Effectiveness of the gluten free diet and gluten containing diet on gastrointestinal and behavioral indices for children with Autism Spectrum Disorders
In this study, 80 children diagnosed with Autism spectrum Disorders attending the rehabilitation center for children with ASD are going to be studied. The aim of this study is to determine the effect of gluten free diet intervention on ASD and gastrointestinal symptoms. Inclusion criteria consist of: patients diagnosed with ASD, age between 4-16 years, also the exclusion criteria are: healthy children not diagnosed with ASD and unwilling to participate in the study. Participants will be divided into two groups of 40. One group will be achieving 200 g gluten free grains and the second group will receive 200 g grains containing gluten in the duration of 6 weeks intervention. At the baseline and at the end of the study a demographic questionnaire, GARS-2 and a questionnaire for evaluating gastrointestinal symptoms will be completed by interviewing parents. Also anthropometric measures including weight, height and BMI will be calculated and assessed. Additionally 5 ml blood sample will be taken after a night fasting by a laboratory technician at the rehabilitation center for children with ASD, in the beginning and at the end of the intervention. The blood samples will be centrifuged and stored at -80° C. Anti-tissue transglutaminase IgA antibodies (tTGA) will be analyzed by chemiluminescence immunoassay system and total serum IgA levels will be analyzed by nephrometry scoring system.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404212017N20
Registration date:2014-05-27, 1393/03/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-27, 1393/03/06
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of the gluten free diet and gluten containing diet on gastrointestinal and behavioral indices for children with Autism Spectrum Disorders
Public title
The effect of gluten free diet on gastrointestinal and behavioral indices in children with ASD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients diagnosed with ASD ; age between 4-16 years; capable of eating food; willing to participate in the study
Exclusion criteria: chidren without ASD; pursuing a particular diet; unwilling to participate in the study
Age
From 4 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Attar Alley, Golgasht Street, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2014-04-14, 1393/01/25
Ethics committee reference number
937
Health conditions studied
1
Description of health condition studied
Childhood Autism
ICD-10 code
F84.0
ICD-10 code description
Childhood Autism
Primary outcomes
1
Description
Behavioural Symptoms
Timepoint
Before and After 6 Weeks Intervention
Method of measurement
Gilliam Autism Rating Scale Questionare
2
Description
Gastrointestinal Symptoms
Timepoint
Before and After 6 Weeks of Intervention
Method of measurement
Shahid Beheshti Questionare for Gastrointestinal Symptoms
3
Description
Tissue Transglutaminase Immunoglobulin A
Timepoint
Before and after 6 weeks of intervention
Method of measurement
Chemiluminescence Immunoassay System
4
Description
Immunoglobulin A
Timepoint
Before and after 6 weeks of intervention
Method of measurement
Nephrometry
Secondary outcomes
1
Description
Body Mass Index
Timepoint
Before and after 6 weeks of intervention
Method of measurement
Weight/Height*2
Intervention groups
1
Description
Gluten Free Diet: Gluten free bread, biscuit, pasta
Category
Lifestyle
2
Description
Gluten containing diet: Regular bread, biscuit, pasta
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized treatment and rehabilitation center for children with pervasive developmental disorder
Full name of responsible person
Faezeh Ghalichi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Poor gaseme Gargari
Street address
Attar Alley, Golgasht Street, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
PHD in Nutrition Sciences
Other areas of specialty/work
Street address
Attar Alley, Golgasht Street, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
Ostadrahimi@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
PHD in Nutrition Sciences
Other areas of specialty/work
Street address
Attar Alley, Golgasht Street, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
Ostadrahimi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Faezeh Ghalichi
Position
MSc student in nutrition sciences
Other areas of specialty/work
Street address
Attar Alley, Golgasht Street, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1327 0748
Fax
Email
Faezeh.Ghalichi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)