A Phase 1/2 interventional study of Specific oral tolerance induction in - Egg Hypersensitivity, sponsored by Ospedale Buon Consiglio Fatebenefratelli. Completed at 1 site in Italy. Open to participants aged 5 Years to 11 Years. Per ClinicalTrials.gov, last updated 2011-09-20.
Sponsored by Ospedale Buon Consiglio Fatebenefratelli · Phase 1/2, Interventional, and Treatment
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.
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
38 studies on the registry are indexed under Egg Hypersensitivity; 9 are open to participants now.
This study's enrollment of 20 is below the median of 73 across 27 interventional studies indexed under Egg Hypersensitivity.
Browse Egg Hypersensitivity studies →Ospedale Buon Consiglio Fatebenefratelli is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
Other: Specific oral tolerance induction
controls were kept on an egg-free diet for 6 months
Specific oral tolerance induction consisted in the administration of increasing amounts of raw emulsion egg
Also known as: SOTI
Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg
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
Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP
Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.
Time frame: Baseline and 6 months
26 children (14 boys, 12 girls; median age: 7 years 7 months; range 5-11 years), with severe IgE-mediated egg allergy (EA) were recruited from the Pediatric and Allergology Unit of the Fatebenefratelli Hospital in Benevento, Italy, from January 2008 to December 2009.
| Milestone | Specific Oral Tolerance Induction | Control |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| participants | Specific Oral Tolerance Induction | Control |
|---|---|---|
| Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg | 9 | 0 |
Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.
| mm diameter | Specific Oral Tolerance Induction | Control |
|---|---|---|
| Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP | 5 (4 to 13) | 10 (5.5 to 15) |
Collected over 6 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Specific Oral Tolerance Induction | — | 0/10 (0%) | 10/10 (100%) |
| Control | — | 0/10 (0%) | 3/10 (30%) |
| Event | Specific Oral Tolerance Induction | Control |
|---|---|---|
| Allergic reactionImmune system disorders | 10/10 | 3/10 |
| Age, Categorical(Participants) | Specific Oral Tolerance Induction | Control | Total |
|---|---|---|---|
| <=18 years | 10 | 10 | 20 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Specific Oral Tolerance Induction | Control | Total |
|---|---|---|---|
| Mean | 7.033 ± 1.768 | 7.676 ± 3.203 | 7.354 ± 2.607 |
| Sex: Female, Male(Participants) | Specific Oral Tolerance Induction | Control | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 5 | 5 | 10 |
| Region of Enrollment(participants) | Specific Oral Tolerance Induction | Control | Total |
|---|---|---|---|
| Italy | 10 | 10 | 20 |
The record gives a start of Jan 2008, a primary completion of Jun 2010 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2011, 1 year 2 months after primary completion.
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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Ospedale Buon Consiglio Fatebenefratelli