CTRI/2017/08/009236.

Trial name or title	A study to observe if probiotics supplementation is helpful in atopic dermatitis in children
Methods	Phase III randomised placebo‐controlled parallel‐group trial. Blinded investigator. Randomisation computer generated
Participants	Children of both genders, from 6 months to 12 years of age who have atopic dermatitis of any severity diagnosed based on the Hanifin and Rajka criteria Exclusion criteria: immunocompromised children; children with severe kidney, liver, or systemic disease; other ages Target sample size = 114
Interventions	Probiotics and placebo. No other information available
Outcomes	Primary outcomes Mean difference in SCORAD among children with atopic dermatitis treated with conventional treatment plus probiotic supplementation vs conventional treatment alone at 0, 12, and 24 weeks Mean difference in the numbers of days of treatment required to achieve 90% reduction in SCORAD among children with atopic dermatitis treated with conventional treatment plus probiotic supplementation vs conventional treatment alone Number of children with atopic dermatitis who relapse after stoppage of treatment at 24 weeks Secondary outcomes Comparison of IL‐17 level in treatment vs control at 0 and 12 weeks Comparisong of CDLQI and IDLQI at baseline and at 12 and 24 weeks
Starting date	Date of first enrolment: 02/07/2016
Contact information	Professor Sanjeev Handa, Professor of Dermatology, Venereology, and Leprology handa_sanjeev@yahoo.com Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India
Notes	Study sponsored by PGIMER Currently recruiting