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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033163
Receipt No. R000037580
Scientific Title A Cross sectional Study of Fecal Microbiome among Japanese Children with Autistic Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Their Siblings and Typically Developing Children
Date of disclosure of the study information 2018/06/27
Last modified on 2018/10/30

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Basic information
Public title A Cross sectional Study of Fecal Microbiome among Japanese Children with Autistic Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Their Siblings and Typically Developing Children
Acronym Gut Microbiome of Children with Autistic Spectrum Disorder and Attention Deficit Hyperactivity Disorder
Scientific Title A Cross sectional Study of Fecal Microbiome among Japanese Children with Autistic Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Their Siblings and Typically Developing Children
Scientific Title:Acronym Gut Microbiome of Children with Autistic Spectrum Disorder and Attention Deficit Hyperactivity Disorder
Region
Japan

Condition
Condition Autism Spectrum Disorder, Attention Deficit Hyperactive Disorder
Classification by specialty
Psychiatry Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We collect feces samples from Japanese children with either ASD or ADHD, their siblings and typically developing children. Clinical Information will also be collected together with severity of each disease and lifestyle habits.
The purpose of this study is to investigate the difference between intestinal bacterial flora and its metabolites in each group and to examine the interaction between intestinal bacterial flora and neuropsychiatric function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Feces samples will be collected at least 3 times during one month period.
Bacterial metagenome and metabolomics will be assessed with 16SrRNA methodology and Mass spectrometry
Key secondary outcomes To Patients
Autism Diagnostic Observation Schedule: ADOS-2
Childhood Autism Rating Scale: CARS

To parents or caregivers of all children
Original questionnaire of lifestyles and Growth history
Brief-type self-administered Diet History
Questionnaire: BDHQ
Autism-spectrum quotient: AQ-J
Conners 3
Abberant Behavior Checklist: ABC-J
Sensory Profile: SP
Gastrointestinal Symptom Rating Scale: GSRS
Original questionnaire of Gastrointestinal Symptom

Base
Study type Observational

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
6 years-old <=
Age-upper limit
13 years-old >
Gender Male and Female
Key inclusion criteria <In cases of ASD, ADHD children>
(including co-existence of ASD and ADHD)
Age above 6 years old and less than 13 years old at the time of agreement.

<In cases of their siblings>
Age above 6 years old and less than 13 years old at the time of agreement.

<In cases of healthy participants>
Typically developing children who are willing to participate in the study
without family history of psychiatric disorders.
Age above 6 years old and less than 13 years old at the time of agreement
Key exclusion criteria <In cases of ASD, ADHD children>
Having other mental disorders, organic brain abnormalities (epilepsy, schizophrenia, obsessive-compulsive disorder, etc.)
Having serious systemic physical disorders (thyroid dysfunction, immune diseases, etc.)
Underwent surgery due to serious gastrointestinal disorder or in treatment of severe gastrointestinal disorders(gastrointestinal cancer, congenital bowel obstruction, Hirschsprung disease etc.)
Received antibiotics within 3 months
Collection of fecal samples can not be performed for any reason (such as mental symptoms can be worsened due to stress, etc.)
Psychological symptoms may worsen due to mental and physical burden caused by interview evaluation conducted in this research
Other reasons in which researchers considered to be inappropriate

<In cases of their siblings>
Having serious systemic physical disorders (thyroid dysfunction, immune diseases, etc.)
Having undergone surgery due to serious gastrointestinal disorder or in treatment of severe gastrointestinal disorders(gastrointestinal cancer, congenital bowel obstruction, Hirschsprung disease etc.)
Received antibiotics within 3 months
Collection of fecal samples can not be performed for some reason
Large burden caused by interview evaluation conducted in this research
Other reasons in which researchers considered to be inappropriate

<In cases of healthy participants>
Family history of mental illness within the second degree,
Having serious systemic physical disorders (thyroid dysfunction, immune diseases, etc.)
Having undergone surgery due to serious gastrointestinal disorder or in treatment of severe gastrointestinal disorders(gastrointestinal cancer, congenital bowel obstruction, Hirschsprung disease etc.)
Received antibiotics within 3 months
Collection of fecal samples can not be performed for some reason
Large burden caused by interview evaluation conducted in this research
Other reasons in which researchers considered to be inappropriate
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taishiro Kishimoto
Organization Keio University School of Medicine
Division name department of Neuropsychiatry
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo, Japan 160-8582
TEL 03-5363-3829
Email tkishimoto@z7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taishiro Kishimoto
Organization Keio University School of Medicine
Division name department of Neuropsychiatry
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo, Japan 160-8582
TEL 03-5363-3829
Homepage URL
Email tkishimoto@z7.keio.jp

Sponsor
Institute Keio University School of Medicine
Neuropsychiatry dpt
Institute
Department

Funding Source
Organization Keio Gijuku Academic Development Funds, Kawano Masanori memorial foundation, Otsuka, MOCHIDA, SHIONOGI, Meiji,Takeda. SENSHIN, Astellas, Sumitomo Dainippon, Mitsubishi Tanabe.
Organization
Division
Category of Funding Organization Profit organization
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 YES
Study ID_1 20180024
Org. issuing International ID_1 Keio University School of Medicine Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 慶應義塾大学病院(東京都)
島田療育センター(東京都)
駒木野病院(東京都)
東京都立小児総合医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 27 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 Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Children clinically diagnosed as ASD or ADHD, will be recruited. Their siblings, typically developing children will also be recruited. Each group include maximum of 40 subjects.

<In the cases of children with ASD / ADHD>
Hospitalized patients:
During the hospital stay, stool samples will be collected 1 - 3 times within a period of 1 month.
Also, the following tests for ASD severity evaluation will be carried out.
Autism Diagnostic Observation Schedule (ADOS-2)
Childhood Autism Rating Scale (CARS)

In addition, the following 8 self-report questionnaires will be conducted with the caregivers' assistance to evaluate the severity of the developmental disorder, evaluation of gastrointestinal symptoms, growth history and lifestyle habits.
Original Growth history and Lifestyle survey form
Brief-type self-administered Diet History Questionnaire(BDHQ)
Autism-spectrum quotient (AQ-J)
Conners 3 (Conners 3)
Abnormal Behavior Checklist (ABC-J)
Sensory Profile (SP)
Gastrointestinal Symptom Rating Scale (GSRS)
Original simple survey on gastrointestinal symptoms

Outpatient cases:
Stool samples will be collected in the same time period. Same 8 self-report questionnaires will be carried out. ADOS-2 and CARS will be set on another day within 1 month from obtaining consent.

<In case of siblings and healthy children>
Stool samples will be collected in the same time period. Same 8 self-report questionnaires will be carried out.

The stool data collected by the above method will be analyzed using the combination of metabolomics and metagenomics method, and information of the intestinal environment will be integrated.
Relationship between participants' severity, gastrointestinal symptoms, dietary habits, and the intestinal microbiota will be investigated.

Management information
Registered date
2018 Year 06 Month 27 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037580

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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