| CTRI Number |
CTRI/2022/01/039781 [Registered on: 28/01/2022] Trial Registered Prospectively |
| Last Modified On: |
09/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To Evaluate the Safety and Efficacy of Oral administration of Tep-AD® (probiotic Lactobacillus salivarius) in Indian Children having by Moderate and Severe Atopic Dermatitis. |
|
Scientific Title of Study
|
Open label, Multicentric, Comparative, Randomized
Clinical Study to Evaluate the Safety and Efficacy of
Oral administration of Tep-AD® (probiotic
Lactobacillus salivarius) in Indian Children having by
Moderate and Severe 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 |
Dr Rashmi Mahajan |
| Designation |
Principal Investigator |
| Affiliation |
GnR Skin and Heart Clinic |
| Address |
22/142, Vikram Vihar, Lajpat Nagar 4, Near gate 15, New Delhi
New Delhi
DELHI
110024
India |
| Phone |
|
| Fax |
|
| Email |
rashmigaurav2901@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Pvt. Ltd |
| Address |
2/5, Dahila Building, 3rd Floor
80 Feet Road, RMV 2nd Stage, Dollars Colony
Bangalore
KARNATAKA
560094
India |
| Phone |
09538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Pvt. Ltd |
| Address |
2/5, Dahila Building, 3rd Floor
80 Feet Road, RMV 2nd Stage, Dollars Colony
Bangalore
KARNATAKA
560094
India |
| Phone |
09538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Inzpera Healthsciences Limited Nirmal Galaxy, 215-217, Avior Corporate Park, Lal Bahadur Shastri Rd, Mulund West, Mumbai, Maharashtra 400080 |
|
|
Primary Sponsor
|
| Name |
Inzpera Healthsciences Limited |
| Address |
Nirmal Galaxy, 215-217, Avior Corporate Park, Lal Bahadur Shastri Rd, Mulund West, Mumbai, Maharashtra 400080 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samipa Samir Mukherjee |
Cloudnine Hospitals |
Cloudnine Hospital, 115, HAL Old Airport Rd, Nanja Reddy Colony, Jeevan Bima Nagar, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA |
9972899728
drsamipadermatology@gmail.com |
| Dr Rashmi Mahajan |
GnR Skin and Heart Clinic |
GnR Skin and Heart Clinic, 22/142, Vikram Vihar, Lajpat Nagar 4, Near gate 15, New Delhi-110024
New Delhi
DELHI |
9540071071
rashmigaurav2901@gmail.com |
| Dr Vijay Warad |
Sai Allergy asthma Eye Children Hospital |
Sai Allergy asthma Eye Children Hospital
102,A2, wing 1st Flr, Aranyeshwar Park Phase 2,
Aranyeshwar, Taljai Rd, Parvati Paytha,
Pune, Maharashtra 411009
Pune
MAHARASHTRA |
7719800464
drvijaypwarad@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Good Social Ethical Research |
Approved |
| Institutional Ethics Committee, Cloudnine Hospital, Bangalore |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Male or female children between 0-11 years of age (both inclusive)
Suffering from moderate or severe atopic dermatitis.
Children and parents / guardians who agree to comply with study requirement and schedule.
Parents or legal guardians willing to sign written informed consent form for the child and child
willing to sign assent form for participation (if old enough to understand his /her participation
in study) |
|
| ExclusionCriteria |
| Details |
1. Use of analgesics within <12 hours prior to the study start or/and inability to cancel them during
the study.
2. Use of antibiotics within <48 hours prior to the study start or/and inability to cancel them during
the study.
3. Subjects with any other chronic illness such as acute asthma, heart blocks, any congenital
anomaly.
4. Subjects with chronic and infectious diseases.
5. Subjects with hypersensitivity to any components contained in the probiotic sachets.
6. Inability to keep return appointments.
7. Participated in any clinical investigation in the last 30 days.
8. Not found suitable as per discretion of investigator |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Tep-AD® (probiotic formulation containing Lactobacillus salivarius-2×10â¹
CFU/sachet) when administered orally for the treatment of moderate and severe atopic dermatitis (AD)
in children using:
i. Objective SCORAD / SCORAD index
ii. Itch index |
Timepoints will be assessed in all visits. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient reported outcomes of worsening of any baseline symptoms evaluated at every visit until
post treatment follow-up visit.
Changes in the vital parameters; body temperature, pulse rate, respiratory rate from baseline to
the end of treatment.
Physicians Global Assessment at the end of the study using 4-point scale.
The steroid sparing measure due to Tep-AD® in the investigational Arm. |
Timepoints will be assessed in all visits. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/02/2022 |
| 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="0"
Months="6"
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
|
Atopic dermatitis (AD) is a chronic inflammatory skin disease with multifactorial etiopathology, which is most prevalent in childhood. Normally, childhood AD appears in the first 5 years of life, with about 60% of cases appearing between 0 and 6 months. The decreased microbial exposure due to urbanization, the intensive use of antibiotics and vaccines, and improved infant sanitation lead to the increased development of AD. |