| CTRI Number |
CTRI/2017/10/010018 [Registered on: 06/10/2017] Trial Registered Prospectively |
| Last Modified On: |
02/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Other (Specify) [Effect of Probiotics in the treatment of A topic dermatitis] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
PROBIOTICS IN TREATMENT OF ATOPIC DERMATITIS IN CHILDREN. |
|
Scientific Title of Study
|
EFFECT OF PROBIOTICS IN THE TREATMENT OF ATOPIC DERMATITIS IN CHILDREN - A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhayalini RK |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education and Research |
| Address |
Department Of Pediatrics, JIPMER Women and Children Hospital, JIPMER Hospital, Dhanvantri Hagar , Gorimedu
No.316, Old Blackwell House, JIPMER Campus,Dhanvantri Hagar,Gorimedu
Pondicherry
PONDICHERRY
605 006
India |
| Phone |
9042320571 |
| Fax |
|
| Email |
dhayaliniraj22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNiranjan Biswal |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education and Research |
| Address |
Department of Pediatrics, JIPMER Women and Children Hospital.
Pondicherry
PONDICHERRY
605 006
India |
| Phone |
9042320571 |
| Fax |
|
| Email |
drnbiswal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhayalini RK |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education and Research |
| Address |
Department of Pediatrics, JIPMER Women and Children Hospital
Pondicherry
PONDICHERRY
605 006
India |
| Phone |
9042320571 |
| Fax |
|
| Email |
dhayaliniraj22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Ethics Committee ( human studies )- intramural grant |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER,Dhanvanthri Hagar,Gorimedu, Pondicherry |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| not applicable |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dhayalini RK |
JIPMER Hospital |
Department of Pediatrics ( OPD 165) and Department of Dermatology(OPD 72), JIPMER Hospital,Dhanvanthri Nagar, Gorimedu, Pondicherry 605006
Pondicherry
PONDICHERRY |
9042320571
dhayaliniraj22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institutional Ethics Committee ( Human studies ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Atopic dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
PROBIOTICS |
All children meeting the inclusion criteria will be randomized and alloted into 2 groups. Lactobacillus rhamnosus GG 10 billion CFU per capsule/sachet will be provided everyday for a period of 3 months to the group A along with standard treatment and placebo(anhydrous glucose powder) will be given for 3 months along with standard treatment for 3 months. All children will be followed up for a period of 1 year. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All children from 6 months till 18 years attending JIPMER Pediatrics and Dermatology OPD. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in SCORAD Index - scoring criteria for a topic dermatitis |
Decrease in SCORAD index to be assessed every week following Probiotics supplementation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Change in skin microflora assessed by skin cultures
2) Change in IgE antibody titres measured by IgE ELISA kits
3) Change in absolute eosinophil counts
4) Alteration in gut microflora assessed by stool culture and demonstrate the presence of lactobacillus |
1 year |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
01/11/2017 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |