AzTrials
AzTrials

Feeding BehaviorCHARLIENCT03488758

Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

A study testing CMF and GMF in people with Feeding Behavior and Feeding, Bottle, run by Centre Hospitalier Intercommunal Creteil at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To assess parental perceptions on infant feeding behavior and enjoyment with a goat milk formula compared to a cow milk formula Read more about this study

Who is it for?
Ages 2 to 3 monthsHealthy volunteers can take part
Conditions the study is for
Feeding Behavior, Feeding, Bottle
What is being tested?
CMF and GMF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
14 sitesFrance
Study dates
1 Jun 2018to 5 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 3 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • 2 Avenue Camille Blanc,

    Beausoleil, 06240

  • 20 avenue du général Sarail

    Chatou, 78400

  • 65 Avenue Henri Barbusse,

    Le Blanc-Mesnil, 93150

  • 53 Boulevard De La Liberté

    Les Lilas, 93260

  • 41 Rue Aristide Briand,

    Levallois-Perret, 92300

  • 157 Avenue du Général Leclerc

    Maisons-Alfort, 94700

  • 169 Avenue Achille Peretti

    Neuilly-sur-Seine, 92200

  • 4 Rue Edouard Quenu

    Paris, 75005

  • 67 Rue Condorcet,

    Paris, 75009

  • 67 Rue Condorcet

    Paris, 75009

  • 92 Avenue de la République

    Paris, 75011

  • CHU Robert Debré, 48 Bd Sérurier

    Paris, 75019

  • 3 Allée du 8 Mai 1945,

    Suresnes, 92150

  • 13 Villa Beauséjour

    Vincennes, 94300

Other trials in France

About this study

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.

Being tested
CMF, GMF
Medical subject headings
Feeding Behavior, Bottle Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

Study groups in NCT03488758
Study groupRoleWhat they receive
CMFActive comparatorinfant formula based on cow milk protein fractions
Receives: Other: CMF
GMFExperimentalinfant formula based on whole goat milk
Receives: Other: GMF

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 1 month

Secondary outcomes (10)

  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)

    Measured: 1 month

  2. Quality of life assessed by QUALIN

    Quality of life assessed by QUALIN

    Measured: 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)

    Measured: 1 month

  4. Incidences of rash

    Incidences of rash

    Measured: 1 month

  5. Incidences of dry skin

    Incidences of dry skin

    Measured: 1 month

  6. Incidences of eczema

    Incidences of eczema

    Measured: 1 month

  7. Gastrointestinal symptoms

    Gastrointestinal symptoms

    Measured: 1 month

  8. Weight

    Measured: 1 month

  9. Height

    Measured: 1 month

  10. head circomference

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2018
  2. Study start1 Jun 2018
  3. Primary completion5 Dec 2021
  4. Study completion5 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03488758
Sponsor's protocol ID
CHARLIE
Acronym
CHARLIE
Status last verified
Dec 2021
First submitted
28 Mar 2018
Last updated
27 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing CMF and GMF in people with Feeding Behavior and Feeding, Bottle, run by Centre Hospitalier Intercommunal Creteil at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ). (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03488758, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in