Attention-deficit/hyperactivity disorder.
Stephen V Faraone, Mark A Bellgrove, Isabell Brikell...
https://pubmed.ncbi.nlm.nih.gov/38388701Actively Recruiting
Phase 1
Age: 3Years - 17Years
All Genders
Healthy Volunteers
ID06376331
Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder and Its Comorbidities
Led by The Second Hospital of Nanjing Medical University · Updated on 2025-09-05
50
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
T
The Second Hospital of Nanjing Medical University
Lead Sponsor
N
Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition marked by inattention and hyperactivity-impulsivity. It often coexists with oppositional defiant disorder and sleep disturbances, impacting academic and work performance, and increasing risks of other psychiatric issues. Researchers are examining the role of gut microbiota in ADHD through the gut-brain axis and aim to evaluate washed microbiota transplantation (WMT) for improving core ADHD symptoms and related conditions using specialized questionnaires. The study involves administering washed microbiota transplantation, where prepared microbiota suspension is infused into the participant's lower gut. This approach is based on a new automated washing process to restore gut microbiota balance. The trial focuses on children aged 3 to 17 with ADHD who have had stable treatments for at least one month prior and have avoided antibiotics or probiotics for three months before WMT. Participants will be assessed using various questionnaires at baseline, 1 month, and 3 months after transplantation. These include measures for ADHD symptoms, sleep disturbances, gastrointestinal symptoms, and gut microbiome composition through fecal metagenome sequencing. The primary outcome is the Clinical Global Impressions-Improvement scale at 1 and 3 months. Safety and tolerability will also be monitored. Total participation spans several months, with evaluations to understand the mechanism and effectiveness of WMT for ADHD and its comorbidities.
CONDITIONS
Brief Title
Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder
Who Can Participate
Age: 3Years - 17Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Children diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
- Aged 3 to 17 years
- Have received stable treatments for at least 1 month before washed microbiota transplantation
- Have not taken medications affecting gut microbiota, such as antibiotics or probiotics, for 3 months before transplantation
You will not qualify if you...
- Unable to understand questionnaires or provide informed consent by guardian
- Diagnosed with single-gene disorders, psychosis, central nervous system diseases, or gastrointestinal diseases like ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis
- Have severe comorbidities including cardiopulmonary failure, severe liver or kidney diseases, or cancer
- Have life-threatening disorders requiring emergency treatment
- Unable to tolerate colonoscopy or anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single administration with follow-up assessments up to 3 months
Participants receive washed microbiota transplantation, where a prepared microbiota suspension is infused into the lower gut to treat ADHD symptoms.
1 treatment visit and 2 follow-up visits at 1 month and 3 months post transplantation
Trial Site Locations
Total: 2 locations
1
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
2
SIR RUN RUN hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
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Research Team
F
Faming Zhang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Impulsivity as key bridge symptoms in cross-sectional and longitudinal networks of ADHD and ODD.
Pevitr S Bansal, Patrick K Goh, Matthew W Southward...
https://pubmed.ncbi.nlm.nih.gov/37474723Objectively measured sleep continuity in children and adolescents with ADHD: A systematic review and meta-analysis.
Xiao Liang, Hui Qiu, Shirley Xin Li
https://pubmed.ncbi.nlm.nih.gov/37657199Anxiety, mood, and substance use disorders in adult men and women with and without attention-deficit/hyperactivity disorder: A substantive and methodological overview.
Catharina A Hartman, Henrik Larsson, Melissa Vos...
https://pubmed.ncbi.nlm.nih.gov/37149075The microbiota-gut-brain axis and neurodevelopmental disorders.
Qinwen Wang, Qianyue Yang, Xingyin Liu
https://pubmed.ncbi.nlm.nih.gov/37166201Gut microbiota from persons with attention-deficit/hyperactivity disorder affects the brain in mice.
Anouk C Tengeler, Sarita A Dam, Maximilian Wiesmann...
https://pubmed.ncbi.nlm.nih.gov/32238191Assessment of probiotic strain Lactobacillus acidophilus LB supplementation as adjunctive management of attention-deficit hyperactivity disorder in children and adolescents: a randomized controlled clinical trial.
Reham M Elhossiny, Heba H Elshahawy, Hanan M Mohamed...
https://pubmed.ncbi.nlm.nih.gov/37946220Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening.
Ting Zhang, Gaochen Lu, Zhe Zhao...
https://pubmed.ncbi.nlm.nih.gov/31919742Nanjing consensus on methodology of washed microbiota transplantation.
https://pubmed.ncbi.nlm.nih.gov/32701590Parent and teacher SNAP-IV ratings of attention deficit hyperactivity disorder symptoms: psychometric properties and normative ratings from a school district sample.
Regina Bussing, Melanie Fernandez, Michelle Harwood...
https://pubmed.ncbi.nlm.nih.gov/18310593