Washing gut bacteria to treat ADHD
Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder and Its Comorbidities
This study is testing if a special treatment that cleans gut bacteria can help children with ADHD feel better and improve their symptoms.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT06376331 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of washed microbiota transplantation (WMT) in treating core symptoms of attention-deficit/hyperactivity disorder (ADHD) and its associated comorbidities. By utilizing a specialized washing process to prepare gut microbiota from healthy donors, the study aims to restore gut microbiota balance in children diagnosed with ADHD. Participants aged 5-17 will undergo WMT while their ADHD symptoms will be assessed using specific questionnaires. The study also seeks to explore the underlying mechanisms of how gut microbiota influences ADHD symptoms through the gut-brain axis.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5-17 with a confirmed diagnosis of ADHD who have stable treatment regimens and have not taken medications affecting gut microbiota recently.
Not a fit: Patients with severe comorbidities, gastrointestinal diseases, or those who have previously undergone fecal microbiota transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for children with ADHD, potentially improving their symptoms and overall quality of life.
How similar studies have performed: While there has been limited research on the use of microbiota transplantation for ADHD, some studies have shown potential benefits in related conditions, indicating a promising but largely unexplored area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanjing, Jiangsu and 1 other locations
- Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
- SIR RUN RUN hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Faming Zhang, PhD — The Second Hospital of Nanjing Medical University
- Study coordinator: Faming Zhang, PhD
- Email: fzhang@njmu.edu.cn
- Phone: 086-25-58509883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.