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Fecal Microbiota Preparation Treatment for Autism Spectrum Disorder: A Prospective, Open-label, Randomized, Controlled Trial

Fecal Microbiota Preparation Treatment for Autism Spectrum Disorder: A Prospective, Open-label, Randomized, Controlled Trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16008468
Enrollment
Unknown
Registered
2016-05-12
Start date
2016-05-26
Completion date
Unknown
Last updated
2021-09-28

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

Conditions

Autism Spectrum Disorder

Interventions

Wait List Control Group:N/A, Control

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 25 Years

Inclusion criteria

Inclusion criteria: 1. Patients who fulfilled the diagnosis criteria of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; 2. Patients aged 3-25 years old, no sex limited; 3. Voluntarily participated in the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with an allergy to anesthetics; 2. Patients taking immunosuppressive drugs; 3. Subjects with fragile X syndrome, tuberous sclerosis; 4. History of disease caused by karyotype abnormalities and/or neuroolgical antecedents (including epilepsies and febrile seizure); 5. Taking all kinds of antibiotics, probiotics, diet therapy, high doses of vitamin in one month.

Design outcomes

Primary

MeasureTime frame
Childhood Autism Rating Scale;Autism Diagnostic Observation Schedule;

Secondary

MeasureTime frame
Autism Diagnostic Interview-Revised;Records about the adverse effects of patients after treatment;Conner Parent Symptom Questionnaire;Child Behavior Checklist;Fecal Metabolites;eye tracking research;Gastreointestinal Symptom Index;Clinical Global Impressions ;Fecal Microbiota Chinges;

Countries

China

Contacts

Public ContactYunsheng Yang

Chinese PLA General Hospital

sunny301ddc@126.com+86 010-55499005

Outcome results

None listed

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