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To study the mechanism and influencing factors of probiotics on children with autism spectrum disorder from the perspective of immunology

To study the mechanism and influencing factors of probiotics on children with autism spectrum disorder from the perspective of immunology

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046330
Enrollment
Unknown
Registered
2021-05-14
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

autism spectrum disorder

Interventions

Normal development group:Nil
Intervention control group:Rehabilitation training
Intervention trial group:Probiotics combined with rehabilitation training

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of ASD in DSM-5; 2. Aged 3 to 8 years; 3. The child was voluntarily enrolled in the group, and his guardian agreed to participate in the study and signed an informed consent form; 4. Not receive gastrointestinal treatment within 1 month before enrollment, no antibiotics and probiotics are used.

Exclusion criteria

Exclusion criteria: 1. Autism-like manifestations caused by other diseases; 2. Children with other mental diseases, craniocerebral organic diseases, severe liver and kidney diseases, cardiovascular diseases, etc.; 3. History of probiotic allergy in children.

Design outcomes

Primary

MeasureTime frame
Area and number of eczema and urticaria;Peripheral blood samples detect IL-4, IL-6, IL-17a and IL-10 levels and analyze the number of T helper cells (Th1, Th2, Th17) and regulatory T cells (Treg);

Secondary

MeasureTime frame
Fecal intestinal flora detection;Fecal metabolite detection;Physical development assessment;Cognitive ability assessment;Nervous system development assessment;Gastrointestinal conditions such as dietary conditions and stool conditions;

Countries

China

Contacts

Public ContactHan Ying

Peking University First Hospital

hanying1568@126.com+86 13661013288

Outcome results

None listed

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