Washed Microbiota Transplantation to Treat ADHD Symptoms and Related Conditions in Children Aged 3 to 17

What this Trial Is About

Attention-deficithyperactivity disorder ADHD is a common neurodevelopmental condition marked by inattention and hyperactivity-impulsivity. It often coexists with oppositional defiant disorder and sleep disturbances, impacting academic and work performance, and increasing risks of other psychiatric issues. Researchers are examining the role of gut microbiota in ADHD through the gut-brain axis and aim to evaluate washed microbiota transplantation WMT for improving core ADHD symptoms and related conditions using specialized questionnaires. The study involves administering washed microbiota transplantation, where prepared microbiota suspension is infused into the participants lower gut. This approach is based on a new automated washing process to restore gut microbiota balance. The trial focuses on children aged 3 to 17 with ADHD who have had stable treatments for at least one month prior and have avoided antibiotics or probiotics for three months before WMT. Participants will be assessed using various questionnaires at baseline, 1 month, and 3 months after transplantation. These include measures for ADHD symptoms, sleep disturbances, gastrointestinal symptoms, and gut microbiome composition through fecal metagenome sequencing. The primary outcome is the Clinical Global Impressions-Improvement scale at 1 and 3 months. Safety and tolerability will also be monitored. Total participation spans several months, with evaluations to understand the mechanism and effectiveness of WMT for ADHD and its comorbidities.

Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder