- Egg Hypersensitivity
Conditions
Keywords
Egg allergy,specific oral tolerance induction
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
Interventions
OTHERSpecific oral tolerance induction
Specific oral tolerance induction consisted in the administration of increasing amounts of raw emulsion egg
Sponsors
Ospedale Buon Consiglio Fatebenefratelli
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* at least 1 anaphylactic reaction (grade 3, 4 and 5 according to Sampson's grading after accidental exposure to trace amounts of egg or egg-derivative products, requiring emergency treatment, at least 1 year before enrollment * demonstration of egg white specific IgE by the skin prick test (SPT), end-point SPT, raw egg white prick-by-prick (PP) and egg white-specific IgE determination * positive double-blind placebo-controlled food challenge (DBPCFC) at a dose of less than 0.9 ml of raw emulsion egg
Exclusion criteria
* age below 5 years * poorly controlled asthma * parents with a history of unreliable management of complications and treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP | 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. |
Countries
Italy
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Specific Oral Tolerance Induction Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen | 10 |
| Control controls were kept on an egg-free diet for 6 months | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Control | Specific Oral Tolerance Induction | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 7.676 years STANDARD_DEVIATION 3.203 | 7.033 years STANDARD_DEVIATION 1.768 | 7.354 years STANDARD_DEVIATION 2.607 |
| Region of Enrollment Italy | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 10 | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: baseline and 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Specific Oral Tolerance Induction | Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg | 9 participants |
| Control | Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg | 0 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.
Time frame: Baseline and 6 months
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Specific Oral Tolerance Induction | Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP | 5 mm diameter |
| Control | Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP | 10 mm diameter |