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

Pilot Study on the Efficacy and Safety of an Oral Desensitization Protocol at the Onset of Food Allergy

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.

Study Overview

• Status: Completed
• Conditions: Hypersensitivity, Milk
• Intervention / Treatment: Other: Oral immunotherapy protocol

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Trieste, Italy, 34137
    • Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Oral immunotherapy protocol; Eligible children receive the oral food challenge (OCD) protocol

Other: Oral immunotherapy protocol; In hospital setting: three increasing doses every 30 minutes of 1ml, 5ml and 10ml of cow milk (CM). Oral food challenge (OFC) stopped at 10ml even if no clinical reactions occurred. At home: every child will take the dose tolerated in hospital, starting the day after the OFC, for 3-4 weeks.Once reached the dose of 40ml of CM without reactions for at least 2 weeks, families increment the dose of 5 ml every week, till the tolerance of 50 ml, then of 10 ml every week, till the tolerance of 100ml and then, of 10 ml every 3 days till the tolerance of 150 ml of milk.; Other Names: Oral food challenge (OCD)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Principal Investigator: Laura Badina, Md, IRCCS Burlo Garofolo; Study Chair: Giorgio Longo, MD, IRCCS Burlo Garofolo; Study Director: Egidio Barbi, MD, IRCCS Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Immunotherapy; Infant; Cow's Milk; Hypersensitivity, Milk
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: RC 18/12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No