Back to resultsWMT for Autism Spectrum Disorder (ASD)
Primary Purpose
Autism Spectrum Disorder
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Washed Microbiota Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring fecal Microbiota Transplantation, Autism spectrum disorder, Gut microbiota, Gut-brain axis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WMT
Arm Description
WMT with microbiota suspension Participants undergo repeated FMT with ~50ml microbiota suspension.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT06030752
First Posted
May 25, 2023
Last Updated
September 7, 2023
Sponsor
The Second Hospital of Nanjing Medical University
Collaborators
SIR RUN RUN hospital of Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT06030752
Brief Title
WMT for Autism Spectrum Disorder (ASD)
Official Title
Washed Microbiota Transplantation (WMT) for Autism Spectrum Disorder (ASD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 20, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Nanjing Medical University
Collaborators
SIR RUN RUN hospital of Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
fecal Microbiota Transplantation, Autism spectrum disorder, Gut microbiota, Gut-brain axis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WMT
Arm Type
Experimental
Arm Description
WMT with microbiota suspension Participants undergo repeated FMT with ~50ml microbiota suspension.
Intervention Type
Drug
Intervention Name(s)
Washed Microbiota Transplantation
Other Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
The prepared microbiota suspension was infused into the participates' lower gut.
Primary Outcome Measure Information:
Title
Changes in the Autism Behavior Checklist (ABC) in ASD children
Description
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.
Time Frame
baseline, 4 weeks , 8 weeks , 3 month, 6 months post transplantation
Title
Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children
Description
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.
Time Frame
baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation
Secondary Outcome Measure Information:
Title
Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome.
Description
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.
Time Frame
Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.
Title
Parental Global Impressions-Revised
Description
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.
Time Frame
baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
WMT for Autism Spectrum Disorder (ASD)
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