Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

Feeding Behavior Clinical Trial

— CHARLIE  

Official title:

Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488758
• Other study ID #: CHARLIE
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 5, 2021

Study information

• Verified date: December 2021
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess parental perceptions on infant feeding behavior and enjoyment with a goat milk formula compared to a cow milk formula

Description:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 5, 2021
• Est. primary completion date: December 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 3 Months

Eligibility

Inclusion Criteria:

• Healthy infants aged 2-3 months, predominantly formula fed

Exclusion Criteria:

• Infants born less than 37GA

• Confirmed or suspected cow milk protein allergy

• Predominantly breast fed

• Infants suffering from chronic disease

Related Conditions & MeSH terms

• Feeding Behavior
• Feeding, Bottle

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

References & Publications (17)

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. — View Citation

Bates JE, Freeland CA, Lounsbury ML. Measurement of infant difficultness. Child Dev. 1979 Sep;50(3):794-803. — View 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. — View 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. — View 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. Epub 2005 Mar 2. — View 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. — View Citation

Kunz C, Lönnerdal 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. — View 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. — View Citation

Long T, Johnson M. Living and coping with excessive infantile crying. J Adv Nurs. 2001 Apr;34(2):155-62. — View 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. French. — View 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. — View 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. — View Citation

Polack FP, Khan N, Maisels MJ. Changing partners: the dance of infant formula changes. Clin Pediatr (Phila). 1999 Dec;38(12):703-8. — View 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. — View Citation

Recio I, Pérez-Rodríguez 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. — View 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. — View Citation

Zhou SJ, Sullivan T, Gibson RA, Lönnerdal 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).	Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).	1 month
Secondary	Feeding behaviour assessed by Montreal Children's Hospital Feeding Scale	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)	1 month
Secondary	Quality of life assessed by QUALIN	Quality of life assessed by QUALIN	1 month
Secondary	Formula liking, using 4-point visual analog scale (VAS)	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)	1 month
Secondary	Incidences of rash	Incidences of rash	1 month
Secondary	Incidences of dry skin	Incidences of dry skin	1 month
Secondary	Incidences of eczema	Incidences of eczema	1 month
Secondary	Gastrointestinal symptoms	Gastrointestinal symptoms	1 month
Secondary	Weight		1 month
Secondary	Height		1 month
Secondary	head circomference		1 month