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Clinical Trial 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.

Even clinical studies are not required to market an infant formula, it is important to obtain objective date on infant growth. Therefore, this study proposes to evaluate the effect of the consumption of an infant formula on the growth of infants from 0 to 6 months in comparison with the growth curves of the World Health Organization (WHO).

Clinical Trial Description


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

NCT number NCT02997826
Study type Interventional
Source Institut Pasteur de Lille
Contact Coralie Schnebelen, PhD
Phone 3 20 87 72 30
Email [email protected]
Status Recruiting
Phase N/A
Start date November 2016

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