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The study on the mechanism and influencing factors of intestinal microbiome mediated neurotransmitter changes in behavior and brain development in children with autism spectrum disorders

The study on the mechanism and influencing factors of intestinal microbiome mediated neurotransmitter changes in behavior and brain development in children with autism spectrum disorders

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060362
Enrollment
Unknown
Registered
2022-05-29
Start date
2022-05-18
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Autism spectrum disorders

Interventions

Group 1 :
Group 2:

Sponsors

Xi’an Ninth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Autism Spectrum Disorders (ASD): (1) Meet the diagnostic criteria for autism spectrum disorder in the fifth edition of the American Diagnostic and Statistical Manual of Mental Disorders (DSM-V); (2) The age range is 2-7 years old; (3) Parents (or guardians) voluntarily let children participate in this research and are able to cooperate with the research, and sign the research informed consent; 2. Normal development group (TD): (1) The age range is 2-7 years old; (2) Normal development before and after birth, and no family history of ASD; (3) Parents (or guardians) voluntarily let children participate in this research and are able to cooperate with the research, and sign the research informed consent.

Exclusion criteria

Exclusion criteria: 1. Paticipants with a history of craniotomy; 2. Paticipants who have been installed with cardiac stents, valves and pacemakers; 3. Paticipants with cochlear implants and hearing aids; 4. Paticipants with metallic foreign bodies in the eyeball or various metal implants in the body; 5. Paticipants with history of epilepsy, Tourette syndrome or other brain diseases, such as brain trauma, brain tumor, cerebrovascular disease, encephalitis, cerebral palsy, etc; 6. Paticipants with other diseases that may cause discomfort, such as claustrophobia, severe or recent heart, lung, liver, kidney, gastrointestinal diseases, and acute infectious diseases within one month; 7. There are genetic diseases (such as fragile X syndrome, tuberous sclerosis, phenylketonuria, Rett syndrome, Angelman syndrome, Prader Willi syndrome, intermittent porphyria, etc.); 8. Paticipants with severe allergic history (such as chloral hydrate, etc.); 9. Paticipants with a history of psychotropic drug treatment; 10. Paticipants have taken antibiotics, antifungals, probiotics or performed other gastrointestinal treatments in the last 3 months; 11. There are intestinal organic diseases such as congenital megacolon, intestinal obstruction, intussusception, etc.

Design outcomes

Primary

MeasureTime frame
Intestinal flora;Neurotransmitter;Multidimensional development and behavioral assessment;Brain structure (MRI);Resting state functional magnetic resonance;Intelligence;Metabonomics characteristics of feces;

Secondary

MeasureTime frame
Sleep condition;

Countries

China

Contacts

Public ContactShuhan Yang

Xi’an Ninth Hospital

yangshuhanchina@163.com+86 15398005745

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026