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Research on the Role of Intestinal 5-HydroxyTryptamine Signaling and Intestinal Flora in the Pathogenesis of Children with Autism

Research on the Role of Intestinal 5-HydroxyTryptamine Signaling and Intestinal Flora in the Pathogenesis of Children with Autism

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116165
Enrollment
Unknown
Registered
2026-01-06
Start date
2026-01-07
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Autism Spectrum disorder

Interventions

Observation group:None
Control group:None

Sponsors

Wenling Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged between 2 and 8 years who have previously been diagnosed with ASD, or who are diagnosed with ASD by senior specialists from the research team according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), exhibiting social interaction deficits, communication difficulties, repetitive and stereotyped behaviors, developmental abnormalities, etc.; 2. The ADOS-2 Autism Diagnostic Observation Schedule is chosen as the main auxiliary diagnostic tool, and ADOS-2 is currently considered the "gold standard" for clinical diagnosis of autism in children both domestically and internationally; 3. The primary caregiver or parents agree to participate in the study, complete relevant specimen collection, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Children with congenital diseases or chromosomal abnormalities; 2. Children with other neurodevelopmental disorders such as obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, or selective mutism; 3. Children with immune system or hematological dysfunction, or those with heart, liver, or kidney insufficiency; 4. Children with organic gastrointestinal diseases, acute gastrointestinal diseases, or infectious diseases.

Design outcomes

Primary

MeasureTime frame
Determination of 5-HT levels in children's blood, detection of 5-HT in feces, and analysis of intestinal flora structure;Collection of biological specimens for experimental animals and behavioral testing;

Secondary

MeasureTime frame
General clinical information (general demographic information of the children, maternal exposure to toxic drugs during pregnancy, delivery method, dietary preferences, sleep problems, feeding methods, the severity of social communication impairments in children with autism, repetitive stereotyped behaviors, gastrointestinal function impact, degree of social support, and social adaptation ability);

Countries

China

Contacts

Public ContactShuhong Zheng

Wenling Maternal and Child Health Hospital, Zhejiang Province

zshuhong78@126.com+86 136 0667 1760

Outcome results

None listed

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