xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06030752</url>
    </required_header>
    <id_info>
      <org_study_id>WMT-ASD-2023</org_study_id>
      <nct_id>NCT06030752</nct_id>
    </id_info>
    <brief_title>WMT for Autism Spectrum Disorder (ASD)</brief_title>
    <official_title>Washed Microbiota Transplantation (WMT) for Autism Spectrum Disorder (ASD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Second Hospital of Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>SIR RUN RUN hospital of Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The Second Hospital of Nanjing Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. Intestinal&#xD;
        microbial disturbance is common in children with ASD. A great deal of evidence shows that&#xD;
        intestinal microbes can influence the brain to play its role through &quot;gut-brain-microbiota&#xD;
        axis&quot;. We intend to explore the role of Washed Microbiota Transplantation in improving&#xD;
        symptoms of children in autism spectrum disorder; To study the potential etiological&#xD;
        mechanism of autism spectrum disorder.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Very few literatures reported the clinical use of microbiota or bacteria for Autism Spectrum&#xD;
        Disorder. The most effective strategy for reconstruction of gut microbiota should be fecal&#xD;
        microbiota transplantation (WMT). Washed microbiota transplantation (WMT) can significantly&#xD;
        reduce FMT-related AEs by removing parasite eggs, fecal particles, and fungi through a series&#xD;
        of automated washing procedures. This study aims to evaluate the efficacy and safety of FMT&#xD;
        for ASD. Patients received repeated WMT with fecal from healthy donors. Microbiota analysis&#xD;
        will also be performed on both the donor and recipient stool sample prior to transplantation,&#xD;
        and on the recipient sample at 3 month post transplantation. This study sought to evaluate&#xD;
        the efficacy of washed microbiota transplantation (WMT) in children with ASD and explore the&#xD;
        role of washed bacteria transplantation in improving ASD symptoms.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in the Autism Behavior Checklist (ABC) in ASD children</measure>
      <time_frame>baseline, 4 weeks , 8 weeks , 3 month, 6 months post transplantation</time_frame>
      <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&gt; 67 strongly suggests the presence of autism.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children</measure>
      <time_frame>baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome.</measure>
      <time_frame>Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental Global Impressions-Revised</measure>
      <time_frame>baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation</time_frame>
      <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.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>WMT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>WMT with microbiota suspension Participants undergo repeated FMT with ~50ml microbiota suspension.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Washed Microbiota Transplantation</intervention_name>
      <description>The prepared microbiota suspension was infused into the participates' lower gut.</description>
      <arm_group_label>WMT</arm_group_label>
      <other_name>Fecal Microbiota Transplantation</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition&#xD;
               (DSM-5) and ADOS-2 diagnostic criteria.&#xD;
  &#xD;
            -  Age 3-14years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ASD children with severe gastrointestinal symptoms or organic disease requiring&#xD;
               immediate surgery or treatment.&#xD;
  &#xD;
            -  ASD children who have received antibiotics within 3 months, or are receiving&#xD;
               immunosuppressive agents and biologics.&#xD;
  &#xD;
            -  ASD children with underlying diseases, such as severe anemia, malnutrition, autoimmune&#xD;
               diseases (autoimmune thyroiditis, type I diabetes, etc.), allergic diseases (asthma,&#xD;
               severe eczema, etc.), central nervous system diseases, metabolic syndrome, etc.&#xD;
  &#xD;
            -  ASD children with other organic dysfunctions, such as cerebral palsy, congenital&#xD;
               genetic diseases, etc.; history of other psychiatric-behavioral disorders,&#xD;
               genetic-metabolic diseases and other major physical diseases; other physical diseases,&#xD;
               such as hearing impairment, vocal disorders, blindness, etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>May 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>fecal Microbiota Transplantation</keyword>
    <keyword>Autism spectrum disorder</keyword>
    <keyword>Gut microbiota</keyword>
    <keyword>Gut-brain axis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
      <mesh_term>Child Development Disorders, Pervasive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06030752
  org study id: WMT-ASD-2023
  nct id: NCT06030752
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Changes in the Autism Behavior Checklist (ABC) in ASD children
  time frame: baseline, 4 weeks , 8 weeks , 3 month, 6 months post transplantation
  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.
  measure: Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children
  time frame: baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation
  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.
  measure: Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome.
  time frame: Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.
  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.
  measure: Parental Global Impressions-Revised
  time frame: baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation
  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.
  arm group label: WMT
  arm group type: Experimental
  description: WMT with microbiota suspension Participants undergo repeated FMT with ~50ml microbiota suspension.
  intervention type: Drug
  intervention name: Washed Microbiota Transplantation
  description: The prepared microbiota suspension was infused into the participates' lower gut.
  arm group label: WMT
  other name: Fecal Microbiota Transplantation
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 14 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive
  sharing ipd: Yes