A Phase 1b/2 randomized double-blind placebo-controlled multi-center study of STMC-103H in neonates and infants at high-risk for developing allergic disease | NYU Langone Health

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Type I Allergic Diseases (atopic Dermatitis, Food Allergy, Allergic Asthma And Allergic Rhinitis/conjunctivitis)
Age: Between 7 years - 12 years
Gender: Male or Female

Other Inclusion Criteria:
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 Only: Subject is =7 days of life at the time of enrollment.
6. Part B Only: Subject has a birthweight =2.5 kg and =4.5 kg
7. Part B Only: 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.

You may not be eligible for this study if the following are true:

1. Subject's twin (or higher order multiple) is enrolled in STMC-103H-102
2. Subject has any congenital abnormalities or condition, significant disease, illness, physical exam finding, or disorder that, in the opinion of the PI, may put the subject at safety risk or is likely to hinder feeding or affect metabolism that may influence the results of the study
3. Subject is acutely ill or on systemic antibiotics at the time of enrollment
4. Subject is participating in another interventional clinical study involving investigational medication, formula, probiotic, or prebiotic use within 30 days (or five half-lives, whichever is longer) of this study
5. Subject has evidence of immune deficiency/immune compromise in the judgment of the investigator
6. Part B Only: Subject was born at < 35 weeks' gestation
7. Part B Only: Biological maternal medical condition during the pregnancy that, in the opinion of the PI, may put the subject at risk because of participation in the study