Washing gut bacteria to treat ADHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.