WMT for Autism Spectrum Disorder (ASD)
Recruiting now · Phase 1
Conditions studied: Autism Spectrum Disorder
In brief
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-thirds with ADHD show ASD traits. Intestinal microbial disturbance is common in children with ASD. A great deal of evidence shows that intestinal microbes can influence the brain to play its role through "gut-brain-microbiota axis". We intend to explore the role of Washed Microbiota Transplantation in improving symptoms of children in ASD with or without ADHD; To study the potential etiological mechanism of WMT for the neurodevelopmental disorders.
Key facts
- Study ID
- NCT06030752
- Run by
- The Second Hospital of Nanjing Medical University
- People needed
- 80
- Starts
- 2023-09-20
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2025-09-05
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
- SIR RUN RUN hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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