RecruitingPhase 1NCT06376331

Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder

Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder and Its Comorbidities


Sponsor

The Second Hospital of Nanjing Medical University

Enrollment

50 participants

Start Date

Apr 28, 2024

Study Type

INTERVENTIONAL

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

Min Age: 3 YearsMax Age: 17 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

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Interventions

DRUGwashed microbiota transplantation

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


Locations(2)

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

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NCT06376331