Status:
COMPLETED
Tolerance and Digestibility of a New Formula in Healthy Infants
Lead Sponsor:
Lactalis
Conditions:
Steatorrhea
Growth
Eligibility:
All Genders
2-4 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01184378
Start Date
November 1 2008
End Date
January 1 2011
Last Update
January 26 2011
Active Locations (2)
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1
Faculté de Médecine
Dijon, France, 21078
2
Hopital Mère-Enfants
Rennes, France, 35000