CTRI/2017/10/010018.

Trial name or title	Probiotics in treatment of atopic dermatitis in children
Methods	Double‐blind randomised placebo‐controlled parallel‐group trial. Computer‐generated randomisation Method of allocation concealment: sequentially numbered, sealed, opaque envelopes
Participants	Children with atopic dermatitis of both genders, from 6 months to 18 years of age, attending JIPMER Paediatrics or Dermatology. Target sample size = 108 Exclusion criteria: children with acute gastrointestinal infection; children with chronic underlying disease on immunosuppressive therapy; children with known or suspected immunodeficiency; children on prolonged antibiotic and antituberculous therapy; children who are included in other studies
Interventions	Probiotic: Lactobacillus rhamnosus GG. Dose: 10 billion CFUs/capsule or sachet/d for 3 months Control: placebo: anhydrous glucose powder Both groups receive also standard treatment
Outcomes	Primary outcome Decrease in SCORAD index (weekly assessment after start of treatment) Secondary outcomes Changes in skin microflora assessed by skin cultures Changes in IgE antibody titres measured by IgE ELISA kits Change in absolute eosinophil counts Alteration in gut microflora assessed by stool cultures and demonstrated presence of Lactobacillus Time point for secondary outcomes: 1 year
Starting date	01/11/2017. Registered as not recruiting yet
Contact information	Dhayalini RK; dhayaliniraj22@gmail.com Department of Pediatrics (OPD 165) and Department of Dermatology (OPD 72), JIPMER Hospital, Dhauranthri Nagar, Gorimedu, Pondicherry 605006, PONDICHERRY
Notes	Country: India Registered prospectively Ethics approval received Sponsorship: JIPMER Hospital and Research Institution