A study to observe if probiotics supplementation is helpful in atopic dermatitis children
Phase 3
Recruiting
- Conditions
- Patients of atopic dermatitis but who have chronic illness and are immunosuppressive are not recruited in the study.
- Registration Number
- CTRI/2017/08/009236
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Recruitment of the patients have already been started for the study with proper written consent and it is under process.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
- Children with atopic dermatitis diagnosed according to Hanifin and Rajka between aged 6 months to 12 years.
- All children in the above mentioned age group with be eligible irrespective of the disease severity.
Exclusion Criteria
- Immunocompromised chilren 2.
- Children with severe hepatic, renal or other systemic disease 3.
- <6 months and >12 years of age.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The mean difference in SCORAD in children with AD treated with conventional treatment plus probiotic supplementation versus conventional treatment alone at 0,12 and 24 weeks. 0,12 and 24 weeks 2. Mean difference in the number of days of treatment required to achieve 90% reduction in SCORAD in children with AD treated with conventional treatment plus probiotic supplementation versus conventional treatment alone. 0,12 and 24 weeks 3. Number of children with AD who relapse after stoppage of treatment at 24 weeks 0,12 and 24 weeks
- Secondary Outcome Measures
Name Time Method 1. To compare the IL-17 level in treatment vs control group at baseline and at 12 weeks 2. To compare the CDLQI and IDQOL at baseline and at 12 and 24 weeks
Trial Locations
- Locations (1)
PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
PGIMER🇮🇳Chandigarh, CHANDIGARH, IndiaRicha SharmaPrincipal investigator8284808032reechasharma99@gmail.com