The effect of probiotics on the symptoms and severity of autism disorder will be evaluated.
Design
A one-way clinical trial of 70 autistic children 3 to 18 years of age who are conveniently available to participate in the study.
Settings and conduct
70 children with autism spectrum disorder between the ages of three to 18 years old who is referred to the children and adolescent psychiatric clinic of Imam Hossein Hospital in Tehran or Iran's Autism Association will be selected. This sample will first be evaluated using two CARS and ATEC questionnaires to examine the symptoms and determine the severity of the disorder.
Then all participants will be treated once a day for four weeks with Kidilact probiotics. At the end of the month, children will be evaluated again by the CARS and ATEC questionnaires, and the symptoms and response rates will be reviewed. The results will be analyzed statistically and will be compared with the beginning of the study.
Participants/Inclusion and exclusion criteria
Children from 3 to 18 year old with Autism Spectrum Disorder who do not have chronic infectious disease and AIDS without taking antifungal medication, antibiotic, anti-inflammatory drugs, corticosteroids and anti-diarrheal drugs, enrolled in the study after receiving consent from their parent or caretaker.
Intervention groups
After four weeks, the effect of Kid Lakt on the symptoms and severity of autism in children is evaluated.
Main outcome variables
Changes in the number of symptoms of autism in response to probiotics; changes in the severity of autism in response to probiotics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130504013215N2
Registration date:2018-05-14, 1397/02/24
Registration timing:registered_while_recruiting
Last update:2018-05-14, 1397/02/24
Update count:0
Registration date
2018-05-14, 1397/02/24
Registrant information
Name
Katayoon Razjouyan
Name of organization / entity
Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 1023
Email address
k_razjouyan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation The effect of Probiotics in Reducing Behavioral Symptoms and Severity of Autism in Children and Adolescents with Autism Spectrum Disorder
Public title
Probiotics Effect in Reducing Behavioral Symptoms and Severity of Autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with autism between 3 and 18 years of age
Exclusion criteria:
Suffering from chronic infectious diseases
Congenital metabolic disorders
HIV and Congenital Immunodeficiency Disorder
Under treatment with anti-fungal drugs, antibiotics, anti-inflammatory drugs, corticosteroids, anti-diarrheal compounds, chemotherapy
Age
From 3 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshty University of Medical Sciences
Street address
Imam Hossein Hospital, Madani st.
City
Tehran
Province
Tehran
Postal code
16117763141
Approval date
2016-11-13, 1395/08/23
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.548
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
Change in symptoms of autism disorder in the CARS questionnaire
Timepoint
When entering the study and 8 weeks after starting treatment
Method of measurement
CARS questionnaire at the beginning and the end of the study
2
Description
Change in severity of autism disorder in the ATEC questionnaire
Timepoint
When entering the study and 8 weeks after starting treatment
Method of measurement
ATEC questionnaire at the beginning and the end of the study
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Children with autism disorder are treated with Kidilact probiotics Sache for four weeks. Before entering the study, they filled out the CARS and ATEC questionnaires to measure the symptoms and severity of the disorder. Kidilact Sache is specific for children over 2 years of age that contains high levels of seven beneficial bacterial strains, including the specific strain of children "Bifidobacterium infantis" along with probiotic fructooligosaccharide (contributing to the growth and activity of probiotics). Its formula is specially designed for children to eat it easily. It is consumed by a sachet a day. After 4 weeks, the effect of the drug on the reduction of symptoms and severity of autism disorder is measured by the CARS and ATEC questionnaires.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital- Autism Society of Iran
Full name of responsible person
Katayoon Razjouyan
Street address
Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Email
k_razjouyan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Katayoon Razjouyan
Street address
Imam Hossein Hospital- Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Email
k_razjouyan@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
30
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Katayoon Razjouyan
Position
Assistant Professor of Child and Adolescent Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Fax
+98 21 7755 1023
Email
k_razjouyan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Katayoon Razjouyan
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Madani
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Email
k_razjouyan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Katayoon Razjouyan
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Medani street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Email
k_razjouyan@sbmu.ac.ir
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
Demographic information such as gender and age, without mentioning the name is shared.
When the data will become available and for how long
The access period starts from 2019.
To whom data/document is available
Researchers on Autism Spectrum Disorders
Under which criteria data/document could be used
For use in similar studies on children with developmental disorders
From where data/document is obtainable
Use the responsible person's email
What processes are involved for a request to access data/document
After the presentation of evidence from well-known research centers to conduct a similar study, files will be available up to one month.