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

Not Applicable

Completed

• Conditions: Hypersensitivity, Milk
• Interventions: Other: Oral immunotherapy protocol

• Registration Number: NCT03586388
• Lead Sponsor: IRCCS Burlo Garofolo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-12
• Study Completion: 2017-06
• Status Verified: 2018-07
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-13
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral immunotherapy protocol	Oral immunotherapy protocol	Eligible children receive the oral food challenge (OCD) protocol

Primary Outcome Measures

Name	Time	Method
number of children that completed the home oral immunotherapy protocol, reaching clinical tolerance	6 months	Clinical tolerance defined as the achievement of a dose of 150 ml of CM or a corresponding dose of dairy products

Secondary Outcome Measures

Name	Time	Method
Clinical reactions experienced by children at home	6 months	Number and types, communicated by parents at a dedicated telephone number.
Serum levels of specific IgE	6 months	Comparison in serum levels of specific IgE between baseline and the end of the protocol, hypothesizing a decrease of IgE levels after OFC
Serum levels of specific IgG4	6 months	Comparison in serum levels of specific IgG4 between baseline and the end of the protocol, hypothesizing an increase of IgG4 levels after OFC

Trial Locations

Locations (1)

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-; 🇮🇹 Trieste, Italy