What if a baby is more prone to getting allergies because of poor gut immunity? An infant allergy development prevention research study is being done across Australia and the United States with researchers looking into potential options that could prevent allergy development among children.
Improving the understanding between gut immunity and allergic diseases could pave the way for better approaches to reduce eczema, food allergy, asthma and other allergic diseases.
Called The ADORED Study, the trial involves testing an investigational product to potentially strengthen gut immunity and in turn, prevent allergic disease development. If you have a history of allergy in your family in your family and have a newborn, you could be eligible to be involved.
Why participate in the ADORED Study?
Parents living with allergies know how debilitating this condition is and how there is no known preventative care option available. Recent research has shown that there may be a link between gut immunity and allergy development. Researchers want to further look into this and understand how they can create options that might benefit millions of babies around the world.
Studies have found that the type of bacteria in the human gut during infancy may be able to reprogram the infant’s developing immune system. This study focuses on the science behind decoding early-life microbial intervention and whether administration of specific, naturally-occurring bacteria to infants may help prevent allergic diseases in newborns who are at risk for developing allergic diseases later in life.
By participating in the ADORED Study, you and your child will be contributing valuable information that may benefit other children in the future.
The investigational product is being tested to learn if it may help prevent the development of allergic disease in your child.
What will the ADORED Study entail?
The study team will explain the research study in its entirety to potential participants, but some details include:
- Some sites will offer for select study visits to be completed at home (Home Healthcare Visits).
- Siolta Therapeutics is sponsoring this research study, testing an investigational product that may prevent atopic dermatitis (eczema), food allergy, asthma and allergic rhinitis (hay fever). This potential treatment is an oral capsule containing power that will be mixed with a small amount of breastmilk, formula or milk product to be given to the child.
- This product is investigational, which means that it is not yet approved for use outside of research studies like this one.
Are you eligible to participate in the ADORED study?
To potentially qualify for the ADORED study, your newborn must meet all of the following initial eligibility requirements:
- The child’s birth parent(s) or legal representative is 18 years of age or older.
- Child is < 7 days of age. If the child’s mother is in her 2nd or 3rd trimester, the clinical site would like to obtain her parental consent for her child’s participation. This consent will be reconfirmed upon the child’s birth.
- The child’s biological mother, biological father and/or any full sibling has one or more of the following conditions: asthma, atopic dermatitis (allergic eczema), food allergy, or allergic rhinitis (hay fever, nasal allergies).
- The baby has not been given any probiotics (including formula containing probiotics) since the time of birth and the child’s birth parent(s) or legal guardian do not plan to give probiotics to the baby during the entire study.
- The baby is generally healthy, was not born prematurely (no less than 35 weeks gestation), and had an average birth weight (no less than 2.5 kg/5.5 lbs and no more than 4.5 kg/9.9 lbs).
- The primary caregiver of the child and the child must be able to commit to this research study for over approximately 2 years.
For more information on The ADORED study: