Comparison of therapeutic effect of Probiotoc ointment in the treatment of Atopic Dermatitis in children.
Design
This is a randomised, double _ blind, parallel _ group, controlled phase 3 study.In this study, 60 childs with Atopic Dermatitis will be randomly divided in to two groups of 30 in each, using Rand List software.The control group will recieve Placebo ointment and intervention group will recieve Probiotic ointment.
Settings and conduct
sixty childs with Atopic Dermatitis who will refer to Akbar allergy clinic will randomly be assigned in to two groups of 30 subjects Intervention group (probiotic ointment) and 30 subjects the control group (placebo ointment).
Participants/Inclusion and exclusion criteria
Inclusion criteria: children 6 mounth-5 years old, children with moderate to severe disease, children whose parents declare their full written informed consent to participate in this study.Exclusion criteria: children who have other skin conditions at the same time, children whose skin lesions are infected.
Intervention groups
Intervention group: probiotic ointment.in the intervention group, 30 childs with Atopic Dermatitis will be treated with probiotic ointment every 12 hours for 4 weeks.Control group: topical placebo ointment.in the control group 30 childs with Atopic Dermatitis will be treated with placebo ointment every 12 hours for 4 weeks.
Main outcome variables
Atopic Dermatitis lesions severity index, size of Atopic Dermatitis, patients symptoms, possible complications.
General information
Reason for update
Acronym
AD:Atopic Dermatitis
IRCT registration information
IRCT registration number:IRCT20200117046164N1
Registration date:2020-04-18, 1399/01/30
Registration timing:prospective
Last update:2020-04-18, 1399/01/30
Update count:0
Registration date
2020-04-18, 1399/01/30
Registrant information
Name
Nasrin Moazzen
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 0000
Email address
moazzenn@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-09-19, 1399/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Probiotic cream containing bacteria killed in children with Atopic Dermatitis.
Public title
Effect of the Probioti in treatment of Atopic Dermatitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with moderate to severe Disease.
Exclusion criteria:
Children who have other skin conditions at the same time.
Children whose parents declare their full written informed consent to participate in this study.
Age
From 6 months old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization will be carried out on an individual basis by Rand List software.The allocation will be seated by an independent monitor and will not be broken until the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The investigator assessing outcome and analyzing the data will be blinded to treatment allocation until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad University of Medical Sciences
Street address
Akbar Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195933516
Approval date
2019-07-23, 1398/05/01
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.796
Health conditions studied
1
Description of health condition studied
Atopic Dermatitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Atopic Dermatitis severity index
Timepoint
Weeks 0, 2, 4
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Topical Placebu ointment.in the intervention group,30 childs with Atopic Dermatitis will be treated with Placebu ointment every 12 hours for 4 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Obtaining topical ointment containing probiotics. In the intervention group, 30 children with atopic dermatitis will receive probiotic ointment lactobacillus palntarum every 12 hours for 4 weeks. In order to prepare probiotic cream from microbial bacterial culture, microbial suspension with 108 CFU / mL concentration It is prepared and incubated in MRS culture medium for 48 hours at 37. C. This product under the AllVia® brand contains 5% by weight of probiotics in cream base. To prepare the cream, after bacterial inactivation, the bacterial precipitate is weighed and mixed with a certain amount of the cream and mixed until a cream containing 5% probiotic is finally obtained.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Hospital
Full name of responsible person
Dr nasrin moazzen
Street address
Akbar Hospital Kaveh street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195933516
Phone
+98 51 3713 3101
Email
dr.masrour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nasrin Moazzen
Street address
Vakilabad Boulevard, facing Mellat Park,Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9195933516
Phone
+98 51 3713 3101
Email
dr.masrour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Nasrin Moazzen
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Fakouri Blvd, Akbar children Hospital, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195933516
Phone
+98 51 3713 3101
Email
moazzenn@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nasrin Moazzen
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Fakouri Blvd, Akbar children Hospital, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195933516
Phone
+98 51 3713 3101
Email
moazzenn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Hossein Masrour Naeimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Fakouri Blvd, Akbar children Hospital, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195933516
Phone
+98 58 3713 3101
Email
Dr.masrour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shared after being unidentified.
When the data will become available and for how long
All any time
To whom data/document is available
It will be free for every one.
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Email: moazzenn@mums.ac.ir, 09151034644, Dr Nasrin Moazzen, Akbar Hospital - Kaveh sreet - Mashhad.
What processes are involved for a request to access data/document
The request will be checked, then data will be sent by Email in 1 month.