Trial Outcomes & Findings for Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy (NCT NCT01379651)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2011-09-20

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Specific Oral Tolerance Induction Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen	Control controls were kept on an egg-free diet for 6 months
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Specific Oral Tolerance Induction n=10 Participants Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen	Control n=10 Participants controls were kept on an egg-free diet for 6 months	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	7.033 years STANDARD_DEVIATION 1.768 • n=5 Participants	7.676 years STANDARD_DEVIATION 3.203 • n=7 Participants	7.354 years STANDARD_DEVIATION 2.607 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Italy	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Specific Oral Tolerance Induction n=10 Participants Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen	Control n=10 Participants controls were kept on an egg-free diet for 6 months
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	0 participants

SECONDARY outcome

Timeframe: 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

Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.

Outcome measures

Outcome measures
Measure	Specific Oral Tolerance Induction n=10 Participants Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen	Control n=10 Participants controls were kept on an egg-free diet for 6 months
Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP	5 mm diameter Interval 4.0 to 13.0	10 mm diameter Interval 5.5 to 15.0

Adverse Events

Specific Oral Tolerance Induction

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Specific Oral Tolerance Induction n=10 participants at risk Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen	Control n=10 participants at risk controls were kept on an egg-free diet for 6 months
Immune system disorders Allergic reaction	100.0% 10/10 • Number of events 53 • 6 month	30.0% 3/10 • Number of events 5 • 6 month

Additional Information

Dr. Iride Dello Iacono

Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy

Phone: +39 824 771111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place