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Completed

NCT Number: NCT03586388

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

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Key information

Conditions

Hypersensitivity, Milk Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, 34137, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral immunotherapy protocol

Other

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)

Primary outcomes

  1. number of children that completed the home oral immunotherapy protocol, reaching clinical tolerance

    Time frame: 6 months

    Clinical tolerance defined as the achievement of a dose of 150 ml of CM or a corresponding dose of dairy products

Secondary outcomes

  1. Clinical reactions experienced by children at home

    Time frame: 6 months

    Number and types, communicated by parents at a dedicated telephone number.

  2. Serum levels of specific IgE

    Time frame: 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

  3. Serum levels of specific IgG4

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 13, 2018
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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