Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein (CHARLIE)

December 23, 2021 updated by: Centre Hospitalier Intercommunal Creteil
To assess parental perceptions on infant feeding behavior and enjoyment with a goat milk formula compared to a cow milk formula

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 months to 3 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: CMF
infant formula based on cow milk protein fractions
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
EXPERIMENTAL: GMF
infant formula based on whole goat milk
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).
Time Frame: 1 month
Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feeding behaviour assessed by Montreal Children's Hospital Feeding Scale
Time Frame: 1 month
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
Quality of life assessed by QUALIN
Time Frame: 1 month
Quality of life assessed by QUALIN
1 month
Formula liking, using 4-point visual analog scale (VAS)
Time Frame: 1 month
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
Incidences of rash
Time Frame: 1 month
Incidences of rash
1 month
Incidences of dry skin
Time Frame: 1 month
Incidences of dry skin
1 month
Incidences of eczema
Time Frame: 1 month
Incidences of eczema
1 month
Gastrointestinal symptoms
Time Frame: 1 month
Gastrointestinal symptoms
1 month
Weight
Time Frame: 1 month
1 month
Height
Time Frame: 1 month
1 month
head circomference
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Intercommunal Creteil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHARLIE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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