WMT for Autism Spectrum Disorder (ASD)
ConditionAutism Spectrum Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-17
SponsorThe Second Hospital of Nanjing Medical University
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Washed Microbiota Transplantation
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
The Second Hospital of Nanjing Medical University
Lead sponsor
Nanjing Medical University
Collaborator
Source ClinicalTrials.gov