Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein
NCT ID: NCT03488758
Last Updated: 2021-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2018-06-01
2021-12-05
Brief Summary
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Detailed Description
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The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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CMF
infant formula based on cow milk protein fractions
CMF
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
GMF
infant formula based on whole goat milk
GMF
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
Interventions
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CMF
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
GMF
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Confirmed or suspected cow milk protein allergy
* Predominantly breast fed
* Infants suffering from chronic disease
2 Months
3 Months
ALL
Yes
Sponsors
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Centre Hospitalier Intercommunal Creteil
OTHER
Responsible Party
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Locations
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2 Avenue Camille Blanc,
Beausoleil, , France
20 avenue du général Sarail
Chatou, , France
65 Avenue Henri Barbusse,
Le Blanc-Mesnil, , France
53 Boulevard De La Liberté
Les Lilas, , France
41 Rue Aristide Briand,
Levallois-Perret, , France
157 Avenue du Général Leclerc
Maisons-Alfort, , France
169 Avenue Achille Peretti
Neuilly-sur-Seine, , France
4 Rue Edouard Quenu
Paris, , France
67 Rue Condorcet,
Paris, , France
67 Rue Condorcet
Paris, , France
92 Avenue de la République
Paris, , France
CHU Robert Debré, 48 Bd Sérurier
Paris, , France
3 Allée du 8 Mai 1945,
Suresnes, , France
13 Villa Beauséjour
Vincennes, , France
Countries
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References
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Bates JE, Freeland CA, Lounsbury ML. Measurement of infant difficultness. Child Dev. 1979 Sep;50(3):794-803.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CHARLIE
Identifier Type: -
Identifier Source: org_study_id