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RECRUITINGPhase 1INTERVENTIONAL

Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Children with an established diagnosis of ADHD according to Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition; 2. Aged 3-17; 3. Received stable treatments for ≥1 month preceding WMT; 4. Did not take medications affecting gut microbiota such as antibiotics and probiotics three months before WMT. Who Should NOT Join This Trial: 1. Unable to understand the questionnaires or provide willing to sign a consent form by the guardian; 2. Diagnosed with a single-gene disorder, psychosis, central nervous system diseases, gastrointestinal diseases including ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis; 3. Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases and cancer; 4. Accompanied with other life-threatening disorders required emergency treatment; 5. Unable to tolerate colonoscopy or anesthesia Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Children with an established diagnosis of ADHD according to Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition; 2. Aged 3-17; 3. Received stable treatments for ≥1 month preceding WMT; 4. Did not take medications affecting gut microbiota such as antibiotics and probiotics three months before WMT. Exclusion Criteria: 1. Unable to understand the questionnaires or provide informed consent by the guardian; 2. Diagnosed with a single-gene disorder, psychosis, central nervous system diseases, gastrointestinal diseases including ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis; 3. Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases and cancer; 4. Accompanied with other life-threatening disorders required emergency treatment; 5. Unable to tolerate colonoscopy or anesthesia

Treatments Being Tested

DRUG

washed 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