Early Oral Immunotherapy in Infants With Cow's Milk Protein Allergy

IRCCS Burlo Garofolo

Status: Completed

Conditions: Hypersensitivity, Milk

Treatments: Other: Oral immunotherapy protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03586388

RC 18/12

Details and patient eligibility

About

Cow's milk (CM) allergy is the most frequent food allergy in the first years of life, with prevalence rates estimated in the range of 2-3%.

The elimination of CM is the mainstay of treatment, but accidental exposure to CM proteins is not uncommon, with a considerable risk of severe allergic reactions.

Recent evidence suggests that early oral exposure in young children may protect to the development of allergy. On the same way, strategies have been developed for the use of oral exposure as immunotherapy for the treatment of children with established food allergy even if available data on the use of oral immunotherapy in infants with food allergy are very limited.

The aim of this study is to evaluate the feasibility of an oral immunotherapy protocol, started in the first year of life, in children with CM allergy.

Enrollment: 73 patients

Sex: All

Ages: 3 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children between 3-12 months with CM allergy (defined as the association of typical clinical manifestations in the first hour after CM ingestion and evidence of sensitization of CM proteins on both skin prick test and specific serum IgE levels)

Exclusion criteria

• children with not IgE-mediated clinical manifestations
• children with a known immunodeficiency

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Oral immunotherapy protocol

Experimental group

Description:

Eligible children receive the oral food challenge (OCD) protocol

Treatment:

Other: Oral immunotherapy protocol