Certain babies are at a higher risk of developing allergic diseases like atopic dermatitis (allergic eczema), food allergy, asthma, and allergic rhinitis (hay fever). Familial history of allergic diseases, meaning having a mom, dad, or blood-related sibling with these diseases, has been associated with a higher risk of developing these conditions that can significantly affect a child’s life. Currently, there are no approved treatments to prevent allergic diseases from happening.
There is new research happening in multiple research sites across the US, evaluating whether allergies can be prevented by enhancing a baby’s gut microbiome with the introduction of good bacteria found in babies with strong gut microbiomes.
The ADORED study involves investigating strengthening gut immunity and in turn, preventing allergic disease development. Researchers aim to understand if a live biotherapeutic, taken early in life could prevent the onset of allergic disease among newborns with a family history of having an allergic disease.
Several studies have shown that the lack of certain microbes in the gut may be associated with the development of allergic diseases, including atopic dermatitis, food allergy, asthma, and allergic rhinitis. The goal of the ADORED Study is to test if STMC-103H, an investigational probiotic-based treatment consisting of a consortium of commensal microbes, can prevent newborns from developing allergic diseases in the first place.
“Our approach is novel because it targets the underlying cause of disease and through early intervention, we aim to alleviate multiple allergic diseases that share a common immune dysregulation. Considering the growing health and cost burdens associated with allergic diseases in the US and globally, our success here would help address a large unmet clinical need and alleviate life-long suffering in many individuals. It is a bold mission and one that could have a tremendous positive impact on society,” says Dr. Nikole Kimes, CEO of Siolta Therapeutics.
This study is looking at whether the treatment may prevent atopic dermatitis (eczema), food allergy, asthma, and allergic rhinitis (hay fever). STMC-103H is an investigational live bacterial product (LBP) which is made of naturally occurring bacteria that may be important for human gut health. STMC-103H is not an over-the-counter probiotic – but is regulated by the FDA as a drug. LBPs are required to show safety and effectiveness through regulated clinical trials and are manufactured at the highest levels of quality.
Families interested in enrolling their newborn in the study should visit the study website www.adoredstudy.com or clinicaltrials.gov (clinicaltrials.gov/study/NCT05003804) to confirm they meet the eligibility criteria to participate, as listed below:
- The child’s birth parent(s) or legal representative is 18 years of age or older.
- Child is ≤ 14 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).
If a newborn meets the eligibility criteria, they should reach out to one of the participating clinical trial sites directly for more information. The list of participating clinical trial sites can be found at https://www.adoredstudy.com or at clinicaltrials.gov.
