Althera® Versus Nutramigen / Cow's Milk Intolerance | NCT01727115 | Trialant

Althera® Versus Nutramigen / Cow's Milk Intolerance | NCT01727115 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NUTRAMIGEN®	Active Comparator	Subjects are orally fed ad libitum (following guidelines printed on the labels). Subjects will receive the Nutramigen® formula for a 4 week period Then depending of the result of the challenge test we have the following possibilities: If the test is positive: The children continue the formula Nutramigen® If the test is negative: A Follow up formula is given (Nan pro2) if child > 6 months (Nan pro1) if child < 6 months	Other: Infant Formula Feeding
ALTHERA®	Experimental	Subjects are orally fed ad libitum (following guidelines printed on the labels). Subjects will receive the Althera® formula for a 4 week period Then depending of the result of the challenge test we have the following possibilities: If the test is positive: The children continue the formula Althera® If the test is negative: A Follow up formula is given (Nan pro2) if child > 6 months (Nan pro1) if child < 6 months	Other: Infant Formula Feeding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Infant Formula Feeding	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment.	regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms	4 weeks

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Yvan Vandenplas, Professor	AZ-Kinderen V.U.B.	Principal Investigator
Bruno Hauser, Doctor	AZ-Kinderen V.U.B.	Principal Investigator
Thierry Devreker, Doctor	AZ-Kinderen V.U.B.	Principal Investigator
Marc Verghote, Doctor	CHR Namur	Principal Investigator
Christine Halut, Doctor	CHR Namur	Principal Investigator
Olivia Bauraind, Doctor	Clinique Saint Pierre	Principal Investigator
Sandra Mulier, Doctor	CHU des Enfants Reine Fabiola	Principal Investigator
Pascal Lenoir, Doctor	Clinique Notre Dame Tournai	Principal Investigator
Etienne Sokal, Professor	Clinique Universitaire Saint Luc	Principal Investigator
Francoise Smets, Doctor

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23837862	Derived	Vandenplas Y, Steenhout P, Planoudis Y, Grathwohl D; Althera Study Group. Treating cow's milk protein allergy: a double-blind randomized trial comparing two extensively hydrolysed formulas with probiotics. Acta Paediatr. 2013 Oct;102(10):990-8. doi: 10.1111/apa.12349. Epub 2013 Aug 5.