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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iride Dello Iacono, Ospedale Buon Consiglio Fatebenefratelli
ClinicalTrials.gov Identifier:
NCT01379651
First received: June 20, 2011
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
Results First Received: June 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: - Egg Hypersensitivity
Intervention: Other: Specific oral tolerance induction

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Specific Oral Tolerance Induction     Control  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Specific Oral Tolerance Induction     Control     Total  
Number of Participants  
[units: participants]
 		  10     10     20  
Age  
[units: participants]
 		     
<=18 years     10     10     20  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  7.033  ± 1.768     7.676  ± 3.203     7.354  ± 2.607  
Gender  
[units: participants]
 		     
Female     5     5     10  
Male     5     5     10  
Region of Enrollment  
[units: participants]
 		     
Italy     10     10     20  



  Outcome Measures
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1.  Primary:   Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg   [ Time Frame: baseline and 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP   [ Time Frame: Baseline and 6 months ]
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Measure Type Secondary
Measure Title Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP
Measure Description 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
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

Measured Values
    Specific Oral Tolerance Induction     Control  
Number of Participants Analyzed  
[units: participants]
 		  10     10  
Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP  
[units: mm diameter]
Median ( Full Range ) 		  5  
  ( 4 to 13 )   		  10  
  ( 5.5 to 15 )  

No statistical analysis provided for Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Iride Dello Iacono
Organization: Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy
phone: +39 824 771111
e-mail: iridedello@hotmail.com


Publications:


Responsible Party: Iride Dello Iacono, Ospedale Buon Consiglio Fatebenefratelli
ClinicalTrials.gov Identifier: NCT01379651     History of Changes
Other Study ID Numbers: FBFBN
Study First Received: June 20, 2011
Results First Received: June 24, 2011
Last Updated: September 19, 2011
Health Authority: Italy: National Institute of Health