Tolerance and Digestibility of a New Formula in Healthy Infants
Phase 2
Completed
- Conditions
- SteatorrheaGrowth
- Registration Number
- NCT01184378
- Lead Sponsor
- Lactalis
- 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 the nutritional composition of maternal milk.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method digestibility of lipids in formula during the 30d consumption period lipid content determination in feces during a 3 days period of collection after 15d and 30d of formula intake
- Secondary Outcome Measures
Name Time Method tolerance and growth during the 30d of formula intake
Trial Locations
- Locations (2)
Faculté de Médecine
🇫🇷Dijon, France
Hopital Mère-Enfants
🇫🇷Rennes, France
Faculté de Médecine🇫🇷Dijon, France