Tolerance and Digestibility of a New Formula in Healthy Infants

Growth Clinical Trial

Official title:

Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184378
• Other study ID #: LRD-08-15
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2010
• Last updated: January 25, 2011
• Start date: November 2008
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Lactalis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 4 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Growth
• Steatorrhea

Intervention

Dietary Supplement:
• dairy lipids and soluble milk proteins
one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake

Locations

Country	Name	City	State
France	Faculté de Médecine	Dijon
France	Hopital Mère-Enfants	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Lactalis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	digestibility of lipids in formula	lipid content determination in feces during a 3 days period of collection after 15d and 30d of formula intake	during the 30d consumption period	No
Secondary	tolerance and growth		during the 30d of formula intake	No