Using washed microbiota transplantation to treat autism spectrum disorder
Official title: Washed Microbiota Transplantation (WMT) for Autism Spectrum Disorder (ASD)
Run by The Second Hospital of Nanjing Medical University · NCT06030752 · Data updated 2026-11-12
This study is testing whether a new treatment using healthy gut bacteria can help improve symptoms in children with Autism Spectrum Disorder.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 17 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Status | Recruiting |
| Started | September 20, 2023 |
| Main results expected | April 4, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT06030752 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 14 years who meet the DSM-5 diagnostic criteria for autism spectrum disorder.
✕Probably not a fit
Patients with severe comorbidities, gastrointestinal diseases, or those who have used antibiotics or probiotics in the last three months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study explores the use of washed microbiota transplantation (WMT) to improve symptoms in children diagnosed with Autism Spectrum Disorder (ASD). It focuses on the gut-brain-microbiota axis, investigating how intestinal microbes can influence brain function. Participants aged 3 to 14 years who meet specific diagnostic criteria will receive repeated WMT from healthy donors, with microbiota analysis conducted before and after the procedure. The study aims to evaluate both the efficacy and safety of this innovative approach in treating ASD symptoms.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option that improves symptoms of autism spectrum disorder in children.
How similar studies have gone: While few studies have explored microbiota transplantation for ASD, this approach is relatively novel and has not been widely tested in clinical settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children and adolescents with an established diagnosis of ASD or ADHD + ASD according to the Diagnostic and Statistical Manual Of Mental Disorders Fifth Edition;. * Age 3-17 years. * Received stable treatments for ≥1 month preceding WMT Exclusion Criteria: * Their guardian could not understand the questionnaires or provide informed consent. * Diagnosed with a single-gene disorder, major brain malformations, gastrointestinal diseases (ulcerative colitis, Crohn's disease, or eosinophilic esophagitis) * Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases, severe infection, tumors, etc. * Accompanied with other life-threatening disorders required emergency treatment. * 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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.