Althera® Versus Nutramigen / Cow's Milk Intolerance

Summary

The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in efficacy than NUTRAMIGEN®

Conditions

• Allergy

Interventions

OTHER

Infant Formula Feeding

Assigned formula (Althera® or Nutramigen®) for a 4 weeks period. * If the challenge is positive: The children continue the assigned formula * If the challenge is negative: A Follow up formula is given * (Nan pro2) if child \> 6 months * (Nan pro1) if child \< 6 months

Sponsors & Collaborators

• Société des Produits Nestlé (SPN)

  lead INDUSTRY

Principal Investigators

• Yvan Vandenplas, Professor · AZ-Kinderen V.U.B.

• Bruno Hauser, Doctor · AZ-Kinderen V.U.B.

• Thierry Devreker, Doctor · AZ-Kinderen V.U.B.

• Marc Verghote, Doctor · CHR Namur

• Christine Halut, Doctor · CHR Namur

• Olivia Bauraind, Doctor · Clinique Saint Pierre

• Sandra Mulier, Doctor · CHU des Enfants Reine Fabiola

• Pascal Lenoir, Doctor · Clinique Notre Dame Tournai

• Etienne Sokal, Professor · Clinique Universitaire Saint Luc

• Francoise Smets, Doctor · Clinique Universitaire Saint Luc

• Francoise Bury, Doctor · Clinique de l'Espérance

• Stéphanie Colinet, Doctor · Clinique de l'Espérance

• Stefaan Peeters, Doctor · Aalsters Stedelijk ziekenhuis

• Patrick Bollen, Doctor · AZ Vesalius

• Paul Mariën, Doctor · Sint Augustinus

• Gigi Veereman, Professor · Paola Kinderziekenhuis

• Myriam VanWinckel, Professor · UZ Gent

• Jozef Christens, Doctor · Maria Ziekenhuis Noord Limburg

• Kristien Kamoen, doctor · Algemeen Ziekenhuis Maria Middelares

• Michèle Scaillon, Doctor · CHU des Enfants Reine Fabiola

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2010-10-31

Completion

2011-07-31

Countries

• Belgium

Study Locations