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ADORED-Allergic Disease Onset Prevention Study

Research Question:
The primary objective of Parts A1 and A2 of this study is to assess the safety and tolerability of STMC-103H in children and infant subjects at risk for development of allergic disease.

Basic Study Information

Purpose:
Early administration of beneficial bacteria that promote immune tolerance represents a novel approach for the prevention and treatment of allergic diseases, such as atopic dermatitis and asthma. STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria that may impact the incidence of allergic sensitization and disease in neonates and infants at risk for developing allergy and asthma. STMC-103H is an oral capsule containing powder which will be mixed with a small amount of breastmilk, the participant’s formula, or a milk product. Siolta Therapeutics is testing this investigational drug for the prevention of allergic diseases, including atopic dermatitis (eczema), food allergy, asthma, and allergic rhinitis (hay fever).

Location: UR Medicine
Study Web URL: https://www.urmc.rochester.edu/childrens-hospital/allergy.aspx
Study Reference #: STUDY00006587

Lead Researcher (Principal Investigator)

Lead Researcher: Kirsi Jarvinen-seppo

Study Contact Information

Study Coordinator: Allison Leadley
Phone: (585) 275-4640
Email: allergy_research@urmc.rochester.edu

Additional Study Details

Study Details:
Early administration of beneficial bacteria that promote immune tolerance represents a novel approach for the prevention and treatment of allergic diseases, such as atopic dermatitis and asthma. STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria that may impact the incidence of allergic sensitization and disease in neonates and infants at risk for developing allergy and asthma. STMC-103H is an oral capsule containing powder which will be mixed with a small amount of breastmilk, the participant’s formula, or a milk product. Siolta Therapeutics is testing this investigational drug for the prevention of allergic diseases, including atopic dermatitis (eczema), food allergy, asthma, and allergic rhinitis (hay fever).

Number of Visits: 6 to 10
Parking: Reimbursed
Reimbursement: Yes