptionModule': {'briefSummary': 'To assess parental perceptions on infant feeding behavior and enjoyment with a goat milk formula compared to a cow milk formula', 'detailedDescription': "This is a feasibility study to determine the utility of two new standardized psychometric tools for paediatricians to assess and manage feeding difficulties in formula fed infants. Baby Eating Behaviour Questionnaire (BEBQ) and Montreal Children's Hospital Feeding Scale (MCH-Feeding Scale) will be used in this study.\n\nThe secondary objectives are to determine if these tools can then measure the changes in behaviour after introducing two formula that differ in the sources of protein, ie formula made from whole goat milk compared to a conventional formula made from cow milk proteins. The quality of life and general health outcomes of these infants will also be monitored."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infants aged 2-3 months, predominantly formula fed\n\nExclusion Criteria:\n\n* Infants born less than 37GA\n* Confirmed or suspected cow milk protein allergy\n* Predominantly breast fed\n* Infants suffering from chronic disease'}, 'identificationModule': {'nctId': 'NCT03488758', 'acronym': 'CHARLIE', 'briefTitle': 'Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein', 'orgStudyIdInfo': {'id': 'CHARLIE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CMF', 'description': 'infant formula based on cow milk protein fractions', 'interventionNames': ['Other: CMF']}, {'type': 'EXPERIMENTAL', 'label': 'GMF', 'description': 'infant formula based on whole goat milk', 'interventionNames': ['Other: GMF']}], 'interventions': [{'name': 'CMF', 'type': 'OTHER', 'description': 'Taking a infant formula based on cow milk protein fractions, 4-5 feeds per day given by bottle, 180-210 ml/feed, total 800-900ml per day for one mounth', 'armGroupLabels': ['CMF']}, {'name': 'GMF', 'type': 'OTHER', 'description': 'Taking a infant formula based on whole goat milk, 4-5 feeds per day given by bottle, 180-210 ml/feed, total 800-900ml per day for one mounth', 'armGroupLabels': ['GMF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06240', 'city': 'Beausoleil', 'country': 'France', 'facility': '2 Avenue Camille Blanc,', 'geoPoint': {'lat': 43.74311, 'lon': 7.4225}}, {'zip': '78400', 'city': 'Chatou', 'country': 'France', 'facility': '20 avenue du général Sarail', 'geoPoint': {'lat': 48.8898, 'lon': 2.15863}}, {'zip': '93150', 'city': 'Le Blanc-Mesnil', 'country': 'France', 'facility': '65 Avenue Henri Barbusse,', 'geoPoint': {'lat': 48.93872, 'lon': 2.46138}}, {'zip': '93260', 'city': 'Les Lilas', 'country': 'France', 'facility': '53 Boulevard De La Liberté', 'geoPoint': {'lat': 48.87992, 'lon': 2.42057}}, {'zip': '92300', 'city': 'Levallois-Perret', 'country': 'France', 'facility': '41 Rue Aristide Briand,', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}, {'zip': '94700', 'city': 'Maisons-Alfort', 'country': 'France', 'facility': '157 Avenue du Général Leclerc', 'geoPoint': {'lat': 48.81171, 'lon': 2.43945}}, {'zip': '92200', 'city': 'Neuilly-sur-Seine', 'country': 'France', 'facility': '169 Avenue Achille Peretti', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': '4 Rue Edouard Quenu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75009', 'city': 'Paris', 'country': 'France', 'facility': '67 Rue Condorcet,', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75009', 'city': 'Paris', 'country': 'France', 'facility': '67 Rue Condorcet', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75011', 'city': 'Paris', 'country': 'France', 'facility': '92 Avenue de la République', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Robert Debré, 48 Bd Sérurier', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': '3 Allée du 8 Mai 1945,', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '94300', 'city': 'Vincennes', 'country': 'France', 'facility': '13 Villa Beauséjour', 'geoPoint': {'lat': 48.8486, 'lon': 2.43769}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}