Status:
RECRUITING
WMT for Autism Spectrum Disorder (ASD)
Lead Sponsor:
The Second Hospital of Nanjing Medical University
Collaborating Sponsors:
Nanjing Medical University
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-17 years
Phase:
PHASE1
Brief Summary
Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. A significant comorbidity exists between ADHD and ASD: 30%-50% of individuals with ASD exhibit ADHD symptoms, and two...
Detailed Description
Very few literatures reported the clinical use of microbiota or bacteria for Autism Spectrum Disorder. The most effective strategy for reconstruction of gut microbiota should be fecal microbiota trans...
Eligibility Criteria
Inclusion
- Children and adolescents with an established diagnosis of ADHD or ADHD + ASD according to the Diagnostic and Statistical Manual Of Mental Disorders Fifth Edition;.
- Age 3-17 years.
- Received stable treatments for ≥1 month preceding WMT
Exclusion
- Their guardian could not understand the questionnaires or provide informed consent.
- Diagnosed with a single-gene disorder, major brain malformations, gastrointestinal diseases (ulcerative colitis, Crohn's disease, or eosinophilic esophagitis)
- Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases, severe infection, tumors, etc.
- Accompanied with other life-threatening disorders required emergency treatment.
- Unable to tolerate colonoscopy or anesthesia.
Key Trial Info
Start Date :
September 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06030752
Start Date
September 20 2023
End Date
May 1 2027
Last Update
September 5 2025
Active Locations (2)
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1
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
2
SIR RUN RUN hospital of Nanjing Medical University
Nanjing, Jiangsu, China