Efficacy of Pidrolax With or Without A Gluten-Free Diet on Gastrointestinal Symptoms and Behavioral Of Autistic Children with Gastrointestinal Disorders
This randomized clinical trial with a control group has been done to compare the effects of Pidrolax with or without the gluten-free diet on intensity of autism symptoms and gastrointestinal disorders in children with autism. 120 children with autism located in Autism Centers of Guilan 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, 65 screened children, were randomly divided into two intervention and control groups. In both groups Pidrolax powder at a dose of 25-12 grams per day for a period of time (no symptoms of constipation), in the intervention group also gluten-free diet (about 200 grams of wheat gluten) and the control group of about 200 grams of cereals containing gluten, was used for 3 months. At the end, two tests were repeated and the questionnaires were evaluated
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110915339N1
Registration date:2016-09-18, 1395/06/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-18, 1395/06/28
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
private
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 Pidrolax With or Without A Gluten-Free Diet on Gastrointestinal Symptoms and Behavioral Of Autistic Children with Gastrointestinal Disorders
Public title
Pidrolax With or Without A Gluten-Free Diet on Gastrointestinal Symptoms and Behavioral Of Autistic Children
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:
65
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/k
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
2
Description
Gastrointestinal symptoms
Timepoint
Before and three months after intervention.
Method of measurement
GSRS Questionnaire and Visual Scale of Pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pidrolax powder at a dose of 25-10 grams per day for a period of time, for 3 months. Gluten-free diet( bread, biscuits, pasta, cakes and a variety of cookies without gluten). about 200 grams per day for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Pidrolax powder at a dose of 25-10 grams per day for a period of time, for 3 months. Gluten diet( bread, biscuits, pasta, cakes and a variety of cookies with gluten,normal diet), about 200 grams per day for 3 months.