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The Prospective Study of Fecal Microbiota Transplantation for Improving Early Atypical Autism Spectrum Disorder

The Randomized Controlled Study of Fecal Microbiota Transplantation for Improving Early Atypical Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097424
Enrollment
Unknown
Registered
2025-02-19
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Early Atypical Autism Spectrum Disorder

Interventions

Control group:Conventional rehabilitation therapy

Sponsors

Shanghai Children’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.8 Years to 3 Years

Inclusion criteria

Inclusion criteria: Meet the diagnostic criteria for EAASD: According to the DC: 0-5 Diagnostic Classification of Infants and Early Childhood Psychological and Developmental Disorders, infants and young children aged 9-36 months show severe social communication abnormalities and restrictive and repetitive behaviors, but do not fully meet the diagnostic criteria for ASD (American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition). Age: 9-36 months. Consent of legal guardian: The guardian fully understands the content of the study and signs the informed consent form, agreeing to the investigator to collect clinical data and samples. Compliance: Able to participate in the program on an ongoing basis and complete 12 weeks of follow-up.

Exclusion criteria

Exclusion criteria: Combined with other serious systemic diseases: such as cardiovascular diseases, respiratory diseases, etc. History of organic diseases of the brain: such as traumatic brain injury, cerebral palsy, encephalitis, etc. Organic intestinal lesions: such as Hirschsprung's disease, intestinal obstruction, intussusception, etc. Recent use of drugs that affect the intestinal flora: use of probiotics, antibiotics, antacids, etc. in the past 3 months. Poor compliance: Inability to complete the study process or follow-up as required. Other special circumstances: such as unstable vital signs, or situations that the investigator considers unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
The score of the Childhood Autism Rating Scale (CARS);The score of the Autism Behavior Rating Scale (ABC);The score of the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2);Adverse events;

Countries

China

Contacts

Public ContactYouran Li

Shanghai Children’s Hospital

liyr@shchildren.com.cn+86 135 6416 7695

Outcome results

None listed

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