NCT06030752 WMT for Autism Spectrum Disorder (ASD)
| NCT ID | NCT06030752 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The Second Hospital of Nanjing Medical University |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-09-20 |
| Primary Completion | 2027-04-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2023-09-20 with a primary completion date of 2027-04-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. A significant comorbidity exists between ADHD and ASD: 30%-50% of individuals with ASD exhibit ADHD symptoms, and two-thirds with ADHD show ASD traits. Intestinal microbial disturbance is common in children with ASD. A great deal of evidence shows that intestinal microbes can influence the brain to play its role through "gut-brain-microbiota axis". We intend to explore the role of Washed Microbiota Transplantation in improving symptoms of children in ASD with or without ADHD; To study the potential etiological mechanism of WMT for the neurodevelopmental disorders.
Eligibility Criteria
Inclusion Criteria: * Children and adolescents with an established diagnosis of ADHD 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.
Contact & Investigator
Faming Zhang, PhD
PRINCIPAL INVESTIGATOR
The Second Hospital of Nanjing Medical University
Frequently Asked Questions
Who can join the NCT06030752 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06030752 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06030752 currently recruiting?
Yes, NCT06030752 is actively recruiting participants. Contact the research team at fzhang@njmu.edu.cn for enrollment information.
Where is the NCT06030752 trial being conducted?
This trial is being conducted at Nanjing, China, Nanjing, China.
Who is sponsoring the NCT06030752 clinical trial?
NCT06030752 is sponsored by The Second Hospital of Nanjing Medical University. The principal investigator is Faming Zhang, PhD at The Second Hospital of Nanjing Medical University. The trial plans to enroll 80 participants.