NCT03586388|Completed
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
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Pilot Study on the Efficacy and Safety of an Oral Desensitization Protocol at the Onset of Food Allergy
Sponsor study identifier
interventional
73
1 country
1
Study Start
March 2015
Actual (reported)Primary Completion
December 2016
Actual (reported)Study Completion
June 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Actual (reported)December 2016
Actual (reported)June 2017
Actual (reported)July 2, 2018
Actual (reported)July 13, 2018
Actual (reported)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
Clinical reactions experienced by children at home
6 months
Serum levels of specific IgE
6 months
Serum levels of specific IgG4
6 months
Eligible children receive the oral food challenge (OCD) 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Trieste, 34137, Italy
Laura Badina, Md
IRCCS Burlo Garofolo
Giorgio Longo, MD
IRCCS Burlo Garofolo
Egidio Barbi, MD
IRCCS Burlo Garofolo
73 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2018
First Posted
July 13, 2018
Study Start
March 2015
Actual (reported)Primary Completion
Tolerability and Safety of An Infant Formula
Contact the study team to confirm eligibility.
December 2016
Actual (reported)Study Completion
June 2017
Actual (reported)Last Updated
July 16, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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