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Efficacy of A Gluten-Free Diet on Behavioral Of Autistic Children Without Gastrointestinal Disorders

Protocol summary

Summary
This randomized clinical trial with a control group has been done to determine the effect of gluten-free diet on behavioral symptoms of autistic children without gastrointestinal disorders. 120 children with autism located in autism centers of Gilan and Mazandaran were evaluated. Autism Spectrum Disorders and age range of 3-15 years old were the inclusion criteria and not having the symptoms of autism and unwillingness to participate in the study were exclusion criteria of the study. In the clinical interview, questionnaires of Gilliam Autism Rating (GARS1) to assess the severity of symptoms of autism and Gastrointestinal Symptom Rating Scale (GSRS) to screening for autistic children with gastrointestinal disorders, was completed by parents. Then, 29 screened children, were randomly divided into two intervention and control groups. In the intervention group, gluten-free diet (gluten-free cereals about 200 grams per day) and in the control group around 200 grams of cereals containing gluten have been included for 3 months. At the end, GARS1 was repeated in both groups and the questionnaire were evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016082215339N2
Registration date: 2016-09-12, 1395/06/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-12, 1395/06/22
Registrant information
Name
Ali Akbar Esmaeliranjbar
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 1613
Email address
esmaeli@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
personal
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-01-05, 1390/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of A Gluten-Free Diet on Behavioral Of Autistic Children Without Gastrointestinal Disorders
Public title
Efficacy of A Gluten-Free Diet on Behavioral Of Autistic Children Without Gastrointestinal Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: autism Exclusion criteria: not having the symptoms of autism and unwillingness to participate in research
Age
From 3 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 29
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
Ethics committee of Kerman University of Medical Sciences
Street address
No. 24, Ebnesina St, Jahad Blvd.,Somayeh Cross.
City
Kerman
Postal code
7619813159
Approval date
2013-08-27, 1392/06/05
Ethics committee reference number
92/220/کا

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
Symptoms of Autism
Timepoint
Before and three months after intervention.
Method of measurement
GARS Questionnaire and Visual Scale of Behaviors

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Gluten-free diet( bread, biscuits, pasta, cakes and a variety of cookies without gluten), about 200 grams per day for 3 months
Category
Lifestyle

2

Description
Control group:Gluten diet( bread, biscuits, pasta, cakes and a variety of cookies with gluten), about 200 grams per day for 3 months
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Ayandeh
Full name of responsible person
Fatemeh Rabiae
Street address
No. 14, Shabani 2nd Alley, Khoshkalam Alley, Gas square toward Tooshiba, Rasht.
City
Rasht

2

Recruitment center
Name of recruitment center
Besharat
Full name of responsible person
Mahin Poor Mohamad
Street address
No. 23, Amoo blind alley, next to the Guilan sport, Imam St., Shahrdari square, Rasht.
City
Rasht

3

Recruitment center
Name of recruitment center
Mansoor
Full name of responsible person
Mahin Dokht Azarney
Street address
No. 9, across Hajbaba bakery, Ershad alley, Ansari Blvd.
City
Rasht

4

Recruitment center
Name of recruitment center
ShadPooya
Full name of responsible person
Sheyda Khanzadeh
Street address
No. 12, Shahid Esmaeil Nezhad Moghadam Alley, Vahedi St., Anzalee.
City
Anzalee

5

Recruitment center
Name of recruitment center
Afra
Full name of responsible person
Elham Akbari
Street address
No. 55, Mirzaye Shirazi Alley, Jomhoori St.,
City
Tonekabon.

6

Recruitment center
Name of recruitment center
Shahid Babaee
Full name of responsible person
Mrs Balassi
Street address
No.45, Opposit Krym Abad Park,
City
Tonekabon.

7

Recruitment center
Name of recruitment center
Shahid Baraghi
Full name of responsible person
Hamideh Ghanbari
Street address
No. 18, Baghmeli St.
City
Ramsar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Islamic Azad University of Tonekabon
Full name of responsible person
Hosein Ali Mashayekhi
Street address
Islamic Azad University - Tonekabon Branch, Vali Abad,
City
Tonekabon
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Islamic Azad University of Tonekabon
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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Amini Ranjbar
Position
Master of Clinical Psychology
Other areas of specialty/work
Street address
Kerman University of Medical Sciences, International Campus. Haft Bagh.
City
Kerman
Postal code
7614745969
Phone
+98 34 3223 7337
Fax
+98 34 3211 1613
Email
aminiranjbar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Amini Ranjbar
Position
Master of Clinical Psychology
Other areas of specialty/work
Street address
Kerman University of Medical Sciences, International Campus. Haft Bagh. Kerman
City
Kerman
Postal code
7614745969
Phone
+98 34 3223 7337
Fax
+98 34 3211 1613
Email
aminiranjbar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Health Technology Incubator Center, Vice chancellor for research, Kerman University of Medical Scien
Full name of responsible person
Ali Akbar Esmaeili
Position
Director of the Center
Other areas of specialty/work
Street address
No. 3, between Farhangian and Keshavarz crosses, Jomhoori Blvd
City
Kerman
Postal code
7614745969
Phone
+98 34 3211 4535
Fax
+98 34 3211 1613
Email
esmaeliranjbar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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