Tolerance and Digestibility of a New Formula in Healthy Infants

Phase 2

Completed

• Conditions: Steatorrhea; Growth
• Interventions: Dietary Supplement: dairy lipids and soluble milk proteins

• 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

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-18
• Primary Completion: 2010-12
• Status Verified: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-26

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

Arm && Interventions

Group	Intervention	Description
control formula	dairy lipids and soluble milk proteins	formula containing only vegetable fats
new formula	dairy lipids and soluble milk proteins	new formula with dairy lipids and soluble milk proteins

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)

Hopital Mère-Enfants; 🇫🇷 Rennes, France

Faculté de Médecine; 🇫🇷 Dijon, France