Autism Spectrum DisorderNCT05038748
A Pilot Study of Microbiome in Patients With Autism Spectrum Disorder and Their Unaffected Siblings
An observational study of Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The primary aims are to identify important gut microbiota signatures for youth with ASD, to identify dysbiosis features for different levels of ASD features and clinical courses, to search the possibility to intervene the disease course if we can tease out the dysbiosis responsible for the flare-up and improvement of… Read more about this study
- Who is it for?
- Ages 7 to 25 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Psychiatric diagnosis and ASD diagnosis
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The cohort was established at the Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007.
Who may be able to join
- a clinical diagnosis of ASD defined by the DSM-IV confirmed by ADI-R or ADOS and also clinical reappraisal based on the newly release DSM-5 criteria for ASD
- ages range from 7 to 25 at the time now
- at least one biological parent
- parents that are both Han Chinese in Taiwan
Who cannot join
- intellectual disability
- epilepsy
- ADHD
- autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Microbiome in Patients With Autism Spectrum Disorder and Their Unaffected
The primary aims are to identify important gut microbiota signatures for youth with ASD, to identify dysbiosis features for different levels of ASD features and clinical courses, to search the possibility to intervene the disease course if we can tease out the dysbiosis responsible for the flare-up and improvement of the symptoms of the disease. The secondary aims are to identify the clinical and neuropsychological measures that are associated with direct and indirect regulation or interactions from gut-brain axis signaling, and based our preliminary results on reducing the measures for future large-scale microbiome study in ASD.
Read the detailed description
Background: Despite increased public awareness of autism spectrum d isorder (ASD) and extensive research on this neurodevelopmental disorder in the past decades, the underlying mechanisms of ASD remain unclear, and ASD is still recognized as having the highest disease and care burden among child psychiatric disorders regarding its long-term impairment across the lifespan. Hence, identifying the biomarkers for early detection and effective biological treatments for ASD is among the most challenging tasks all over the world. The concerns about physical comorbidities such as immune dysregulation, allergy, and gastrointestinal issues, etc. emerged in the recent decade. Hence, the new perspective of searching for the underlying mechanism for ASD also targets the associations between microbiota and ASD. However, despite many microbiome studies in ASD, they provided limited knowledge about the specific link that particular imbalance gut bacteria could affect the behavioral deficits in ASD because lack of consideration of the clinical and genetic heterogeneity of ASD. With only a few studies examining the well-defined ASD-related impairments, the GI system dysfunction, and the microbiomes, the associations among ASD-related symptoms, GI symptoms, and microbiota remain indistinct. Therefore, the investigators propose this pilot study to fill the gap between the potential role of microbiome as a biomarker for ASD to facilitate developing the treatment for ASD.
Method and material: The case-sibling control study design will be used to investigate microbiome in 60 probands with ASD, aged 7-25 yrs old, and 30 unaffected siblings either from the PI Gau's ASD cohort or the Department of Psychiatry, National Taiwan University Hospital. The parents of all the subjects will receive the Autism Diagnostic Interview-Revised (ADI-R) interviews and report on the questionnaires regarding autistic symptoms, emotional/behavioral problems, social functions, G-I symptoms, and life quality. The ASD and sibling subjects will receive the Autism Diagnostic Observation Scale and neuropsychological tasks. The experiment of microbiome will be conducted by the core lab of microbiome (co-PI Ni) at the college of medicine, National Taiwan University. The data analyses will combine microbiomics and the extensive behaviors/cognitive function variables to establish an objective potential pipeline.
Anticipated outcome: With the accomplishment of this project, the investigators will establish the comprehensive yet fewer bios for the ASD risk bio-factors in Asia, and provide the potential clinical interview and assessments related to GI symptoms regulated by microbiota. The potential biomarkers may be further used to developing the treatment for ASD.
Significance: Several features of this project constitute its significance: a wealth of measures of ASD phenotypes (valid phenotype), ASD as a catastrophic disease (importance), the first ASD study with unaffected sibling design for microbiomics studies in ASD (originality), and new approaches and technologies (novelty) for searching microbiomics in ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Psychiatric diagnosis, ASD diagnosis
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric diagnosisOther
Kiddie Schedule for Affective Disorders \& Schizophrenia (K-SADS) for DSM-5
ASD diagnosisOther
Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)
| Study group | Role | What they receive |
|---|---|---|
| ASD group | 80 youths with the clinical diagnosis of ASD according to the DSM-5 diagnostic criteria Receives: Other: Psychiatric diagnosis; Other: ASD diagnosis | |
| Sibling group | 30 unaffected siblings of ASD youths Receives: Other: Psychiatric diagnosis | |
| TD group | 40 healthy typical developing(TD) control from cohort established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007 Receives: Other: Psychiatric diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Diagnostic Interview-Revised (ADI-R)
Including reciprocal social interaction, communication, and repetitive behaviors and stereotyped patterns, for children with a mental age from about 18 months into adulthood. The coding of some items is converted to numeric scores "0" if no evidence of abnormality exists, "1" if some evidence of abnormality exists, and "2" if evidence of marked abnormality. Higher scores mean more severe clinical deficits.
Measured: 1 hour
Autism Diagnostic Observation Scale (ADOS)
Including communication, social interaction, creativity, stereotyped behaviors and restricted interests. The coding of some items is converted to numeric scores "0" if no evidence of abnormality exists, "1" if some evidence of abnormality exists, and "2" if evidence of marked abnormality. Higher scores mean more severe clinical deficits.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038748
- Sponsor's protocol ID
- 201810048RIND
- Status last verified
- Jan 2021
- First submitted
- 1 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Microbiome in Patients With Autism Spectrum Disorder and Their Unaffected
- ClinicalTrials.gov ID
- NCT05038748
- Acronym / sponsor ID
- 201810048RIND
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aims are to identify important gut microbiota signatures for youth with ASD, to identify dysbiosis features for different levels of ASD features and clinical courses, to search the possibility to intervene the disease course if we can tease out the dysbiosis responsible for the flare-up and improvement of the symptoms of the disease. The secondary aims are to identify the clinical and neuropsychological measures that are associated with direct and indirect regulation or interactions from gut-brain axis signaling, and based our preliminary results on reducing the measures for future large-scale microbiome study in ASD.
Detailed description
Background: Despite increased public awareness of autism spectrum d isorder (ASD) and extensive research on this neurodevelopmental disorder in the past decades, the underlying mechanisms of ASD remain unclear, and ASD is still recognized as having the highest disease and care burden among child psychiatric disorders regarding its long-term impairment across the lifespan. Hence, identifying the biomarkers for early detection and effective biological treatments for ASD is among the most challenging tasks all over the world. The concerns about physical comorbidities such as immune dysregulation, allergy, and gastrointestinal issues, etc. emerged in the recent decade. Hence, the new perspective of searching for the underlying mechanism for ASD also targets the associations between microbiota and ASD. However, despite many microbiome studies in ASD, they provided limited knowledge about the specific link that particular imbalance gut bacteria could affect the behavioral deficits in ASD because lack of consideration of the clinical and genetic heterogeneity of ASD. With only a few studies examining the well-defined ASD-related impairments, the GI system dysfunction, and the microbiomes, the associations among ASD-related symptoms, GI symptoms, and microbiota remain indistinct. Therefore, the investigators propose this pilot study to fill the gap between the potential role of microbiome as a biomarker for ASD to facilitate developing the treatment for ASD.
Method and material: The case-sibling control study design will be used to investigate microbiome in 60 probands with ASD, aged 7-25 yrs old, and 30 unaffected siblings either from the PI Gau's ASD cohort or the Department of Psychiatry, National Taiwan University Hospital. The parents of all the subjects will receive the Autism Diagnostic Interview-Revised (ADI-R) interviews and report on the questionnaires regarding autistic symptoms, emotional/behavioral problems, social functions, G-I symptoms, and life quality. The ASD and sibling subjects will receive the Autism Diagnostic Observation Scale and neuropsychological tasks. The experiment of microbiome will be conducted by the core lab of microbiome (co-PI Ni) at the college of medicine, National Taiwan University. The data analyses will combine microbiomics and the extensive behaviors/cognitive function variables to establish an objective potential pipeline.
Anticipated outcome: With the accomplishment of this project, the investigators will establish the comprehensive yet fewer bios for the ASD risk bio-factors in Asia, and provide the potential clinical interview and assessments related to GI symptoms regulated by microbiota. The potential biomarkers may be further used to developing the treatment for ASD.
Significance: Several features of this project constitute its significance: a wealth of measures of ASD phenotypes (valid phenotype), ASD as a catastrophic disease (importance), the first ASD study with unaffected sibling design for microbiomics studies in ASD (originality), and new approaches and technologies (novelty) for searching microbiomics in ASD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | Other: Psychiatric diagnosis, Other: ASD diagnosis80 youths with the clinical diagnosis of ASD according to the DSM-5 diagnostic criteria |
| Sibling group | – | Other: Psychiatric diagnosis30 unaffected siblings of ASD youths |
| TD group | – | Other: Psychiatric diagnosis40 healthy typical developing(TD) control from cohort established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007 |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The cohort was established at the Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007.
Key inclusion criteria (4 listed)
- a clinical diagnosis of ASD defined by the DSM-IV confirmed by ADI-R or ADOS and also clinical reappraisal based on the newly release DSM-5 criteria for ASD
- ages range from 7 to 25 at the time now
- at least one biological parent
- parents that are both Han Chinese in Taiwan
Key exclusion criteria (4 listed)
- intellectual disability
- epilepsy
- ADHD
- autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric diagnosisKiddie Schedule for Affective Disorders \& Schizophrenia (K-SADS) for DSM-5 | Other | ASD group, Sibling group, TD group |
| ASD diagnosisAutism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS) | Other | ASD group |
Primary outcome
Autism Diagnostic Interview-Revised (ADI-R)
Time frame: 1 hour
Including reciprocal social interaction, communication, and repetitive behaviors and stereotyped patterns, for children with a mental age from about 18 months into adulthood. The coding of some items is converted to numeric scores "0" if no evidence of abnormality exists, "1" if some evidence of abnormality exists, and "2" if evidence of marked abnormality. Higher scores mean more severe clinical deficits.
Autism Diagnostic Observation Scale (ADOS)
Time frame: 1 hour
Including communication, social interaction, creativity, stereotyped behaviors and restricted interests. The coding of some items is converted to numeric scores "0" if no evidence of abnormality exists, "1" if some evidence of abnormality exists, and "2" if evidence of marked abnormality. Higher scores mean more severe clinical deficits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Diagnostic Interview-Revised (ADI-R) (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.