WMT for Autism Spectrum Disorder (ASD)

Study Overview
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Brief Summary
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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.

Detailed Description
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Very few literatures reported the clinical use of microbiota or bacteria for Autism Spectrum Disorder. The most effective strategy for reconstruction of gut microbiota should be fecal microbiota transplantation (WMT). Washed microbiota transplantation (WMT) can significantly reduce FMT-related AEs by removing parasite eggs, fecal particles, and fungi through a series of automated washing procedures. This study aims to evaluate the efficacy and safety of FMT for ASD. Patients received repeated WMT with fecal from healthy donors. Microbiota analysis will also be performed on both the donor and recipient stool sample prior to transplantation, and on the recipient sample at 3 month post transplantation. This study sought to evaluate the efficacy of washed microbiota transplantation (WMT) in children with ASD and explore the role of washed bacteria transplantation in improving ASD symptoms.

Official Title
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Washed Microbiota Transplantation (WMT) for Autism Spectrum Disorder (ASD)

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: Washed Microbiota Transplantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WMT<br>WMT with microbiota suspension Participants undergo repeated FMT with  50ml microbiota suspension. | Drug: Washed Microbiota Transplantation<br>* The prepared microbiota suspension was infused into the participates' lower gut.<br>* Other names: Fecal Microbiota Transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Autism Behavior Checklist (ABC) in ASD children | 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. | baseline, 4 weeks , 8 weeks , 3 month, 6 months post transplantation | 
| Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children | 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. | baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome. | The composition of the gut microbe was evaluated by sequencing faecal metagenome. We evaluate the differences in the structure of the flora and its metabolism between the two at the phylum, genus and species levels of the intestinal flora and control children, and to develop a model for predicting the structure of the flora. | Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation. | 
| Parental Global Impressions-Revised | The PGI-R is a rating of change of 18 autism symptoms compared to baseline, with each symptom rated on a Likert scale from -3 (much worse) to zero (no change) to +3 (much better). We report the average change of the 18 symptoms, so the possible range is from -3 to +3. | baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal Microbiota Transplantation, Autism spectrum disorder, Gut microbiota, Gut-brain axis