NCT01526863

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

January 30, 2012

Last Update Submit

January 15, 2015

Conditions

Allergy

Keywords

AllergyEgg

Outcome Measures

Primary Outcomes (1)

  • positive or negative result (objective and subjective symptoms) of a challenge test with egg

    6 months

Secondary Outcomes (4)

  • 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

    6 months

  • Morbidity / Adverse Events

    6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: HA egg

HA egg

ACTIVE COMPARATOR
Dietary Supplement: HA egg

Interventions

HA eggDIETARY_SUPPLEMENT

Daily dose of HA egg or placebo for 6 months

HA eggPlacebo

Eligibility Criteria

Age12 Months - 66 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Athens

Athens, 11527, Greece

Location

University Hospital of Padua

Padua, 35128, Italy

Location

Hochgebirgsklinik Davos

Wolfgang, 7265, Switzerland

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 6, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

January 16, 2015

Record last verified: 2015-01

Locations

GR(1)IT(1)CH(1)