Determining of the effect of a probiotic lotion containing lactobacillus reuteri strain JCM 1112 on controlling the clinical symptoms of atopic dermatitis
Design
Clinical trial with control and parallel groups, double blind and randomized
Settings and conduct
This is performed on 30 patients with atopic eczema referring to the allergy clinic of Mashhad University of Medical Sciences. Patients are randomly divided into two groups of intervention and placebo. Patients in the intervention group receive a lotion containing lactobacillus reuteri strain JCM 1112 twice a day for 4 weeks for their lesions. Patients in the placebo group are treated with a lotion similar to that of the intervention group for 4 weeks. Standard eczema treatments, including skin moisturizers and topical steroids, will be performed on all patients. At the beginning and at the end of week 4, the severity of the lesions is estimated by SCORAD index. Monthly follow-up will be done up to two months later to assess the severity of the disease and the recurrence rate through SCORAD index. In this double-blind study, participants and outcome assessors are unaware of the type of grouping and medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infants and children with atopic dermatitis. Exclusion criteria: Having other allergic diseases, having other skin diseases
Intervention groups
Intervention group: In this group, patients with atopic dermatitis receive a lotion containing lactobacillus reuteri strain JCM 1112 twice a day for 4 weeks for their lesions.
Control group: In this group, patients with atopic dermatitis are treated with a placebo drug which looks like the one in the intervention group twice a day for 4 weeks for their lesions.
Standard treatments for eczema including skin moisturizers and topical steroids, will be performed on all patients.
Main outcome variables
Severity of lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101020004976N8
Registration date:2021-09-08, 1400/06/17
Registration timing:prospective
Last update:2021-09-08, 1400/06/17
Update count:0
Registration date
2021-09-08, 1400/06/17
Registrant information
Name
Hamid Ahanchian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2469
Email address
ahanchianh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-16, 1400/06/25
Expected recruitment end date
2022-02-14, 1400/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of topical probiotic lotion on atopic dermatitis in children
Public title
The effect of topical probiotic lotion on atopic dermatitis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants and children with atopic dermatitis
Exclusion criteria:
Having other allergic diseases
Having other skin diseases
Age
From 1 day old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups control and intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants are not aware of the type of treatment and the intervention. Also, outcome assessors are unaware of the grouping. Patients in the control group receive placebo drug.
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
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-06-15, 1400/03/25
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.254
Health conditions studied
1
Description of health condition studied
atopic dermatitis
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis
Primary outcomes
1
Description
Severity of lesions
Timepoint
At the beginning of the study, at the end of the study in the fourth week and in the first and second months after the end of the study
Method of measurement
Severity Scoring of Atopic Dermatitis (SCORAD)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients with atopic dermatitis receive a lotion containing lactobacillus reuteri strain JCM 1112 (produced by the school of pharmacy of Mashhad University of Medical Sciences) twice a day for 4 weeks for their lesions. Standard treatments for eczema including skin moisturizers and topical steroids, will be performed on all patients.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients with atopic dermatitis are treated with a placebo drug which is a lotion (produced by the school of pharmacy of Mashhad University of Medical Sciences) that looks like the one in the intervention group twice a day for 4 weeks for their lesions. Standard treatments for eczema including skin moisturizers and topical steroids, will be performed on all patients.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Dr Hamid Ahanchian
Street address
Pediatric Allergy department, Ghaem hospital, Ahmad Abad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Email
ahanchianh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
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
Hamid Ahanchian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy
Street address
Ghaem hospital, Ahmad Abad blvd, Mashhad iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 1801 2522
Fax
Email
ahanchianh@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Ahanchian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy
Street address
Ghaem hospital, Ahmad Abad blvd, Mashhad iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 1801 2522
Fax
Email
ahanchianh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Ahanchian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy
Street address
Ghaem hospital, Ahmad Abad blvd, Mashhad iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 1801 2522
Fax
Email
ahanchianh@mums.ac.ir
Web page address
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 can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data can be accessible through an email to the corresponding author.
Under which criteria data/document could be used
Data will be available for researchers in universities and other scientific institutes.
From where data/document is obtainable
After sending a request email to the corresponding author, data will be sent in 1 month.
What processes are involved for a request to access data/document