| CTRI Number |
CTRI/2017/08/009236 [Registered on: 02/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to observe if
probiotics supplementation is helpful in atopic dermatitis children |
|
Scientific Title of Study
|
A randomised controlled study to evaluate the effectiveness of probiotics supplementation in the treatment of atopic dermatitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa Sharma |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute Of Medical Education And Research (PGIMER) |
| Address |
PGIMER, Chandigarh, India
PGIMER, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8284808032 |
| Fax |
|
| Email |
reechasharma99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sanjeev Handa |
| Designation |
Professor and Head of Department of Dermatology, Venereology and leprology |
| Affiliation |
Post Graduate Institute Of Medical Education And Research (PGIMER) |
| Address |
PGIMER, Chandigarh, India
PGIMER, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815924777 |
| Fax |
|
| Email |
handa_sanjeev@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Richa Sharma |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute Of Medical Education And Research (PGIMER) |
| Address |
PGIMER, Chandigarh, India
PGIMER, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8284808032 |
| Fax |
|
| Email |
reechasharma99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
PGIMER, Chandigarh, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Richa Sharma |
PGIMER |
OPD, Department of Dermatology, venereology and leprology, pediatric clinic, 5th floor, Room no 5007
Chandigarh
CHANDIGARH |
8284808032
reechasharma99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients of atopic dermatitis but who have chronic illness and are immunosuppressive are not recruited in the study., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
This study aims to compare the efficacy of probiotics in atopic dermatitis(AD)children where they are divided into two groups. Group A will be receiving treatment for AD with supplementation of probiotics whereas Group B will be receiving only treatment for AD. No any placebo is used in this study for comparison. |
| Intervention |
Probiotics supplementation |
It is a randomised controlled trial with supplementation of the probiotics to one group of atopic dermatitis patients. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with atopic dermatitis diagnosed according to Hanifin and Rajka between aged 6 months to 12 years.
2. All children in the above mentioned age group with be eligible irrespective of the disease severity. |
|
| ExclusionCriteria |
| Details |
1. Immunocompromised chilren
2. Children with severe hepatic, renal or other systemic disease
3. <6 months and >12 years of age
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
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.
3. Number of children with AD who relapse after stoppage of treatment at 24 weeks |
0,12 and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 |
12, 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/07/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Study is under process with recruitment of patient under process. Analysis to be done then to be applied for publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Recruitment of the patients have already been started for the study with proper written consent and it is under process. |