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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific oral tolerance induction | Experimental | Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen |
|
| control | No Intervention | controls were kept on an egg-free diet for 6 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific oral tolerance induction | Other | Specific oral tolerance induction consisted in the administration of increasing amounts of raw emulsion egg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iride Dello Iacono, pediatrician | Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Pediatrics, Fatebenefratelli Hospital | Benevento | Benevento | 82100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20355360 | Background | Calvani M, Giorgio V, Miceli Sopo S. Specific oral tolerance induction for food. A systematic review. Eur Ann Allergy Clin Immunol. 2010 Feb;42(1):11-9. | |
| 12777599 | Background | Sampson HA. Anaphylaxis and emergency treatment. Pediatrics. 2003 Jun;111(6 Pt 3):1601-8. |
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6 children(4 males and 2 females)were excluded from the study: one child because the parents had a history of unreliable management of complications and treatments;2 children because of poorly controlled asthma;3 children because of a positive double-blind placebo-controlled food challenge (DBPCFC) at a dose of raw egg emulsion higher than 0.9 ml.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Specific Oral Tolerance Induction | Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen |
| FG001 | Control | controls were kept on an egg-free diet for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Specific Oral Tolerance Induction | Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen |
| BG001 | Control | controls were kept on an egg-free diet for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | baseline and 6 months |
|
6 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Specific Oral Tolerance Induction | Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | allergic reaction | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Iride Dello Iacono | Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy | +39 824 771111 | iridedello@hotmail.com |
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| ID | Term |
|---|---|
| D021181 | Egg Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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|
| 16455349 | Background | Sicherer SH, Sampson HA. 9. Food allergy. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S470-5. doi: 10.1016/j.jaci.2005.05.048. |
| 19076011 | Background | Barbi E, Berti I, Longo G. Food allergy: from the of loss of tolerance induced by exclusion diets to specific oral tolerance induction. Recent Pat Inflamm Allergy Drug Discov. 2008 Nov;2(3):212-4. doi: 10.2174/187221308786241875. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | We were unable to calculate sample size because no quantitative data about the clinical outcome could be hypothesized. Indeed, the few reports of food causing allergy, the protocol, the way of SOTI administration and food doses administered yielded reported variable results. the analysis was per intention to treat | Posted | Median | Full Range | mm diameter | Baseline and 6 months |
|
|
|
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | Control | controls were kept on an egg-free diet for 6 months | 0 | 10 | 3 | 10 |
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