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

United Pharmaceuticals

Status: Completed

Conditions: Cow Milk Allergy

Treatments: Dietary Supplement: Amino acid based formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01940068

PRO-UP05-E1

Details and patient eligibility

About

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;

Enrollment: 86 patients

Sex: All

Ages: 2 weeks to 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

86 participants in 2 patient groups

New Thickened Amino acid based formula

Experimental group

Treatment:

Dietary Supplement: Amino acid based formula

Amino acid based formula

Active Comparator group

Treatment:

Dietary Supplement: Amino acid based formula