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

NACompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

December 31, 2016

Study Completion Date

June 30, 2017

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."

Trial Locations (1)

34137

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

All Listed Sponsors
lead

IRCCS Burlo Garofolo

OTHER

NCT03586388 - Early Oral Immunotherapy in Infants With Cow's Milk Protein Allergy | Biotech Hunter | Biotech Hunter