Autism Spectrum Disorder
Conditions
Interventions
Group A:FMT Live Bacteria Capsules Combined with Transcranial Magnetic Stimulation
Group B:FMT Live Bacterial Capsules Combined with Pseudotranscranial Magnetic Stimulation
Group C:Placebo Capsules Combined with Transcranial Magnetic Stimulation
Group D:Placebo Capsules Combined with Sham Transcranial Magnetic Stimulation
Sponsors
Tianjin Anding Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age: 3 - 12 years old, gender not restricted; 2. Meets the diagnostic criteria for autism as per the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) of the United States; 3. Capable of swallowing oral capsules; 4. Normal liver and kidney functions; 5. No concurrent other acute or chronic organic diseases; 6. The individual voluntarily agrees and the guardian consents and signs the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria for FMT 1. Use of antibiotics within 1 month or presence of active infection; 2. Comorbid with organic lesions of organs such as heart, lungs, liver, and kidneys; 3. Suffering from other mental disorders or neurological diseases, such as bipolar disorder, obsessive-compulsive disorder, epilepsy, etc.; 4. Previous history of abdominal surgery; 5. Comorbid with metabolic system, endocrine system, or autoimmune system diseases; 6. Comorbid with genetic diseases or genetic disorders; 7. Currently participating in other interventional clinical trials; 8. Any other situation as determined by the investigator to be unsuitable for inclusion; The following are the FMT contraindications indicated in the expert consensus, and the following conditions also need to be excluded: 1. Severe immunosuppression; 2. Severe intestinal mucosal damage or undetermined intestinal mucosal injury; 3. Fulminant colitis, toxic megacolon; 4. Severe diarrhea, intestinal stenosis, gastrointestinal bleeding, high-flow intestinal fistula, etc., patients who cannot tolerate enteral nutrition; 5. Comorbid with severe infection, systemic inflammatory response syndrome (SIRS); 6. Extraintestinal organ infections requiring broad-spectrum antibiotics; 7. Severe malnutrition or hypoproteinemia; 8. Congenital immune deficiency diseases; 9. Recent high-risk immunosuppressive/cytotoxic drug treatment; 10 Pregnant or lactating women. Exclusion criteria for transcranial magnetic stimulation 1. Severe organic brain diseases, such as epilepsy, stroke, encephalitis, brain trauma, or severe somatic diseases such as malignant tumors, acute heart failure, multiple organ failure, etc.; 2. Metal implants above the chest, especially in the brain or heart; 3. Receiving electroconvulsive therapy (ECT) within 6 months; 4. Within the past year, history of drug and alcohol abuse; 5. Speech communication difficulties to the extent that they cannot communicate normally, understand or follow instructions, cooperate with treatment and assessment; 6. Currently participating in other drug or physical therapy (such as deep brain stimulation DBS, ECT therapy, rTMS); 7. The doctor deems it inappropriate to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Social Responsiveness Scal;Autism Diagnostic Observation Schedule - Second Edition; | — |
Secondary
| Measure | Time frame |
|---|---|
| Repetitive Behavior Questionnaire-2;Autism Behavior Checklist;Imaging examination;Electroencephalogram Acquisition;Eye-tracking test; | — |
Countries
China
Contacts
Public ContactZhang Bin
Tianjin Anding Hospital
Outcome results
None listed