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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026157
Receipt No. R000030041
Scientific Title The Role of Probiotics in Children with Autism Spectrum Disorder: a prospective, open-label study.
Date of disclosure of the study information 2017/03/01
Last modified on 2017/03/08

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Basic information
Public title The Role of Probiotics in Children with Autism Spectrum Disorder: a prospective, open-label study.
Acronym Probiotics in Autism Spectrum Disorder.
Scientific Title The Role of Probiotics in Children with Autism Spectrum Disorder: a prospective, open-label study.
Scientific Title:Acronym 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
1st name
Middle name
Last name Shaaban SY
Organization Ain Shams University, Cairo, Egypt
Division name Pediatric Department, Faculty of Medicine,
Zip code
Address Cairo, Egypt
TEL +201223148425
Email dryasmingamal@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name Khaled Saad
Organization Faculty of Medicine - Assiut University
Division name Pediatric Department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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