Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy (RAF)

Laboratorios Ordesa

Status

Completed

Conditions

Cow's Milk Allergy

Treatments

Other: Commercially available Amino Acid Formula

Other: New Amino Acid formula

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02414243

RAF-01-015

Details and patient eligibility

About

This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged< 12 years with documented cow's milk protein allergy (CMPA).

Full description

Not Provided

Enrollment

41 patients

Sex

All

Ages

Under 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2):
- Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow's milk OR
- Positive open or single-blind oral food challenge with cow's milk carried out under the supervision of a specialist in children with clear immediate reactions and a positive test for specific IgE (in serum [sIgE>0,35 KUI/L] or skin prick test [SPT ≥ 3 mm]) OR
- Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE or positive skin prick test
Aged ≤12 years of age at screening.
Expected consumption of a minimum of 250ml of study formula per day during the open challenge.
Written informed consent from one or both parents (depending on the local legislation) or legal representative.

Exclusion criteria

Children who receive breastfeeding at study enrolment.
Had any chronic medical diseases, chromosomal or major congenital anomalies, or major gastrointestinal disease/abnormalities (other the CMPA); had immunodeficiency; antihistamine [excluding eye drops] use in 7 days prior to a food challenge or oral steroid use within 14 days prior to enrolment; unstable asthma; severe uncontrolled eczema;
Severe anaphylactic reaction [required ≥ 2 doses of epinephrine] to milk or breast milk within the past 2 years;
Existing illness that could interfere with formula acceptance or identification of allergic reactions.
Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.