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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01379651
First Posted: June 23, 2011
Last Update Posted: September 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Iride Dello Iacono, Ospedale Buon Consiglio Fatebenefratelli
Results First Submitted: June 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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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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.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
No text entered.


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


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
First Submitted: June 20, 2011
First Posted: June 23, 2011
Results First Submitted: June 24, 2011
Results First Posted: August 30, 2011
Last Update Posted: September 20, 2011