Frequently Asked Questions

What is the purpose of the study?
In this study, we wish to determine whether we can prevent the development of allergy and asthma in high-risk children by using oral mucosal immunoprophylaxis
 

Who can participate?
Participation is voluntary. Children aged between 18-30 months who have eczema, a food allergy and a family history of eczema, allergies and/or asthma. Additional criteria can be obtained by contacting the study coordinator at your closest clinical centre.
 

How are the study medicine drops administered?
The drops will be administered under the tongue via a specially designed spoon every day for 12 months. The first dose of study medication will be given under observation at the clinical centre. You will receive instructions on how to administer the drops.

How often do I need to visit the clinic and how long will

these visits take?
Seven times during 12 months and six visits over the following 3 years. Each visit will take between 1-2 hours, depending on which tests are required for that particular visit .

When are the clinical centres open for study visits?
Each clinical centre has different hours, however, every attempt has been made to be flexible in order to accommodate working parents.
 

Will I or my child receive payment for participating?
No, neither you nor your child will receive any payment for taking part in this study.
 

What is the purpose of laboratory tests to be performed?
The laboratory tests serve several purposes. Initial tests may be required to determine your child’s eligibility. Subsequent tests performed during the course of the trial will be used to assess how your child’s immune cells respond to specific allergens and to evaluate the impact of the preventative treatment.
 

How will my privacy be protected?
The ITN and its partner clinical sites take the privacy of study participants very seriously. The confidentiality of all patient records is maintained according to regulations set by the participant’s country of origin. The results of all tests, assessments and evaluations performed during the course of the study will remain confidential and will not be released to third parties without prior written consent of the participant and/or guardian. Prior to publication or dissemination of the study results, all personal identifying information will be removed.
 

What are the potential benefits of participating?
Potential to decrease your child’s risk of developing asthma and allergies.
 

Are there any risks to my child in participating in

the GPAC Study?
As with any medical treatment, there are risks involved, both known and unknown. Known side-effects of the treatment are related to allergic responses to the allergens in the treatment mix. Your child may experience some oral or sub-lingual itching. There may also be some non-specific gastro-intestinal side-effects like nausea, vomiting or abdominal pain. Study staff will discuss the potential risks with you and answer any questions you may have before deciding to enroll your child into the study.