WMT for Autism Spectrum Disorder (ASD)
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 evid
| Condition(s) | Autism Spectrum Disorder |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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-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. |
| Who can participate | Inclusion Criteria: * 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 Criteria: * 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. |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Lead sponsor | The Second Hospital of Nanjing Medical University |
| Locations | Nanjing, Jiangsu, China; Nanjing, Jiangsu, China |
| Start date | 2023-09-20 |
| NCT ID | NCT06030752 |
| Official listing | https://clinicaltrials.gov/study/NCT06030752 |