US 12,138,286 B2
Combination method for treating or preventing childhood atopic disease
Richard A. Insel, Skillman, NJ (US); Linda Alunkal, Wayne, PA (US); and Russell Gould, Skillman, NJ (US)
Assigned to Johnson & Johnson Consumer Inc., Skillman, NJ (US)
Filed by Johnson & Johnson Consumer Inc., Skillman, NJ (US)
Filed on Nov. 27, 2023, as Appl. No. 18/519,981.
Application 18/519,981 is a continuation of application No. PCT/IB2023/055593, filed on May 31, 2023.
Claims priority of provisional application 63/347,206, filed on May 31, 2022.
Prior Publication US 2024/0165172 A1, May 23, 2024
Int. Cl. A61K 35/745 (2015.01); A61K 9/00 (2006.01); A61K 31/164 (2006.01); A61K 35/00 (2006.01); A61P 17/00 (2006.01)
CPC A61K 35/745 (2013.01) [A61K 9/0014 (2013.01); A61K 9/0053 (2013.01); A61K 31/164 (2013.01); A61P 17/00 (2018.01); A61K 2035/115 (2013.01)] 20 Claims
 
1. A method of immune system regulation in an infant, comprising:
identifying an infant at high risk for atopic dermatitis based on at least a parental history of atopic disease;
administering to the infant a composition comprising about 5 billion to about 15 billion colony-forming units (CFU) of Bifidobacterium infantis (B. infantis) once daily for at least 12 weeks, wherein the administration starts within about 30 days of birth;
treating the skin of the infant with an effective amount of an emollient, comprising:
about 0.005% to about 0.1% ceramide 3, and
saturated fatty acids,
wherein the ceramide and saturated fatty acids creates a water-impermeable, protective layer to prevent excessive water loss due to evaporation and provide a barrier against the entry of microorganisms,
at least once a day for at least 8 weeks, wherein the treating begins within about 4 days of birth; and
orally administering to the infant a premeasured dose of one to six allergenic foods within about 1-8 months after the birth of the infant;
wherein the method provides a statistically significant reduction in atopic dermatitis at 12 months or at 52 weeks compared to an untreated group in a clinical setting.