NCT03488758

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2021

Completed
Last Updated

December 27, 2021

Status Verified

December 1, 2021

Enrollment Period

3.5 years

First QC Date

March 28, 2018

Last Update Submit

December 23, 2021

Conditions

Feeding BehaviorFeeding, Bottle

Outcome Measures

Primary Outcomes (1)

  • Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).

    Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).

    1 month

Secondary Outcomes (10)

  • Feeding behaviour assessed by Montreal Children's Hospital Feeding Scale

    1 month

  • Quality of life assessed by QUALIN

    1 month

  • Formula liking, using 4-point visual analog scale (VAS)

    1 month

  • Incidences of rash

    1 month

  • Incidences of dry skin

    1 month

  • +5 more secondary outcomes

Study Arms (2)

CMF

ACTIVE COMPARATOR

infant formula based on cow milk protein fractions

Other: CMF

GMF

EXPERIMENTAL

infant formula based on whole goat milk

Other: GMF

Interventions

CMFOTHER

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

CMF
GMFOTHER

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

GMF

Eligibility Criteria

Age2 Months - 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Infants born less than 37GA
  • Confirmed or suspected cow milk protein allergy
  • Predominantly breast fed
  • Infants suffering from chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

2 Avenue Camille Blanc,

Beausoleil, 06240, France

Location

20 avenue du général Sarail

Chatou, 78400, France

Location

65 Avenue Henri Barbusse,

Le Blanc-Mesnil, 93150, France

Location

53 Boulevard De La Liberté

Les Lilas, 93260, France

Location

41 Rue Aristide Briand,

Levallois-Perret, 92300, France

Location

157 Avenue du Général Leclerc

Maisons-Alfort, 94700, France

Location

169 Avenue Achille Peretti

Neuilly-sur-Seine, 92200, France

Location

4 Rue Edouard Quenu

Paris, 75005, France

Location

67 Rue Condorcet,

Paris, 75009, France

Location

67 Rue Condorcet

Paris, 75009, France

Location

92 Avenue de la République

Paris, 75011, France

Location

CHU Robert Debré, 48 Bd Sérurier

Paris, 75019, France

Location

3 Allée du 8 Mai 1945,

Suresnes, 92150, France

Location

13 Villa Beauséjour

Vincennes, 94300, France

Location

Related Publications (18)

  • 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: 3372804BACKGROUND

  • Bates JE, Freeland CA, Lounsbury ML. Measurement of infant difficultness. Child Dev. 1979 Sep;50(3):794-803.

    PMID: 498854BACKGROUND

  • 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: 19545360BACKGROUND

  • 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: 3998939BACKGROUND

  • 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: 15893282BACKGROUND

  • 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: 21595890BACKGROUND

  • 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: 1688683BACKGROUND

  • 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: 21672566BACKGROUND

  • 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: 11430276BACKGROUND

  • 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: 10911526BACKGROUND

  • 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: 11207184BACKGROUND

  • 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: 25373935BACKGROUND

  • 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: 10618762BACKGROUND

  • 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: 22379377BACKGROUND

  • 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: 9403766BACKGROUND

  • 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: 14599049BACKGROUND

  • 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: 24502951BACKGROUND

  • 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.

    PMID: 37764840DERIVED

MeSH Terms

Conditions

Feeding BehaviorBottle Feeding

Interventions

Glia Maturation Factor

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Nerve Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsNerve Tissue ProteinsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 5, 2018

Study Start

June 1, 2018

Primary Completion

December 5, 2021

Study Completion

December 5, 2021

Last Updated

December 27, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(14)