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IRCT20130504013215N2 IRCT 2018-05-14 Shahid Beheshti University of Medical Sciences Probiotics Effect in Reducing Behavioral Symptoms and Severity of Autism Evaluation The effect of Probiotics in Reducing Behavioral Symptoms and Severity of Autism in Children and Adolescents with Autism Spectrum Disorder 2017-09-23 anticipated 70 Complete https://irct.ir/trial/29018 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Autism Spectrum Disorder. 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.. Yes - There is a plan to make this available What will be shared: Demographic information such as gender and age, without mentioning the name is shared. When: The access period starts from 2019. To whom: Researchers on Autism Spectrum Disorders Conditions: For use in similar studies on children with developmental disorders Where to obtain: Use the responsible person's email How to obtain: After the presentation of evidence from well-known research centers to conduct a similar study, files will be available up to one month. Comments:
public Katayoon Razjouyan
Shahid Madani Street
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7755 1023 k_razjouyan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Katayoon Razjouyan
Shahid Madani
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7755 1023 k_razjouyan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients with autism between 3 and 18 years of age 3 years 18 years Both 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 F84.0 Childhood autism Treatment - Drugs 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. 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. 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. Shahid Beheshti University of Medical Sciences Approved 2016-11-13 Ethics committee of Shahid Beheshty University of Medical Sciences Imam Hossein Hospital, Madani st. Tehran Tehran Iran (Islamic Republic of)