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

NCT03586388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2018-07-16

No results posted yet for this study

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.

Conditions

  • Hypersensitivity, Milk

Interventions

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.

Sponsors & Collaborators

  • IRCCS Burlo Garofolo

    lead OTHER

Principal Investigators

  • Laura Badina, Md · IRCCS Burlo Garofolo

  • Giorgio Longo, MD · IRCCS Burlo Garofolo

  • Egidio Barbi, MD · IRCCS Burlo Garofolo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-12-31
Completion
2017-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03586388 on ClinicalTrials.gov