Autism spectrum disorder
Conditions
Sponsors
Southwest Medical University Affiliated Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 14 Years
Inclusion criteria
Inclusion criteria: (1)Children aged 3-14, male or female. (2)Meet the diagnostic criteria for Autism Spectrum Disorder as defined by the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). (3)Study participants or their guardians can fully understand the contents of the informed consent for this trial and voluntarily sign the informed consent form. (4)Able to attend follow-up visits on time, undergo follow-up examinations, and provide samples, including blood, urine, and stool samples.
Exclusion criteria
Exclusion criteria: (1)Severe fever or serious infection within 7 days prior to enrollment. (2)History of brain injury, cerebral palsy, encephalitis, or other organic brain diseases, or diagnosed with other mental disorders including Rett syndrome, depression, attention deficit hyperactivity disorder, selective mutism, reactive attachment disorder, or childhood schizophrenia. (3)Previous diagnosis of organic gastrointestinal diseases and serious gastrointestinal issues requiring immediate treatment, such as congenital megacolon, intestinal perforation, gastrointestinal bleeding, intestinal obstruction, intussusception, inflammatory bowel disease, celiac disease, or eosinophilic esophagitis. (4)Diagnosed with severe obesity or severe malnutrition. (5)Severe immunodeficiency disorders. (6)Use of probiotics, prebiotics, antibiotics, or other drugs that may affect the gut microbiota in the past 3 months, or plans to use these drugs in the next 4 months. (7)Received fecal microbiota transplantation (FMT) treatment within the past 12 months. (8)Dependent on tube feeding. (9)Severe allergy history. (10)Monogenic diseases. (11)Patients unable to comply with the study requirements. (12)Other patients whom the researchers deem unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Childhood Autism Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Autism Treatment Evaluation Checklist;Gastrointestinal Symptom Rating Scale;Autism Behavior Checklist;Social Responsiveness Scale;Daily Stool Record;Children's Sleep Habits Questionnaire;Changes in intestinal microecology and metabolic markers in serum and urine.;Self-Rating Anxiety Scale; | — |
Countries
China
Contacts
Public ContactLv Muhan
Southwest Medical University Affiliated Hospital
Outcome results
None listed