Autism spectrum disorder
Conditions
Interventions
Probiotic Group:Probiotic Lactobacillus plantarum ST-III powder + maltodextrin, take one packet daily dissolved in warm water for 12 consecutive weeks.
Placebo group:Maltodextrin (placebo), one packet mixed with warm water daily, taken continuously for 12 weeks.
Sponsors
Shanghai Children’s Hospital
Eligibility
Sex/Gender
All
Age
18 Months to 15 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with ASD according to the diagnostic criteria for ASD in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V); Aged between 18 months and 15 years; Presenting with gastrointestinal symptoms (such as dyspepsia, constipation, diarrhea, etc.).
Exclusion criteria
Exclusion criteria: Children with schizophrenia and other psychoses defined by the DSM-V criteria, excluding those with comorbid mood disorders and ASD; Seizures in the past year; A history of severe head injury or stroke; Suffering from severe infectious or communicable diseases; Having taken antibiotics, probiotics, or acid suppressants in the past one month; Having received fecal microbiota transplantation treatment in the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The score of the Childhood Autism Rating Scale (CARS);The score of the Autism Behavior Rating Scale (ABC);The score of the Social Responsiveness Scale (SRS);The score of the Gastrointestinal Symptom Rating Scale (GSRS); | — |
Secondary
| Measure | Time frame |
|---|---|
| The score of the Sleep Disturbance Scale for Children (SDSC); | — |
Countries
China
Contacts
Public ContactZhang Ting
Shanghai Children’s Hospital
Outcome results
None listed