Tuesday, July 11, 2023

Healthy Habits - Adored Study

 Poopy babies are needed to help other babies affected by allergic diseases like atopic dermatitis (allergic eczema), food allergy, asthma, and allergic rhinitis (hay fever). 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 changing a baby’s gut microbiome with those 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.

This study is looking at whether an investigational probiotic-based treatment by Siolta Therapeutics may prevent atopic dermatitis (eczema), food allergy, asthma, and allergic rhinitis (hay fever). This potential treatment called 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.

Although over-the-counter probiotics and LBPs are both made of living bacterial cells, over-the-counter probiotics are regulated as foods and do not require evidence of benefit or rigorous manufacturing controls. LBPs are required to show safety and effectiveness through regulated clinical trials and are manufactured at the highest levels of quality.

I had a chance to learn more in this interview.

  1. What Is the potential relationship between the gut biome and allergies?

Our bodies contain a large collection of bacteria, fungi, viruses, and other microbes together called the microbiome. In fact, we have at least as many microbial cells as we do human cells, and more importantly those microbial cells contribute more than 100X the number of genes to our human system than our own genome. Most human-associated bacteria are beneficial and contribute to a myriad of human functions, including providing nutrients for our cells through digestion and metabolism, programming the immune system, and preventing colonization by harmful bacteria and viruses. Studies have found that the type of bacteria in the human gut during infancy may affect the development of allergic diseases later in life by impacting the developing immune system. This study is testing whether the administration of specific bacteria may help prevent allergic diseases in newborns who are at risk for developing allergic diseases later in life.

  1. What would it mean to have a product able to prevent atopic diseases?

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 Siolta’s Adored Study is to test if STMC-103H, a consortium of commensal microbes, is able to 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. In light of 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.

  1. How can those who are interested become involved in the study, and what does the study involve?

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/#section-find or at clinicaltrials.gov.

Participants enrolled in the study will be randomized to receive treatment (STMC-103H) or placebo (no treatment) for a period of 11 months. There will be no cost for the participants, and Siolta will provide reimbursement for travel expenses so participants can visit the clinical trial sites when needed.

About STMC-103H

STMC-103H is a Live Biotherapeutic Product (LBP) being developed by Siolta Therapeutics for the prevention and treatment of atopic diseases (atopic dermatitis, atopic asthma, food allergy, allergic rhinitis) in at-risk newborns based on an immediate family history of atopic diseases.

STMC-103H contains a combination of bacterial species that are depleted in the gut microbiota of infants who go on to develop allergic sensitization and allergic diseases in childhood. In animal studies, STMC-103H’s immunomodulatory bacterial consortium functions synergistically to prevent allergic inflammation.

About Atopic Diseases

The atopic march refers to the tendency of atopic diseases to develop over infancy and childhood, beginning with atopic dermatitis and IgE-mediated food allergy to asthma and allergic rhinitis. An estimated 20 million children and adolescents live with atopic diseases in the US. Up to 30% of newborns are at-risk of developing atopic diseases. There are no approved products to prevent the development of these diseases in at-risk individuals, resulting in chronic morbidity, impaired quality-of-life, and a substantial economic burden.

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