Clinical trial NCT03936257: Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months
Official title: Evaluation of an Innovative BIO Formula Based on a New Whey Extraction Process on the Growth and Tolerance of Infants From 0 to 6 Months.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
Collaborators: name: Sodiaal International
First posted: 2019-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations.

The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated.

This study, defined as a pilot study, proposes to evaluate the innovative "TrueGreen" BIO infant formula based on a new whey extraction method on the growth and tolerance of infants from 0 to 6 months compared to the conventional BIO infant formula. As no growth and tolerance data are currently available for this new TrueGreen BIO formula, this study aims to determine them.


Eligibility criteria: Inclusion Criteria:

* 0 to 3 weeks
* Child followed by a general practitioner or pediatrician
* Informed consent form signed by the legal representatives of the subject
* Commitment of legal representatives to follow the constraints generated by the study
* Insured

Exclusion Criteria:

* Infant born prematurely before 37 weeks of amenorrhea
* Child allergic to cow's milk proteins
* Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);
* Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma, diabetes, digestive, renal, cardiac or haematological diseases);
* Incapacity for the legal representative(s) to understand or adhere to the protocol
* Subject involved in another clinical study or in an exclusion period from another study
* Legal representatives deprived of liberty
* Legal representatives in a position to judicial protection
* Weight of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
* Subject height according to age and sex, not between the 3rd and the 97th percentile of the WHO Child Growth Standards
* BMI of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
* Head circumference of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO (World Health Organization) Child Growth Standards
* The investigator considers that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study.

Primary outcomes:
measure: Evolution of growth of infants
timeFrame: from 0 to 6 months
Secondary outcomes:
measure: Height evolution of infants
timeFrame: from 0 to 6 months
measure: BMI evolution of infants
timeFrame: from 0 to 6 months
measure: Head circumference evolution of infants
timeFrame: from 0 to 6 months
measure: Number of colic per day
timeFrame: from 0 to 6 months
measure: Consistency of stool
timeFrame: from 0 to 6 months
measure: Number of regurgitation
timeFrame: from 0 to 6 months
measure: Number of wake up per night
timeFrame: from 0 to 6 months
measure: Total sleep time per day
timeFrame: from 0 to 6 months
measure: Plasma amino acid profile
timeFrame: between 3rd and 4th month
measure: Metabolomic analysis from plasma and urine samples
timeFrame: between 3rd and 4th month
Other outcomes:
Locations:
city: Lille
country: France
facility: NutrInvest - Institut Pasteur de Lille
state: Nord
Study officials:
affiliation: Institut Pasteur de Lille - NutrInvest
name: Jean-Michel Lecerf, MD
role: PRINCIPAL_INVESTIGATOR
References: