What if a baby is more prone to getting allergies because of poor gut immunity? The kind of bacteria in the human gut during infancy may affect the development of allergic disease later in life. Allergic diseases like atopic dermatitis (allergic eczema), food allergy, asthma and allergic rhinitis (hay fever) can significantly affect your child’s life. Currently, there are no approved treatments to prevent allergic diseases from happening. 

An infant allergy development prevention research study is being done across multiple research sites in the United States and Australia. This study involves testing an investigational product to strengthen gut immunity and in turn, prevent allergic disease development. Researchers aim to understand if this investigational product could prevent the onset of allergic disease among newborns with a family history of having an allergic disease.

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. If there were a way to prevent your child from getting allergies, would you take it? Read on to learn more.

• You and your child will be contributing valuable information that may benefit other children in the future.
• Your child may receive an investigational product that is the first of its kind at no cost.
• The investigational product may help prevent the development of allergic disease which may enhance your child’s wellbeing.
• Parents will be compensated for their time and reasonable travel expenses.
• You and your child will be helping to advance baby allergy prevention research.

• If you decide to participate in the study and later feel that you or your baby no longer wish to be part of it, you can withdraw at any time with no negative effect on your access to healthcare for your baby.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your baby’s health as it relates to the study.

• Pregnant mothers who are at least 18 years old or mothers who have just given birth within the last 7 days:
  • For mothers who have just given birth, their baby’s birth weight must be:
    • For Australia: > 2.5kg to <4.5 kg
    • For USA: > 5.5lbs to < 9.9lbs
  • For mothers who have given birth, their baby must have been born at or after 35 weeks of gestation
• The biological mother of the child, biological father of the child or biological sibling of the child (if applicable) must have a history of asthma, eczema, a food allergy or allergic rhinitis
• The primary caregiver of the child and the child must be able to commit to this research study for over approximately 2 years

The study team will explain the research study in its entirety but some details are:

• There will be some sites that will offer for select study visits to be completed at home (Home Healthcare visits).
• Siolta Therapeutics is sponsoring this research study. Siolta Therapeutics is 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 powder 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.

This research study is taking place in several locations. To see if there is a research site near you, please see below.

Research Site: Lurie Children’s Hospital
Location: 225 E Chicago Ave, Box 60, Chicago, IL 60611, United States
Lead Researcher: Melanie M. Makhija, MS, MD

Research Site: UT Southwestern Medical Center
Location: 5323 Harry Hines Blvd, Dallas, TX 75390, United States
Lead Researcher: Drew Bird, MD

Research Site: University of Arizona
Location: Tucson, AZ, 85724, United States
Lead Researcher: Heather Cassell, MD

Research Site: Tribe Clinical Research
Location: 545 Verdae Blvd Suite B, Greenville, SC 29607, United States
Lead Researcher: Scott Dobson

Research Site: Johns Hopkins University School of Medicine
Location: Baltimore, MD 21287, United States
Lead Researcher: Dr. Robert A. Wood

Research Site: Rady Children’s Hospital – San Diego, Food Allergy Center UCSD Pediatrics
Location: 3030 Children’s Way 2nd Floor North, San Diego, CA 92123
Lead Researcher: Stephanie Leonard, MD

Research Site: Children’s Hospital Colorado
Location: 13123 E 16th Ave, Aurora, CO 80045, United States
Lead Researcher: Matthew Greenhawt, MD

Research Site: NYU Langone Health
Location: 160 East 32nd Street, New York NY 10016
Lead Researcher: Anna Nowak-Wegrzyn, MD, PhD

This study has been reviewed and approved by the relevant Institutional Review Board and/or Ethics Committee for each site.