Efficacy of a New Thickened Extensively Hydrolyzed Formula (ALLAR)

United Pharmaceuticals

Status

Completed

Conditions

Cow's Milk Protein Hypersensitivity

Protein Allergy

Treatments

Dietary Supplement: Extensively hydrolysed formula

Dietary Supplement: new extensively hydrolysed formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT01985607

UP08-ALLAR

Details and patient eligibility

About

Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN) & the European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of distressed infants with reflux, suspected of CMA. One of the preferred proposed options is to thicken an extensive hydrolysate .

This study aims at evaluating the additional value of a thickened extensive hydrolysate in children suspected of CMA and presenting with frequent regurgitation.

Enrollment

72 estimated patients

Sex

All

Ages

Under 6 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

term born infants
Having a Vandenplas' score of regurgitation of at least 2
With suspected diagnosis of CMA because of clinical history/symptoms (based on a Cow's Milk Protein hypersensitivity (CMPH) score of 10 or more) and/or positive Immunoglobulin E (IgE) testing, radioallergosorbent test (RAST) or skin prick test

Exclusion criteria