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

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. Identifier: NCT01379651
Recruitment Status : Completed
First Posted : June 23, 2011
Results First Posted : August 30, 2011
Last Update Posted : September 20, 2011
Information provided by (Responsible Party):
Iride Dello Iacono, Ospedale Buon Consiglio Fatebenefratelli

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

  Baseline Characteristics

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
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 
[Units: Participants]
<=18 years   10   10   20 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 7.033  (1.768)   7.676  (3.203)   7.354  (2.607) 
[Units: Participants]
Female   5   5   10 
Male   5   5   10 
Region of Enrollment 
[Units: Participants]
Italy   10   10   20 

  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

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