Autism-spectrum disorder
Conditions
Interventions
Control group:Oral placebo
High dose group:Lactobacillus reuteri CGMCC25664 oral daily 2*10^10 CFU
Small dose group:Lactobacillus reuteri CGMCC25664 oral daily 1*10^10 CFU
Sponsors
Dalian Women and Children's Medical Group
Eligibility
Sex/Gender
All
Age
2 Years to 7 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for autism in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for children and the diagnostic criteria for autism in the Second Edition of the Chinese Classification and Diagnosis of Mental Disorders (CCMD-2). 2. The Childhood Autism Rating Scale (CARS) score is >= 30. 3. Age range: 2-7 years old (less than 7 years old), gender not restricted.
Exclusion criteria
Exclusion criteria: 1. Excluding other extensive developmental disorders and clear genetic autism 2. Use of antibiotics, probiotics or other gastrointestinal treatment within 1 month prior to enrollment 3. Patients with comorbidities such as epilepsy, ADHD 4. Any behavior that prevents the interpretation of clinical judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal microecology metagenome;Autism Behavior Checklist;ABC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytokines IL-4;Cytokines IL-6;Cytokines IL-8;Cytokines IFN-?;Cytokines TNF-a; | — |
Countries
China
Contacts
Public ContactSun Jin
Dalian Women and Children's Medical Group
Outcome results
None listed