NCT03586388

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 3 Months – 12 Months
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-12-01
• Completion: 2017-06-01
• First posted: 2018-07-13
• Last updated: 2018-07-16

Locations

1 site across 1 country: Italy