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
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


  Baseline Characteristics
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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.
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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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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