Autism spectrum disorder (ASD)
Conditions
Interventions
Precision Microbiota Transplantation capsule treatment group:Precision Microbiota Transplantation capsule
FMT capsule treatment group:FMT capsule
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
3 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, children and adolescents aged 3-14 years old; 2. Diagnosis of ASD in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-V); 3. Accompanied by gastrointestinal symptoms such as diarrhea, constipation, abdominal pain, bloating, and/or food allergies/intolerances, which appeared for at least 14 days; 4. Patients whose guardians can fully understand the content of informed consent for this trial and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have taken antibiotics and probiotics within 1 month before enrollment; 2. Have serious gastrointestinal problems that require immediate treatment (such as life-threatening intestinal obstruction, intestinal perforation, intestinal bleeding); 3. Concurrent use of drugs related to mental disorders or depression (such as antidepressant drugs fluoxetine and sertraline, anti-anxiety drug lorazepam); 4. Dependent on tube feeding feeding; 5. Have swallowing dysfunction and cannot be taken with capsules; 6. Have a history of severe allergies; 7. Those who are conducting other clinical studies at the time of enrollment or within 4 weeks before enrollment; 8. Patients with poor compliance, difficulty in completing follow-up, and other reasons deemed by the investigator to be unsuitable for enrollment or subjects withdrawing from the trial due to their own reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Behavioral Rating Scale (ABC) scores of children with autism before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Childhood Autism Rating Scale of children with autism before and after treatment;Changes in Social Responsiveness Scale of children with autism before and after treatment;Changes in Self-Rating Anxiety Scale of children with autism before and after treatment;Changes in Autism Diagnostic Observation Schedul of children with autism before and after treatment;Changes in Gastrointestinal Symptom Rating Scale of children with autism before and after treatment;Changes in Serum (5-HT, GABA, Dopamine) of children with autism before and after treatment;Changes in gut gut microbiota of children with autism before and after treatment; | — |
Countries
China
Contacts
Public ContactYanling Wei
Department of Gastroenterology, Army Medical Center of PLA
Outcome results
None listed