Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder
Recruiting now · Phase 1
Conditions studied: Attention-deficit/Hyperactivity Disorder
In brief
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.
Key facts
- Study ID
- NCT06376331
- Run by
- The Second Hospital of Nanjing Medical University
- People needed
- 50
- Starts
- 2024-04-28
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2025-09-05
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- 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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