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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041606
Receipt No. R000047489
Scientific Title Gut microbiome of patients with autism spectrum disordersand attention deficit/hyperactivity disorders: A cross sectional study
Date of disclosure of the study information 2020/08/31
Last modified on 2020/08/29

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Basic information
Public title Gut microbiome of patients with autism spectrum disordersand attention deficit/hyperactivity disorders: A cross sectional study
Acronym Gut microbiome of patients with ASD and ADHD (GMAA study)
Scientific Title Gut microbiome of patients with autism spectrum disordersand attention deficit/hyperactivity disorders: A cross sectional study
Scientific Title:Acronym Gut microbiome of patients with ASD and ADHD (GMAA study)
Region
Japan

Condition
Condition Autism Spectrum Disorders: ASD Attention Deficit/Hyperactivity Disorders: ADHD
Classification by specialty
Gastroenterology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We collect feces samples from patients with autism spectrum disorders (ASD) and attention deficit/hyperactivity disorders (ADHD), and healthy controls (HCs). Clinical information will also be collected with severity of each disease, lifestyle habits, and gastrointestinal symptoms .
The purpose of this study is to investigate the difference between intestinal bacterial flora and its metabolites in each group and to examine the relationship between intestinal bacterial flora and neuropsychiatric function.
Basic objectives2 Others
Basic objectives -Others Gut microbiota profiles assessed by 16SrRNA and its metabolites by performing mass spectrometry.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gut microbiota profiles assessed by 16SrRNA and its metabolites by performing mass spectrometry.
Key secondary outcomes ・Original questionnaire of lifestyles
・Brief-type self-administered Diet History Questionnaire: BDHQ
・Autism-spectrum quotient: AQ-J
・Conners' Adult ADHD Rating Scales: CAARS
・Social Functioning Scale: SFS
・Adolescent / Adult Sensory Profile: AASP
・Japanese Adult Reading Test: JART
・Pittsburgh Sleep Quality Index: PSQI
・Gastrointestinal Symptom Rating Scale: GSRS
・Original questionnaire of Gastro-intestinal Symptom

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria <Patients with autism spectrum disorders: ASD or attention deficit/hyperactivity disorders: ADHD>
・Age between 20 and 50 at the time of agreement.
・Patients with ASD or ADHD admitted to the Showa University Karasuyama Hospital or the Keio University Hospital.

<Healthy participants>
・People who are willing to participate in this study without the history of psychiatric disorders.
・Age between 20 and 50 at the time of agreement.
Key exclusion criteria ・Participants with dementia.
・Participants with gastrointestinal disorder.
・Participants who are receiving the antibiotic treatment.
・Participants who can not agree with collecting faces samples.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Sanada
Organization Showa University School of Medicine
Division name Department of Psychiatry
Zip code 157-8577
Address 6-11-11Kitakarasuyama Setagaya-ku, Tokyo, Japan
TEL 03-3300-5232
Email ksanappu@gmail.com

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Tachibana
Organization Showa University School of Medicine
Division name Department of Psychiatry
Zip code 157-8577
Address 6-11-11Kitakarasuyama Setagaya-ku, Tokyo, Japan
TEL 03-3300-5232
Homepage URL
Email tachibanat@showa-u.med.ac.jp

Sponsor
Institute Showa University School of Medicine
Department of Psychiatry
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Keio University School of Medicine
Department of Nueropsychiatry
Institute for Advanced Biosciences, Keio University
Name of secondary funder(s)

IRB Contact (For public release)
Organization lnstitutional Review Board of ShowaUniversity Karasuyama Hospital
Address 6-11-11Kitakarasuyama Setagaya-ku, Tokyo, Japan
Tel 03-3300-5247
Email showa-crc@ofc.showa-u.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 昭和大学附属烏山病院(東京都)
慶應義塾大学病院(東京都)
慶應義塾大学先端生命科学研究所(山形県)

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 31 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 17 Day
Date of IRB
2020 Year 08 Month 21 Day
Anticipated trial start date
2020 Year 08 Month 31 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We collect feces samples from patients with autism spectrum disorders (ASD) and attention deficit/hyperactivity disorders (ADHD), and healthy controls (HCs). Clinical information will also be collected with severity of each disease, lifestyle habits, and gastrointestinal symptoms .
The purpose of this study is to investigate the difference between intestinal bacterial flora and its metabolites in each group and to examine the relationship between intestinal bacterial flora and neuropsychiatric function.

Management information
Registered date
2020 Year 08 Month 29 Day
Last modified on
2020 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047489

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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