ClinicalTrials.gg
CompletedNCT03488758CHARLIEUpdated Dec 27, 2021

Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

An interventional study of CMF and GMF in Feeding Behavior and Feeding, Bottle, sponsored by Centre Hospitalier Intercommunal Creteil. Completed at 14 sites in France. Open to participants aged 2 Months to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-27.

Sponsored by Centre Hospitalier Intercommunal Creteil · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
2 Months to 3 Months
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Feeding Behavior
  • Feeding, Bottle
03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's enrollment of 73 is close to the median of 77 across 700 interventional studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 3 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Infants born less than 37GA
  • Confirmed or suspected cow milk protein allergy
  • Predominantly breast fed
  • Infants suffering from chronic disease
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
73 participants (actual)

Study arms

  • Active comparator
    CMF

    infant formula based on cow milk protein fractions

    Other: CMF

  • Experimental
    GMF

    infant formula based on whole goat milk

    Other: GMF

Interventions

  • OtherCMF

    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

  • OtherGMF

    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

06

What researchers measure

Primary outcomes

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

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

    Time frame: 1 month

Secondary outcomes

  1. 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)

    Time frame: 1 month

  2. Quality of life assessed by QUALIN

    Quality of life assessed by QUALIN

    Time frame: 1 month

  3. 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)

    Time frame: 1 month

  4. Incidences of rash

    Incidences of rash

    Time frame: 1 month

  5. Incidences of dry skin

    Incidences of dry skin

    Time frame: 1 month

  6. Incidences of eczema

    Incidences of eczema

    Time frame: 1 month

  7. Gastrointestinal symptoms

    Gastrointestinal symptoms

    Time frame: 1 month

  8. Weight

    Time frame: 1 month

  9. Height

    Time frame: 1 month

  10. head circomference

    Time frame: 1 month

07

Study locations

14 sites
  • 2 Avenue Camille Blanc,
    Beausoleil, 06240, France
  • 20 avenue du général Sarail
    Chatou, 78400, France
  • 65 Avenue Henri Barbusse,
    Le Blanc-Mesnil, 93150, France
  • 53 Boulevard De La Liberté
    Les Lilas, 93260, France
  • 41 Rue Aristide Briand,
    Levallois-Perret, 92300, France
  • 157 Avenue du Général Leclerc
    Maisons-Alfort, 94700, France
  • 169 Avenue Achille Peretti
    Neuilly-sur-Seine, 92200, France
  • 4 Rue Edouard Quenu
    Paris, 75005, France
  • 67 Rue Condorcet,
    Paris, 75009, France
  • 67 Rue Condorcet
    Paris, 75009, France
  • 92 Avenue de la République
    Paris, 75011, France
  • CHU Robert Debré, 48 Bd Sérurier
    Paris, 75019, France
  • 3 Allée du 8 Mai 1945,
    Suresnes, 92150, France
  • 13 Villa Beauséjour
    Vincennes, 94300, France
08

References and documents

Publications

  • 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. PubMed 3372804 ↗
  • Bates JE, Freeland CA, Lounsbury ML. Measurement of infant difficultness. Child Dev. 1979 Sep;50(3):794-803. PubMed 498854 ↗
  • 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. PubMed 19545360 ↗
  • 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. PubMed 3998939 ↗
  • 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. PubMed 15893282 ↗
  • 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. PubMed 21595890 ↗
  • 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. PubMed 1688683 ↗
  • 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. PubMed 21672566 ↗
  • 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. PubMed 11430276 ↗
  • 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. PubMed 10911526 ↗
  • 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. PubMed 11207184 ↗
  • 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. PubMed 25373935 ↗
  • 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. PubMed 10618762 ↗
  • 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. PubMed 22379377 ↗
  • 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. PubMed 9403766 ↗
  • 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. PubMed 14599049 ↗
  • 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. PubMed 24502951 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03488758
Responsible party
Sponsor
First posted
Apr 5, 2018
Start date
Jun 1, 2018
Primary completion
Dec 5, 2021
Completion
Dec 5, 2021
Last update
Dec 27, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion