Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT01379651
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2011-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy
Sponsor:
Ospedale Buon Consiglio Fatebenefratelli
Organization:
Study Overview
Official Title:
Specific Oral Tolerance Induction in Children With Severe Egg Allergy: A Randomized Controlled Trial Using a 6 Months Protocol
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EGGSOTI
Brief Summary:
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.
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: