UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Role of Probiotics in Children with Autism Spectrum Disorder: a prospective, open-label study.
Title of the study (Brief title)	Probiotics in Autism Spectrum Disorder.
Region	Africa

Condition
Condition	ASD
Classification by specialty	Pediatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study was designed to evaluate the role of probiotics supplementation in improving the gastrointestinal symptoms, the general and mental health of the autistic children at the age of 5 to 9 years old.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gastrointestinal symptoms of autistic children were assessed with a modified six-item Gastrointestinal Severity Index(6-GSI)questionnaire, and autistic symptoms were assessed with the Autism Treatment Evaluation Checklist(ATEC)before and after 3 months of supplementation of autistic children with a probiotic nutritional supplement formula(each gram contains 100 x106 colony forming units of different probiotic strains).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Children with Autism Spectrum Disorder.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	5 years-old <=
Age-upper limit	9 years-old >=
Gender	Male and Female
Key inclusion criteria	Children with Autism Spectrum Disorder.
Key exclusion criteria	children on anti-fungal or antibiotic in the last 3 months were excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	Shaaban SY
Organization	Ain Shams University, Cairo, Egypt
Division name	Pediatric Department, Faculty of Medicine,
Address	Cairo, Egypt
TEL	+201223148425
Email	dryasmingamal@yahoo.com

Public contact
Name of contact person	Khaled Saad
Organization	Faculty of Medicine - Assiut University
Division name	Pediatric Department
Address	Assiut University, Assiut, Egypt
TEL	+20882413683
Homepage URL
Email	khaled.ali@med.au.edu.eg

Sponsor
Institute	Ain Shams University, Cairo, Egypt
Institute
Department

Funding Source
Organization	Ain Shams University, Cairo, Egypt
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 01 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2017 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030041