Hydrolyzed Egg and Tolerance Induction | NCT01526863

Studies
Hydrolyzed Egg and Tolerance Induction

NCT01526863

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Jan 16, 2015Estimated

Enrollment

29Actual

Phase

Not Applicable

Conditions

Allergy

Interventions

HA egg

Countries

Greece
Italy
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jan 30, 2012

First Submission Date that Met QC Criteria

Feb 3, 2012

First Posted Date

Feb 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2015

Last Update Posted Date

Jan 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this trial is to assess the effect of hydrolyzed egg orally administered on oral tolerance induction to egg in children allergic to egg as compared to a placebo.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Dietary Supplement: HA egg
HA egg	Active Comparator		Dietary Supplement: HA egg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HA egg	Dietary Supplement	Daily dose of HA egg or placebo for 6 months	HA egg Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
positive or negative result (objective and subjective symptoms) of a challenge test with egg		6 months

Secondary Outcomes

Measure	Description	Time Frame
compliance (product taken)		6 months
skin prick test (sensitization to egg; size of wheal and flare)		6 months
Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Child of any ethnicity aged between 12 and 66 months at the time of enrolment
- Positive Skin Prick Test (SPT) to egg white within the last 3 months
- Either positive oral challenge OR convincing history, defined as an immediate (<1h) reaction following isolated ingestion of egg, positive SPT to egg white and positive sIgE (> 0.35 kU/L) for at least one of the following: egg, egg white, ovalbumin, ovomucoid, within the last 12 months
- Having obtained his/her signed legal representative's informed consent.

Exclusion Criteria:

History of severe anaphylaxis to egg
- Significant pre-natal and/or post-natal disease
- Child on systemic drugs (e.g. antihistamines, beta-agonists, ACE-inhibitors) according to half-life at time of enrolment
- Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
- Child whose parents / caregivers cannot be expected to comply with treatment
- Child currently participating in another interventional clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

66 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nikolaos Papadopoulos, Prof.	University of Athens, Greece	Study Chair
Antonella Muraro, Prof	University Hospital of Padua, Italy	Principal Investigator
Roger Lauener, Prof.	Hochgebirgsklinik Davos, Switzerland	Principal Investigator
Stavroula Giavi, Dr.	University of Athens, Greece	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Athens		Athens		11527	Greece
University Hospital of Padua