Probiotics in Eczema

Recruiting

Conditions: Atopic dermatitis, unspecified,

Registration Number: CTRI/2022/07/044171

Lead Sponsor: RESEARCH CELL ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR

Brief Summary: This study will be conducted in atopicdermatitis patients, attending Dermatology, Venereology and Leprology OPD atAIIMS JODHPUR through telemedicine or Physical OPD consultation.

Diagnosisbased on U.K. working party diagnostic criteria and patients fulfilling theselection criteria, will be recruited in the study after informed writtenconsent. Detailed history and clinicalexamination of the selected patients will be done.Random allocation and allocation concealment will be done using Lottery method.Single blinding will be done and randomization sequence will be transferredin an opaque sealed envelope

For both thegroup SCORAD scoring will be done, Level of IL-31 will be measured to be takenas baseline value.

Group A will be treated with topicalcorticosteroid and emollient twice daily as per standard treatment protocol.

Topicalcorticosteroid will be given for maximum of 4 weeks in both the groups.

In Group A Probiotic rhamosus GG will becontinued for 8 more weeks. Total 12 weeks Probiotics Lactobacillus rhamnosusGG will be given in Group A.

Group B willbe given topical corticosteroid (acc. to standard topical treatment protocol)-

1.Mild: SCORAD<25 / or transient eczema -topical mid potency steroid + emollientapplication twice daily

2. Moderate: SCORAD25-50 / or recurrent eczema-topical mid potency steroid + emollientapplication twice daily

Follow up:Every 2 weeks for the first month and then monthly follow up will be done fortreatment response, number of episodes of flare up, need for topical corticosteroid therapy forflare up and side effects related to therapy.

SCORADcalculation will be done at 0 and 12 weeks.

Level of IL-31will be done at 0 and 12 weeks.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 64

Inclusion Criteria

Clinically diagnosed cases of atopic dermatitis (U.K. Working Party diagnostic criteria) Patient with SCORAD of <50 Patients whose parents or legal representative signed the written informed consent Treatment wash off period of atleast 2 months for systemic corticosteroids and immunosuppressants.

Exclusion Criteria

Patient with chronic underlying disease (uncontrolled diabetes mellitus, uncontrolled hypertension, active tuberculosis) or is on immunosuppressive therapy.
Children with severe hepatic, renal or other systemic disease.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in SCORAD	1. Change in SCORAD at 0 and 12 week

Secondary Outcome Measures

Name	Time	Method
1. IL-31 level value change	2. Number of replapses

Trial Locations

Locations (1): AIIMS, JODHPUR
🇮🇳
Jodhpur, RAJASTHAN, India
AIIMS, JODHPUR
🇮🇳Jodhpur, RAJASTHAN, India
DR ANIL BUDANIA
Principal investigator
9213361424
anilbuddy25@gmail.com