Clinical trial
Washed Microbiota Transplantation (WMT) for Autism Spectrum Disorder (ASD)
Name
WMT-ASD-2023
Description
Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. 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 autism spectrum disorder; To study the potential etiological mechanism of autism spectrum disorder.
Trial arms
Trial start
2023-09-20
Estimated PCD
2026-04-04
Trial end
2026-05-01
Status
Recruiting
Phase
Early phase I
Treatment
Washed Microbiota Transplantation
The prepared microbiota suspension was infused into the participates' lower gut.
Arms:
Washed microbiota transplantation
Other names:
Fecal Microbiota Transplantation
Size
30
Primary endpoint
Changes in the Autism Behavior Checklist (ABC) in ASD children
baseline, 4 weeks , 8 weeks , 3 month, 6 months post transplantation
Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children
baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation
Eligibility criteria
Inclusion Criteria:
* Children who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and ADOS-2 diagnostic criteria.
* Age 3-14years.
Exclusion Criteria:
* ASD children with severe gastrointestinal symptoms or organic disease requiring immediate surgery or treatment.
* ASD children who have received antibiotics within 3 months, or are receiving immunosuppressive agents and biologics.
* ASD children with underlying diseases, such as severe anemia, malnutrition, autoimmune diseases (autoimmune thyroiditis, type I diabetes, etc.), allergic diseases (asthma, severe eczema, etc.), central nervous system diseases, metabolic syndrome, etc.
* ASD children with other organic dysfunctions, such as cerebral palsy, congenital genetic diseases, etc.; history of other psychiatric-behavioral disorders, genetic-metabolic diseases and other major physical diseases; other physical diseases, such as hearing impairment, vocal disorders, blindness, etc.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-04-29
1 organization