AllergyNCT01526863
Hydrolyzed Egg and Tolerance Induction
A study testing HA egg in people with Allergy, run by Société des Produits Nestlé (SPN) at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 66 months
- Conditions the study is for
- Allergy
- What is being tested?
- HA egg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 66 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Assessment of the Effect of an HA Egg Administration for 6 Months on the Tolerance Induction to Egg in Children Allergic to Egg as Compared to a Placebo
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.
- Conditions
- Allergy
- Being tested
- HA egg
- Keywords
- Allergy, Egg
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA eggDietary supplement
Daily dose of HA egg or placebo for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: HA egg |
| HA egg | Active comparator | Not described Receives: Dietary Supplement: HA egg |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive or negative result (objective and subjective symptoms) of a challenge test with egg
Measured: 6 months
Secondary outcomes (4)
compliance (product taken)
Measured: 6 months
skin prick test (sensitization to egg; size of wheal and flare)
Measured: 6 months
Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation
Measured: 6 months
Morbidity / Adverse Events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikolaos Papadopoulos, Prof., Study chair, University of Athens, GreeceAntonella Muraro, Prof, Principal investigator, University Hospital of Padua, ItalyRoger Lauener, Prof., Principal investigator, Hochgebirgsklinik Davos, SwitzerlandStavroula Giavi, Dr., Principal investigator, University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526863
- Sponsor's protocol ID
- 10.53.NRC
- Status last verified
- Jan 2015
- First submitted
- 30 Jan 2012
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of an HA Egg Administration for 6 Months on the Tolerance Induction to Egg in Children Allergic to Egg as Compared to a Placebo
- ClinicalTrials.gov ID
- NCT01526863
- Acronym / sponsor ID
- 10.53.NRC
- Conditions
- Allergy
- Keywords
- Allergy, Egg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: HA egg |
| HA egg | Active comparator | Dietary Supplement: HA egg |
Who may qualify
- Ages
- 12 to 66 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child of any ethnicity aged between 12 and 66 months at the time of enrolment
Key exclusion criteria (6 listed)
- History of severe anaphylaxis to egg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HA eggDaily dose of HA egg or placebo for 6 months | Dietary supplement | HA egg, Placebo |
Primary outcome
positive or negative result (objective and subjective symptoms) of a challenge test with egg
Time frame: 6 months
4 secondary outcomes
compliance (product taken)
Time frame: 6 months
skin prick test (sensitization to egg; size of wheal and flare)
Time frame: 6 months
Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation
Time frame: 6 months
Morbidity / Adverse Events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Papadopoulos, Prof. study chair
University of Athens, Greece
Antonella Muraro, Prof principal investigator
University Hospital of Padua, Italy
Roger Lauener, Prof. principal investigator
Hochgebirgsklinik Davos, Switzerland
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HA egg in people with Allergy, run by Société des Produits Nestlé (SPN) at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive or negative result (objective and subjective symptoms) of a challenge test with egg (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.