UMIN-CTR Clinical Trial

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
Email	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
Email	taretare@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039474