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A Cross sectional Study of Fecal Microbiome among Japanese Children with Autistic Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Their Siblings and Typically Developing Children

A Cross sectional Study of Fecal Microbiome among Japanese Children with Autistic Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Their Siblings and Typically Developing Children - Gut Microbiome of Children with Autistic Spectrum Disorder and Attention Deficit Hyperactivity Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000033163
Enrollment
160
Registered
2018-06-27
Start date
2018-06-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Attention Deficit Hyperactive Disorder

Interventions

None listed

Sponsors

Keio University School of Medicine Neuropsychiatry dpt
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTaishiro Kishimoto

Keio University School of Medicine Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes

tkishimoto@z7.keio.jp03-5786-0006

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026