A Phase 1b/2, randomized, double-blind, placebo-controlled, multicenter study of STMC-103H in neonates and infants at risk for developing allergic disease

Study Description

This is a Phase 1b/2, randomized, double-blind, placebo-controlled, 3-part, multi-center study of STMC-103H in neonates and infants at risk for developing allergic disease (type I hypersensitivity). Subjects will be enrolled in a 3-part sequential approach (Parts A1, A2, and B)

Study Eligibility

1. Subject’s parent(s)/legal representative(s) providing consent must be 18 years or older
2. Biological mother and/or biological father and/or full sibling(s), have a history of asthma, atopic dermatitis, food allergy, or allergic rhinitis as determined by the screening questionnaire
3. Subject’s parent(s)/legal representative(s) (if appropriate according to local laws) is/are willing and able to give informed consent for participation in the study
4. Subject’s parent(s)/legal representative(s) (if appropriate according to local laws) is/are willing and able, in the PI’s opinion, to comply with all study requirements
5. (Part B). Subject is ≤14 days of life at the time of enrollment. Sites should make every effort to enroll newborns as soon as possible after birth.
6. (Part B). Subject has a birthweight ≥2.5 kg and ≤4.5 kg
7. (Part B). Subject’s parent(s)/legal representative(s) do not plan to give probiotics (including infant formula that contain probiotics) to the subject from the time of birth to the end of the trial.

Contact Information

Phone: 501-364-3886
Email: whitesided@archildrens.org