Trial | NCT01940068  Report issue

Official Title

A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    amino acids ...

  • Study Participants

    86
The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;
Study Started
Mar 31
2011
Primary Completion
Jul 31
2013
Study Completion
Dec 31
2013
Last Update
Mar 24
2015
Estimate

Dietary Supplement Amino acid based formula

New Thickened Amino acid based formula Experimental

Amino acid based formula Active Comparator

Criteria 

Inclusion Criteria:

less than 18 months old
with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (>=6mm) or specific immunoglobulin E >= 5 kilo-unit/L or combination
still symptomatic while fed an extensively hydrolysed formula

Exclusion Criteria:

Exclusively breast fed infants
non allergic digestive enteropathy
No Results Posted