Tolerance and Digestibility of a New Formula in Healthy Infants

Lactalis

Status and phase

Completed

Phase 2

Conditions

Steatorrhea

Growth

Treatments

Dietary Supplement: dairy lipids and soluble milk proteins

Study type

Interventional

Funder types

Industry

Identifiers

NCT01184378

LRD-08-15

Details and patient eligibility

About

The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk.

Enrollment

100 estimated patients

Sex

All

Ages

2 to 4 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

normal growth;
considered as healthy by the investigator according to the medical interrogation and the clinical examination;
receiving exclusively infant formula for at least 15 days.
without any solid food during the month of the study

Exclusion criteria

Premature born children or small born weights;
Children breast-fed or weaned for less than 15 days;
Children with solid food
Food allergy, particularly in milk proteins allergy , and lactose intolerance ;
Tumoral, inflammatory, cardiac, lung, renal, digestive diseases(syndrome of malabsorption);
Digestive pathology previous to the inclusion, in particular infectious (rotavirus, gastroenteritis) or functional symptoms (important stomach pains, colicky) having required a lot of change in formula quality;
Children under medical treatment (ex: paracetamol).