An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy

NATerminatedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
AllergyFood Allergy
Interventions
OTHER

Special Medical Food

"Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months.~Infants should typically consume the following amounts of formula during the study \> 500mls/day up to 12 months of age \> 400mls/day between 12 and 18 months of age \> 300mls/day over 18 months of age."

OTHER

Special Medical Food

"Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months.~Infants should typically consume the following amounts of formula during the study \> 500mls/day up to 12 months of age \> 400mls/day between 12 and 18 months of age \> 300mls/day over 18 months of age."

Trial Locations (7)

53115

St.-Marien-Hospital, Bonn

75743

l'hôpital Necker Enfants malades, Paris

D-13353

Hospital Charité, Berlin

SO16 6YD

Southampton General Hospital, Southampton

PO30 5TG

David Hyde Allergy Clinic - St. Mary's hospital, Newport

SE1 7EH

Evelina Children's Hospital - St Thomas' Hospital, London

NE4 6BE

Newcastle general hospital, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Nutricia Research

INDUSTRY