UMIN-CTR Clinical Trial

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

Autism Spectrum Disorder, Attention Deficit Hyperactive Disorder

Classification by specialty

Psychiatry

Child

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name	Taishiro
Middle name
Last name	Kishimoto

Organization

Keio University School of Medicine

Division name

Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes

Zip code

106-0032

Address

Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan

TEL

03-5786-0006

Email

tkishimoto@z7.keio.jp

Name of contact person

1st name	Taishiro
Middle name
Last name	Kishimoto

Organization

Keio University School of Medicine

Division name

Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes

Zip code

106-0032

Address

Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan

TEL

03-5786-0006

Homepage URL

Email

tkishimoto@z7.keio.jp

Institute

Keio University School of Medicine
Neuropsychiatry dpt

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Keio University School of Medicine Ethics Review Subcommittee

Address

35 Shinanomachi

Tel

0333531211

Email

keio-ctr-coijim@adst.keio.ac.jp

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

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）

Date of disclosure of the study information

2018

Year

06

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2018

Year

04

Month

27

Day

Date of IRB

2018

Year

04

Month

27

Day

Anticipated trial start date

2018

Year

06

Month

27

Day

Last follow-up date

2023

Year

04

Month

10

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

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.

Registered date

2018

Year

06

Month

27

Day

Last modified on

2022

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037580