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

Cow Milk Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940068
• Other study ID #: PRO-UP05-E1
• Status: Completed
• Phase: N/A
• First received: September 6, 2013
• Last updated: March 20, 2015
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: United Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cow Milk Allergy
• Milk Hypersensitivity

Intervention

Dietary Supplement:
• Amino acid based formula

Locations

Country	Name	City	State
France	Necker Children's Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
United Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of withdrawal for intolerance		1 month	Yes