PROBIOTICS IN TREATMENT OF ATOPIC DERMATITIS IN CHILDREN.

Not yet recruiting

• Conditions: Atopic dermatitis

• Registration Number: CTRI/2017/10/010018
• Lead Sponsor: JIPMER

Brief Summary

The purpose of this trial is to study the effect of Probiotics in the treatment of a topic dermatitis in children. The primary objective is to assess decrease in SCORAD Index which denotes the clinical severity of the disease. This trial also studies the changes in skin and gut microflora, absolute eosinophil counts, IgE antibody titres and trans epidermal water loss. All children from 6 months to 18 years attending JIPMER Pediatrics and Dermatology OPD who are meeting the inclusion criteria will be alloted to two groups A and B. Group A will receive Probiotics - lactobacillus rhamnosus GG 10 billion CFU per packet/sachet daily for a period of 3 months and group B will receive the placebo for 3 months along with the standard treatment. Skin and blood samples will be collected before and after Probiotics supplementation. Stool samples to demonstrate the gut microflora will be collected from one fourth of study population at the end of 3 months. Transepidermal water loss will be measured using a non invasive probe.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-11
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

All children from 6 months till 18 years attending JIPMER Pediatrics and Dermatology OPD.

Exclusion Criteria

• 1. Children with acute gastrointestinal infections.
• 2. Children with chronic underlying disease on immunosuppressive therapy.
• 3. Children with known or suspected immunodeficiency.
• 4. Children on prolonged antibiotic therapy and antituberculuos therapy.
• 5. Children who are a part of other studies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in SCORAD Index - scoring criteria for a topic dermatitis	Decrease in SCORAD index to be assessed every week following Probiotics supplementation

Secondary Outcome Measures

Name	Time	Method
1) Change in skin microflora assessed by skin cultures	2) Change in IgE antibody titres measured by IgE ELISA kits

Trial Locations

Locations (1)

JIPMER Hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

JIPMER Hospital

🇮🇳Pondicherry, PONDICHERRY, India

Dhayalini RK

Principal investigator

9042320571

dhayaliniraj22@gmail.com