Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder
Recruiting · NCT06376331 · Observational (researchers observe without assigning treatment) · Lead sponsor: The Second Hospital of Nanjing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention and hyperactivity-impulsivity. ADHD is often accompanied by oppositional defiant disorder and sleep disturbance, and can increase the risk of other psychiatric disorders, functional impairment in academic and occupational performance. Recently, gut microbiota has been implicated in the ADHD via gut-brain axis. In this study, investigators aimed to evaluate the efficacy of WMT for core ADHD symptoms and its comorbidities using specialized questionnaires for ADHD and investigate the underlying mechanism.
Who can take part
Inclusion criteria
- Children with an established diagnosis of ADHD according to Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition;
- Aged 3-17;
- Received stable treatments for ≥1 month preceding WMT;
- Did not take medications affecting gut microbiota such as antibiotics and probiotics three months before WMT.
Exclusion criteria
- Unable to understand the questionnaires or provide informed consent by the guardian;
- Diagnosed with a single-gene disorder, psychosis, central nervous system diseases, gastrointestinal diseases including ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis;
- Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases and cancer;
- Accompanied with other life-threatening disorders required emergency treatment;
- Unable to tolerate colonoscopy or anesthesia
Where it is running
2 locations listed.
- Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University - Nanjing, Jiangsu, China
- SIR RUN RUN hospital of Nanjing Medical University - Nanjing, Jiangsu, China