UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034625 |
|---|---|
| Receipt number | R000039474 |
| Scientific Title | Usefulness of water soluble dietary fiber as a therapy for children with Autism Spectrum Disorder |
| Date of disclosure of the study information | 2019/01/30 |
| Last modified on | 2021/12/13 09:14:49 |
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Basic information
Public title
Usefulness of water soluble dietary fiber as a therapy for children with Autism Spectrum Disorder
Acronym
Effect of water soluble dietary fiber on children with Autism Spectrum Disorder
Scientific Title
Usefulness of water soluble dietary fiber as a therapy for children with Autism Spectrum Disorder
Scientific Title:Acronym
Effect of water soluble dietary fiber on children with Autism Spectrum Disorder
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of ingestion of water soluble dietary fiber on gut microbiota and serum inflammatory cytokines in children with autism spectrum spectrum disorder is evaluated. The composition of gut microbiota and concentration of serum inflammatory cytokines are evaluated before and after ingestion of water soluble dietary fiber.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in gut microbiota and serum inflammatory cytokines before and after ingestion of water soluble dietary fiber.
Duration of the ingestion is at least 4 weeks.
Key secondary outcomes
Change in frequency of defecation and behavioral symptom evaluated by ABC-J before and after ingestion of water soluble dietary fiber.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of water soluble dietary fiber at least 6g per day.
Duration of the ingestion is at least 4 weeks.
Ingestion can be achieved by any method. Water soluble dietary fiber can be supplemented to any of food and drink.
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
| 2 | years-old | < |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as autism spectrum disorder by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.
2. Having food preference and/or constipation
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Sakaue |
Organization
Shiga University of Medical Science
Division name
Department of Pediatrics
Zip code
520-2192
Address
Tsukinowa, Seta, Otsu, Shiga
TEL
077-548-2228
taretare@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Sakaue |
Organization
Shiga University of Medical Science
Division name
Department of Pediatrics
Zip code
520-2192
Address
Tsukinowa, Seta, Otsu, Shiga
TEL
077-548-2228
Homepage URL
taretare@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto Prefectural University
Name of secondary funder(s)
Taiyo Kagaku Corporation
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Tsukinowa, Seta, Otsu, Shiga
Tel
077-548-3576
hqrec@belle.shiga-med.ac.jp
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
| 2019 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jcbn/64/3/64_18-105/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jcbn/64/3/64_18-105/_pdf/-char/ja
Number of participants that the trial has enrolled
13
Results
Ingestion of soluble dietary fibre for more than 2 months improved gut microbiota, constipation and irretability.
Results date posted
| 2021 | Year | 12 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Children with ASD in the ragen of 4-9 years of age. They were pre-categorized by DSM-5 and then diagnosed according to PARS and M-CHAT.
Participant flow
Due to the limited comprehensino of ASD children who acted as donors, written informed consent was obtained from their paretns.
Adverse events
None
Outcome measures
Gut microbiota
Freqeuencty of defecation
ABC-J
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 24 | Day |
Last modified on
| 2021 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039474
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
