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Intervention Study on Fecal Microbiota Transplantation and Transcranial Magnetic Stimulation for Improving Core Symptoms in Children and Adolescents with Autism Spectrum Disorder

Intervention Study on Fecal Microbiota Transplantation and Transcranial Magnetic Stimulation for Improving Core Symptoms in Children and Adolescents with Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101087
Enrollment
Unknown
Registered
2025-04-20
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorder

Interventions

Transcranial Magnetic Stimulation (TMS) Group:Transcranial magnetic stimulation (TMS) intervention
Normal Control Group:None

Sponsors

Tianjin Anding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Aged 6–18 year; 2.Meets the diagnostic criteria for autism spectrum disorder (ASD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3.Normal liver and kidney function; 4.No concurrent acute or chronic organic diseases; 5.Voluntary participation with informed consent signed by both the participant (if capable) and their legal guardian.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for FMT Group: 1.Use of antibiotics within the past month or presence of active infection; 2.Organic diseases of the heart, lungs, liver, kidneys, or other major organs; 3.Comorbid psychiatric or neurological disorders (e.g., bipolar disorder, obsessive-compulsive disorder, epilepsy); 4.History of abdominal surgery; 5.Metabolic, endocrine, or autoimmune system disorders; 6.Genetic or chromosomal disorders; 7.Current participation in another interventional clinical trial; 8.Any other condition deemed unsuitable for enrollment by the investigators. Exclusion Criteria for TMS Group: 1.Severe organic brain diseases (e.g., epilepsy, stroke, encephalitis, traumatic brain injury) or severe systemic diseases (e.g., malignant tumors, acute heart failure, multi-organ failure); 2.Presence of metal implants above the chest, particularly in the brain or heart (contraindications for magnetic stimulation); 3.History of electroconvulsive therapy (ECT) within the past 6 months; 4.Substance or alcohol abuse within the last year; 5.Severe communication impairments affecting comprehension, compliance with instructions, or ability to cooperate with treatment and assessments; 6.Current participation in other drug or physical therapies (e.g., deep brain stimulation (DBS), ECT, or repetitive transcranial magnetic stimulation (rTMS)); 7.Any other condition considered unsuitable by the physician.

Design outcomes

Primary

MeasureTime frame
Social Responsiveness Scale;Autism Behavior Checklist;Autism Diagnostic Observation Schedule;

Secondary

MeasureTime frame
Gut microbiota analysis;Magnetic Resonance Imaging ;Electroencephalography;Eye-tracking;

Countries

China

Contacts

Public ContactZhang Bin

Tianjin Anding Hospital

zhang.bin845@foxmail.com+86 189 8893 2815

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026