UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026157 |
|---|---|
| Receipt number | 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 06:00:44 |
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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
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
khaled.ali@med.au.edu.eg
Sponsor or person
Institute
Ain Shams University, Cairo, Egypt
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030041
