The effect of Gluten-free diet on gastrointestinal symptoms and disease severity of Autistic children
Design
Double-blinded randomized clinical trial on 80 patients with parallel groups
Settings and conduct
All patients with autism referred to Sheikh Al-Rais Clinic and Tabriz Children's Hospital will be included in the study. The diagnosis of autism is made by neurologists and psychologists and the M-CHAT rf questionnaire will be completed for patients. The project nurse who divides the patients and analyzes the study data were blinded to the intervention groups.
Participants/Inclusion and exclusion criteria
Patients with autism spectrum disorders in the patient, the presence of gastrointestinal symptoms such as abdominal pain, vomiting, constipation and diarrhea, parental consent and adherence to the treatment regimen and the age of two to sixteen years will be included in the study. Patients will be excluded from the study if their parents do not agree to follow a gluten-free diet and have other known gastrointestinal or neurological problems.
Intervention groups
The intervention group will receive a gluten-free diet at a normal meal and the control group will receive a normal diet.
Main outcome variables
Severity of autism, abdominal pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046137N2
Registration date:2021-06-07, 1400/03/17
Registration timing:prospective
Last update:2021-06-07, 1400/03/17
Update count:0
Registration date
2021-06-07, 1400/03/17
Registrant information
Name
Shahram Sadeghvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2280
Email address
sadeghvandsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Gluten-free diet on gastrointestinal symptoms and disease severity of Autistic children
Public title
Gluten-free diet in Autistic children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of autism spectrum disorders in the patient
Gastrointestinal symptoms such as heartburn, vomiting, constipation and diarrhea
Parental satisfaction and adherence to the treatment regimen
Age two to sixteen
Exclusion criteria:
Parents' dissatisfaction with following a gluten-free diet
Having other known gastrointestinal or neurological problems
Age
From 2 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be using sealed envelopes, of which 80 envelopes will be selected in total and will be divided into two groups of 40, including groups A and B. Envelopes will be selected by the neurology ward's nurse who is blind to the study groups. Group A will be the intervention group, group B will be the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The project nurse who divides the patients and analyzes the study data in relation to the blind intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah Square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-04-26, 1400/02/06
Ethics committee reference number
IR.TBZMED.REC.1400.089
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Autism severity
Timepoint
Initiation of the study, 3 months after the intervention
Method of measurement
M-Chat-RF questionnaire
2
Description
Abdominal pain
Timepoint
Initiation of the study, 3 months after the intervention
Method of measurement
Clinical examination and visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will receive a gluten-free diet at normal meals.
Category
Treatment - Other
2
Description
Control group: They will receive a normal routine diet.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Dr. Mir Hadi Mousavi
Street address
Tabriz Children Hospital, Sheshgelan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5157664988
Phone
+98 41 3526 2256
Email
sadeghvandsh@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
samiei.moh@gmail.com
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
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shahram Sadeghvand
Position
Pediatric neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children Hospital, Seshghelaan St., Seggat ol Eslam Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
Email
shahram.sadeghvand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shahram Sadeghvand
Position
Pediatric neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children Hospital, Seshghelaan St., Seggat ol Eslam Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
Email
shahram.sadeghvand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shahram Sadeghvand
Position
Pediatric neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children Hospital, Seshghelaan St., Seggat ol Eslam Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
Email
shahram.sadeghvand@yahoo.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
No - There is not 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
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.