Washed Microbiota Transplantation: The prepared microbiota suspension was infused into the participates' lower gut.
Study 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
Sex
ALL
Min age
3 Years
Max age
17 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Changes in the Autism Behavior Checklist (ABC) in ASD children — baseline, 1 month , 3 months, 6 months post transplantation ABC is a scale used for nonadaptive behaviors created to screen and indicate the probability of a diagnosis of autism. The questionnaire including 57 items related to five areas: sensorial, relational, use of body and objects, and social skills. Scale score\> 67 strongly suggests the presence of autism.
Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children — baseline, 1 month,3 months, 6 months post transplantation ASD symptoms will be assessed using the Chinese version of the Autism Treatment Evaluation Checklist (ATEC), which comprise four subscales to measure child speech/language/communication, sociability, sensory/cognitive awareness, and health/physical/behavior. The scale has 77 items that are scored by parents. The health/physical/behavior subscale is rated using a 0 (not a problem)-to-3 (serious problem) point scale, whereas the other three subscales are rated using a 0 (not true)-to-2 (very true) point scale. Higher scores represent more ASD symptoms.
Trial sites (2)
Facility
City
Region
Status
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
Recruiting
SIR RUN RUN hospital of Nanjing Medical University
Nanjing
Jiangsu
Recruiting
More The Second Hospital of Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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