Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

washed microbiota transplantation: The prepared microbiota suspension was infused into the participates' lower gut.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Clinical Global Impressions-Improvement (CGI-I) — 1 month, 3 months post transplantation
  The Clinical Global Impressions-Improvement (CGI-I) evaluated by experienced clinician was used to assess the symptom changes relative to baseline, rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). CGI-I = 1 or 2 was considered a clinical response.

Trial sites (2)

More The Second Hospital of Nanjing Medical University trials in China