Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-17
SponsorThe Second Hospital of Nanjing Medical University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- washed microbiota transplantation
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
The Second Hospital of Nanjing Medical University
Lead sponsor
Nanjing Medical University
Collaborator
Source ClinicalTrials.gov