UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033163 |
|---|---|
| Receipt number | 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 | 2024/07/01 22:47:21 |
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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 | 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
tkishimoto@z7.keio.jp
Public contact
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
tkishimoto@z7.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Neuropsychiatry dpt
Institute
Department
Personal name
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
Keio University School of Medicine Ethics Review Subcommittee
Address
35 Shinanomachi
Tel
0333531211
keio-ctr-coijim@adst.keio.ac.jp
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
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000033163
Publication of results
Published
Result
URL related to results and publications
https://acamh.onlinelibrary.wiley.com/doi/full/10.1111/jcpp.13962
Number of participants that the trial has enrolled
98
Results
The alpha-diversity indices, such as Chao 1 and Shannon index, showed a significant difference between the groups in a Linear mixed-effect model (F(4, 93) = 4.539, p = .02), (F(4, 93) = 3.185, p = .017), respectively. In a post-hoc pairwise comparison, patients with ASD had lower alpha-diversity compared with non-related controls after Bonferroni correction.
Results date posted
| 2024 | Year | 07 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ninety-eight subjects were included in the study (18 with ASD, 19 with ADHD, 20 with both ASD and ADHD, 13 neurotypical siblings, and 28 non-related neurotypical controls).
Participant flow
Outpatients from Keio University Hospital (Tokyo, Japan) and Shimada Ryoiku Medical Center for Challenged Children (Tokyo, Japan) were recruited.
Adverse events
None
Outcome measures
Microbiome Alpha diversity measures.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
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
| 2024 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037580
