Unit of Pediatrics, Fatebenefratelli Hospital
Benevento, 82100, Italy
NCT Number: NCT01379651
To evaluate the efficacy of a 6-month specific oral tolerance induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.
Looking for future studies?
Notify Me5 year–11 year
All sexes
Interventional
Phase 1 / Phase 2
Benevento, 82100, Italy
Oral immunotherapy consisted in the administration of increasing amounts of raw emulsion egg. The children started with 1 drop of undiluted raw egg emulsion (0.05 ml) flavored with vanilla and cacao, hidden by the parents in the child's breakfast (cow's milk, soymilk, fruit juice or other). The dose was doubled at intervals of about one month in the day hospital. The increases in dose were customized for each subject based on the frequency and severity of side effects, or when an inter-current illness or asthma worsening intervened during the SOTI.
The investigators limited the SOTI protocol to six months for all patients, irrespective of the dose reached, in order to favor the adherence of families to the study.
When objective symptoms seemed more important (grade 2, 3 and 4 reaction), medical treatment was given. Subjects were discontinued from the study in case of severe adverse reactions (grade 5 reaction). Parents were advised they could telephone investigators 24 hours a day
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specific oral tolerance induction consisted in the administration of increasing amounts of raw emulsion egg
Other names: SOTI
Time frame: baseline and 6 months
To evaluate the efficacy of a 6-month Specific Oral Tolerance Induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated after 6 months) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.
Time frame: Baseline and 6 months
Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.
Ospedale Buon Consiglio Fatebenefratelli
Other
Specific Oral Tolerance Induction in Children With Severe Egg Allergy: A Randomized Controlled Trial Using a 6 Months Protocol
Acronym: EGGSOTI
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.
Published trials that share one or more normalized conditions with this study.
NCT07192510
Egg Allergy, Egg Hypersensitivity
Singapore
View Trial DetailsNCT04856865
Egg Hypersensitivity, Food Allergy
Mission Viejo, California, United States
View Trial DetailsNCT04839666
Allergy, Egg, Egg Hypersensitivity
Jette, Brussels Capital, Belgium
View Trial DetailsNCT01822353
Egg Hypersensitivity, Food Allergy
Helsinki, Finland
View Trial Details