Autism spectrum disorder
Conditions
Interventions
Fecal microbiota transplantation group:Fecal microbiota transplantation, routine rehabilitation and dietary intervention
Control group:Routine rehabilitation and dietary intervention
Sponsors
Shanghai Children’s Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Aged 3 to 17 years; 2. Meet DSM-V criteria, the total score of CARS >= 30 points; 3. Autism Behavior Rating Scale (ABC) >= 67 points; 4. Complicated with gastrointestinal symptoms; 5. The legal guardian fully understood and signed the informed consent, agreeing to collect clinical data and peripheral blood and stool samples; 6. Continued participation in the project and follow-up for 6 months.
Exclusion criteria
Exclusion criteria: 1. Rett syndrome was definitely diagnosed; 2. With other serious systemic diseases and a clear history of organic brain diseases such as brain trauma, cerebral palsy and encephalitis; 3. Those who have been explicitly diagnosed with other mental diseases; 4. Use of probiotics, antibiotics, acid suppressors and other drugs affecting intestinal microbiota in the last 3 months; 5. Complicated with other serious gastrointestinal diseases, intestinal organic lesions such as congenital megacolon, intestinal obstruction, intussusception, etc.; 6. Poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean GSRS score of the subjects decreased by > 50% after treatment;The incidence of free and hard stools (type 1 or 2) and soft and liquid stools (type 6 or 7) decreased after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The scores of the Childhood Autism Rating Scale (CARS), the Autism Behavior Rating Scale (ABC) and the Social Response Scale (SRS) decreased; | — |
Countries
China
Contacts
Public ContactZhang Ting
Shanghai Children’s Hospital
Outcome results
None listed