Autism spectrum disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age 2-18 years old, male or female; (2) Meeting the diagnostic criteria of ASD in the fifth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) of the American Psychiatric Association; (3) Accompanied by gastrointestinal symptoms such as diarrhea, constipation, abdominal distension, dyspepsia, abnormal gastrointestinal exhaust, food allergy/intolerance for at least 6 months, and the above symptoms have occurred in the past 3 months; (4) The subjects and/or their guardians signed the informed consent, agreed to cooperate with the whole process of the clinical trial and to collect clinical data.
Exclusion criteria
Exclusion criteria: (1) Diagnosis of Rett syndrome. (2) Previous history of brain injury, cerebral palsy, encephalitis or other brain organic diseases; (3) Diagnosis of other mental diseases; (4) Diagnosis of intestinal organic diseases, such as congenital megacolon, intestinal obstruction, intussusception, inflammatory bowel disease and etc. (5) There are pathological intestinal inflammatory changes, such as inflammatory bowel disease (6) Severe obesity or severe malnutrition (7) There is a planned use of probiotics and antibiotics in the past 3 months or in the next 6 months drugs that sound intestinal flora; (8) Have received FMT treatment in the past 12 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diversity and richness of flora;Assessment of ASD Symptoms;Assessment of bowel symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| The a diversity and ß diversity of intestinal flora increased from baseline;Changes in symptoms of other comorbidities such as allergy, asthma, dermatitis, and metabolic syndrome in patients; | — |
Countries
China
Contacts
Shanghai Tenth People’s Hospital