Autistic spectrum disorder
Conditions
Interventions
intervention group:Bifidobacterium lactate M8
control group:placebo
Sponsors
Shenzhen Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. The diagnostic criteria for patients diagnosed with autism are: according to the diagnostic and Statistical Manual of mental disorders (Fifth Edition, DSM - V) published by the American Psychiatric Association, the child psychiatrist or rehabilitation physician (above deputy director) should be responsible for the diagnosis of autism; 2. Subjects aged from 3 to 12 years old, regardless of gender; 3. Subjects receiving oral administration of Bifidobacterium lactate M8 and low-carbon balanced diet instruction; 4. The subjects who can complete the study according to the requirements of the trial protocol; 5. Subjects without known immunodeficiency diseases; 6. Subjects and / or guardians can fully understand the content of informed consent and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Subjects diagnosed with severe malnutrition; 2. Subjects with severe gastrointestinal diseases (or life-threatening) requiring immediate treatment; 3. Patients with known monogenic diseases; 4. Patients with severe allergic history; 5. Patients with severe fever and / or severe infection within 7 days before enrollment; 6. Patients with renal insufficiency and liver dysfunction (or creatinine > 2 mg / dl, direct bilirubin > 2 mg / dl); 7. Patients with inflammatory bowel disease, intestinal obstruction, intestinal perforation, intestinal bleeding, celiac disease, irritable bowel syndrome or eosinophilia, esophagitis, eosinophilic gastroenteritis or similar diseases; 8. Subjects with severe sensory or motor problems (e.g., blindness, deafness, seizures, cerebral palsy); 9. Patients who are participating in other clinical studies, or received interventions of other interventional clinical studies within 4 weeks before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CARS; | — |
Countries
China
Contacts
Public ContactCuifeng Zhu
Shenzhen Hospital of Southern Medical University
Outcome results
None listed