| CTRI Number |
CTRI/2022/07/044171 [Registered on: 20/07/2022] Trial Registered Prospectively |
| Last Modified On: |
03/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Probiotics in Eczema |
|
Scientific Title of Study
|
Efficacy of probiotics combined with standard topical therapy compared to standard topical therapy in atopic dermatitis : a randomised study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Budania |
| Designation |
Associate professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
| Address |
ROOM NO 313,THIRD FLOOR, COLLEGE BUILDING, AIIMS, BASNI INDUSTRIAL AREA
PHASE-2, JODHPUR. RAJASTHAN 342005 India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9213361424 |
| Fax |
|
| Email |
anilbuddy25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Budania |
| Designation |
Associate professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
| Address |
ROOM NO 313,THIRD FLOOR, COLLEGE BUILDING, AIIMS, BASNI INDUSTRIAL AREA
PHASE-2, JODHPUR. RAJASTHAN 342005 India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9213361424 |
| Fax |
|
| Email |
anilbuddy25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nazneen Bano |
| Designation |
Post graduate student |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
| Address |
ROOM NO 111, DEPARTMENT OF DERMATOLOGY, AIIMS, AIIMS
OPD BLOCK A, FIRST FLOOR, AIIMS HOSPITAL, BASNI
INDUSTRIAL AREA PHASE-2, JODHPUR. RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7742270159 |
| Fax |
|
| Email |
naz15bano6@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
|
|
Primary Sponsor
|
| Name |
RESEARCH CELL ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BASNI
INDUSTRIAL AREA PHASE-2. JODHPUR, 342005 |
| 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 |
| DR ANIL BUDANIA |
AIIMS, JODHPUR |
DEPARTMENT OF
DERMATOLOGY, ALL
INDIA INSTITUTE OF
MEDICAL SCIENCES,
AIIMS OPD BLOCK A,
FIRST FLOOR, AIIMS
HOSPITAL, BASNI
INDUSTRIAL AREA
PHASE-2, JODHPUR.
Jodhpur
RAJASTHAN |
9213361424
anilbuddy25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Probiotics (Lactobacillus rhamnosus GG) with topical corticosteroid and emollient |
Tablet/sachet form, oral probiotic (Lactobacillus rhamnosus GG) 6 billion CFU twice daily for 3 months, topical corticosteroid (mid potency) and emollient application twice daily |
| Comparator Agent |
Topical corticosteroid and emollient |
Mid potency corticosteroid plus emollient application twice daily |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in SCORAD
|
1. Change in SCORAD at 0 and 12 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. IL-31 level value change
2. Number of replapses
3. Adverse event if any |
1. IL-31 at 0 and 12 week
2. Relapses - Need for topical corticosteroid therapy with duration in follow up
3. Adverse event at each visit
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2022 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted in atopic
dermatitis patients, attending Dermatology, Venereology and Leprology OPD at
AIIMS JODHPUR through telemedicine or Physical OPD consultation. Diagnosis
based on U.K. working party diagnostic criteria and patients fulfilling the
selection criteria, will be recruited in the study after informed written
consent. Detailed history and clinical
examination 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 transferred
in an opaque sealed envelope For both the
group SCORAD scoring will be done, Level of IL-31 will be measured to be taken
as baseline value.
Group A will be treated with topical
corticosteroid and emollient twice daily as per standard treatment protocol.
Topical
corticosteroid will be given for maximum of 4 weeks in both the groups.
In Group A Probiotic rhamosus GG will be
continued for 8 more weeks. Total 12 weeks Probiotics Lactobacillus rhamnosus
GG will be given in Group A.
Group B will
be given topical corticosteroid (acc. to standard topical treatment protocol)-
1. Mild: SCORAD
<25 / or transient eczema -topical mid potency steroid + emollient
application twice daily
2.
Moderate: SCORAD
25-50 / or recurrent eczema-topical mid potency steroid + emollient
application twice daily
Follow up:
Every 2 weeks for the first month and then monthly follow up will be done for
treatment response, number of episodes of flare up, need for topical corticosteroid therapy for
flare up and side effects related to therapy.
SCORAD
calculation will be done at 0 and 12 weeks.
Level of IL-31
will be done at 0 and 12 weeks. |