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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Page 1 of 1 (2 locations)

1

Faculté de Médecine

Dijon, France, 21078

2

Hopital Mère-Enfants

Rennes, France, 35000