KCT0000914.

Trial name or title	IRT5 probiotics atopic dermatitis
Methods	Phase III 8‐week parallel‐group randomised double‐blind placebo‐controlled clinical trial
Participants	Children 5 to 12 years of age with atopic dermatitis, SCORAD score between 25 and 50, and continuous or intermittent symptoms of atopic dermatitis over 6 months. Target sample size = 110 participants; 55 in each group Other inclusion criterion: signs informed consent form with a legal representative before participating in the study Exclusion criteria Other systemic illnesses or dermatitis history except AD Receiving immunosuppressants, antibiotics, corticosteroids, antihistamines within 4 weeks Has taken medicines, Chinese medicine, health functional foods within 4 weeks for improvement of atopic dermatitis Systemic phototherapy within 1 month Probiotics within 2 weeks Scheduled to participate in another study during this study period or participated in other study within 4 weeks Inappropriate for participation as decided by investigator
Interventions	Probiotic: IRT5 probiotics, 1 × 10¹º CFUs/sachet, to be taken orally 1 sachet per day for 8 weeks Placebo group: lactose, to be taken orally 1 sachet per day for 8 weeks
Outcomes	Primary SCORAD score at baseline and at 6 and 12 weeks Secondary Immunoglobulin A Skin condition measurement (moisture, skin oil, skin‐ph‐meter) at baseline and at 6 and 12 weeks Eosinophil, total IgE, eosinophil cationic protein at baseline and at 12 weeks
Starting date	Date of first enrolment: 06/11/2013
Contact information	Professor Kim Beom Jun, CHUNG‐ANG University, Korea
Notes	Registration: KCT0000914. Current status: recruiting. No updates to the registry since 2013 Primary sponsor: KOREA YAKULT CORPORATION. Affiliation: CHUNG‐ANG University