Autism spectrum disorder
Conditions
Interventions
Sponsors
Shenzhen Children’s Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 12 Years
Inclusion criteria
Inclusion criteria: (1) Children between the ages of 2 and 12; (2) Moderate to severe autism diagnosed with autism spectrum disorder according to the DSM-5 diagnostic criteria and scored by the Children's Autism Rating Scale (CARS) with a total score of =36; The main diagnostic points of DSM-5 are as follows: ?Early onset and development; ?Persistent deficits in social interaction and communication and limited, repetitive patterns of behavior, interests, or activities in multiple contexts; ?The symptoms cause clinically significant impairment in social, occupational, or other currently important functions; ?The above symptoms are not better explained by intellectual disability (intellectual development disorder) or global developmental delay. The Childhood Autism Rating Scale (CARS) is a commonly used diagnostic tool. There are 15 items in the scale. Each item is graded at 4 levels. A total score of <30 is classified as non-autism, a total score of 30-36 is classified as mild to moderate autism, and a total score of =36 is classified as moderate to severe autism. (3) Patients whose guardians can fully understand the informed consent content of this experiment and voluntarily sign a written informed consent; (4) Be able to receive revisits, follow-up examinations and specimens on time; (5) Have not taken probiotic preparations in the past 3 months.
Exclusion criteria
Exclusion criteria: (1) Taking probiotics or prebiotics within 3 months before enrollment; (2) Antibiotics were used within 1 month before enrollment; (3) Fever; (4) dependent on tube feeding; (5) have a serious gastrointestinal problem requiring immediate treatment (such as life-threatening intestinal obstruction, intestinal perforation, intestinal bleeding, ulcerative inflammatory colon, Crohn's disease, celiac disease, or eosinophilic esophagitis); (6) diagnosis of severe malnutrition or underweight or severe immunodeficiency; (7) Have a history of severe allergies; (8) Single gene disease; (9) have also been diagnosed with a mental disorder or depression; The diagnosis is developmental speech or language disorder, intellectual development disorder, attention deficit hyperactivity disorder, selective mutism, reactive attachment disorder, or childhood schizophrenia. (10) Patients who are unable to complete the study; (11) Other patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GSRS;CARS; | — |
Secondary
| Measure | Time frame |
|---|---|
| bacterial colonization and the core flora;DSR;SRS;ABC; | — |
Countries
China
Contacts
Public ContactZhongsheng Zhu
Shenzhen Children’s Hospital
Outcome results
None listed