Autism Spectrum Disorder
Conditions
Interventions
Intervention group:LR99 Probiotics
Sponsors
Peking University Sixth Hospital ( Institute of Mental Health )
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1.Aged 2-6 years old (inclusive of the boundary values), male or female, no restriction; 2.Based on the clinical evaluation by child psychiatrists with the title of attending physician or above, the subjects meet the diagnostic criteria for Autism Spectrum Disorder in the "Diagnostic and Statistical Manual of Mental Disorders, 5th Edition" (DSM-5); 3.The guardian understands and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Accompanied by neurological diseases such as epilepsy, tuberous sclerosis, and encephalitis; 2.Those with inflammatory bowel disease, congenital megacolon, or other digestive system diseases, or those who have previously undergone gastrointestinal surgery; 3.Accompanied by metabolic diseases such as abnormal glucose regulation, diabetes, and hypoglycemia; 4.accompanied by genetic diseases such as trisomy 21 syndrome, Turner syndrome, and fragile X syndrome; 5.Those with a history of malignant tumors or currently suffering from active malignant tumors, including intracranial tumors; 6.Abnormalities in electrocardiogram results with clinical significance or abnormalities in laboratory test results; 7.Having used probiotics, antibiotics, or other drugs that clearly affect the intestinal flora in the past month, or planning to use them during the research process; 8.Have received FMT treatment within the past 12 months; 9.Those who have participated in other clinical trials within 1 month before enrollment; 10.Those with a history of allergies to any component of the test product or similar drugs;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Childhood Autism Rating Scale (CARS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the Denver Developmental Screening Test (DDST);Changes in the intestinal flora;Changes in the Autism Spectrum Quotient (ASQ);Changes in the Bristol Stool Form Scale (BSFS);Common Terminology Criteria for Adverse Events Scale;Changes in the Autism Behavior Checklist (ABC);Changes in the Social Responsiveness Scale (SRS) for Children;cytokine;The proportion of cases that withdrew early due to poor therapeutic effect;Changes in the Clinical Global Impression - Severity of Illness Scale (CGI-S);Changes in the Revised Repetitive Behaviors Scale (RBS-R);Changes in the Clinical Global Impression - Improvement Scale (CGI-I);Changes in the Gastrointestinal Symptom Rating Scale (GSRS);Semi-quantitative Food Frequency Questionnaire (FFQ);Changes in oral flora;Changes in the Autism Treatment Evaluation Checklist (ATEC);Changes in the Achenbach Child Behavior Checklist (CBCL);Changes in annual growth rate; | — |
Countries
China
Contacts
Public ContactYang Li
Peking University Sixth Hospital ( Institute of Mental Health )
Outcome results
None listed