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

Hypersensitivity, Milk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586388
• Other study ID #: RC 18/12
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2018
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Hypersensitivity, Milk
• Milk Hypersensitivity

Intervention

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.

Locations

Country	Name	City	State
Italy	Institute for Maternal and Child Health - IRCCS Burlo Garofolo-	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical reactions experienced by children at home	Number and types, communicated by parents at a dedicated telephone number.	6 months
Secondary	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
Secondary	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