Allergic Disease Onset Prevention Study (adored)
Atopic Dermatitis, Type 1 Hypersensitivity
About this trial
This is an interventional prevention trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
All Parts (A1, A2, B)
- Subject's parent(s)/legal representative(s) providing consent must be 18 years or older
- 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
- 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
- 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
Part A1 Only
Inclusion criteria 1-4 for all parts plus:
5 (A1). Subject is between 1 year and < 6 years old at the time of enrollment
Part A2 Only
Inclusion criteria 1-4 for all parts plus:
5 (A2). Subject is between 28 days and < 12 months of life at the time of enrollment 6 (A2). Subject's parent(s)/legal representative(s) do not plan to give probiotics (including infant formula that contain probiotics) to the subject during the trial
Part B Only
Inclusion criteria 1-4 for all parts plus:
5 (B). Subject is ≤ 7 days of life at the time of enrollment. Sites should make every effort to enroll newborns as soon as possible after birth.
6 (B). Subject has a birthweight ≥ 2.5 kg and ≤ 4.5 kg 7 (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.
Exclusion Criteria:
All Parts (A1, A2, B)
- Subject's twin (or higher order multiple) is enrolled in STMC-103H-102
- 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. (Neonatal hyperbilirubinemia (jaundice), including jaundice that requires phototherapy, should not be considered exclusionary).
- Subject is acutely ill or on systemic antibiotics at the time of enrollment
- 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
- Subject has evidence of immune deficiency/immune compromise in the judgment of the investigator
Part B Only
Exclusion Criteria 1-5 for all parts plus:
6 (B). Subject was born at < 35 weeks' gestation 7 (B). 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. (Maternal antibiotics during the time of delivery should not be considered exclusionary.)
Sites / Locations
- University of Arizona Health SciencesRecruiting
- Arkansas Children's Research InstituteRecruiting
- UCLA HealthRecruiting
- Rady Children's Hospital - San DiegoRecruiting
- UCSF Benioff Children's HospitalRecruiting
- Children's Hospital ColoradoRecruiting
- Children's Healthcare of AtlantaRecruiting
- Lurie Children's HospitalRecruiting
- University of Chicago MedicineRecruiting
- Riley Children's Health at University of IndianaRecruiting
- Johns Hopkins University School of MedicineRecruiting
- Boston Children's HospitalRecruiting
- University of Michigan HealthRecruiting
- Northwell HealthcareRecruiting
- NYU Langone Fink Children'sRecruiting
- Mt. Sinai Jaffe Allergy InstituteRecruiting
- University of Rochester Medical CenterRecruiting
- Cincinnati Children's HospitalRecruiting
- Tribe Clinical ResearchRecruiting
- Coastal Pediatrics ResearchRecruiting
- Dell Medical School at UT AustinRecruiting
- UT Southwestern/Children's HealthRecruiting
- Seattle Allergy and Asthma Research InstituteRecruiting
- Univ. of Wisconsin-Madison/Jackson Research GroupRecruiting
- The Children's Hospital at WestmeadRecruiting
- Queensland Children's HospitalRecruiting
- The Women's and Children's HospitalRecruiting
- Monash Children's HospitalRecruiting
- Murdoch Children's Research InstituteRecruiting
- Fiona Stanley HospitalRecruiting
- Centro de Neumologia PediatricaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
STMC-103H Part A1
Placebo Part A1
STMC-102H Part A2
Placebo Part A2
STMC-103H Part B
Placebo Part B
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days
Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days
Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days