<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/NCT03764748</url>
  </required_header>
  <id_info>
    <org_study_id>SMT-YJ-201701</org_study_id>
    <nct_id>NCT03764748</nct_id>
  </id_info>
  <brief_title>Selective Microbiota Transplantation for Tourette's Syndrome</brief_title>
  <acronym>mini-FMT</acronym>
  <official_title>Efficacy and Safety of Selective Microbiota Transplantation for Tourette's Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faming Zhang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Hospital of Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to evaluate the role of selective microbiota transplantation on Tourette's&#xD;
      syndrome (TS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emerging scientific data support the significant role of microbiota in the modulation of the&#xD;
      central nervous system. The reconstitution of gut microbiota might be a potential option to&#xD;
      treat Tourette's syndrome (TS). This study aims to evaluate the role of selective microbiota&#xD;
      transplantation on Tourette's syndrome (TS). Patients aged 7 to 60 years old with TS and a&#xD;
      Yale Global Tic Severity Scale (YGTSS) -total tic score ≥20 will be enrolled in this&#xD;
      open-label clinical trial. Participants will receive 200ml selective microbiota suspension&#xD;
      (namely mini-FMT, mixed species of cultured bacteria) daily through the nasojejunal&#xD;
      transendoscopic enteral tubing (TET) tube for 3 days. Clinical evaluations before, 1, 4 and 8&#xD;
      weeks after mini-FMT will be assessed with the YGTSS, the Gilles de la Tourette Syndrome&#xD;
      Quality-of-Life Scale (GTS-QOL), the Clinical Global Impression (CGI)-Severity, the&#xD;
      Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the Beck Depression Inventory (BDI) and the&#xD;
      Beck Anxiety Inventory (BAI). 16S rRNA stool analysis will be performed to assess associated&#xD;
      microbial changes. The urinary metabolic profiles of those patients will be generated using&#xD;
      nuclear magnetic resonance (NMR) spectroscopy. Safety will be assessed in all patients after&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 17, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <intervention_model_description>Participants will receive 200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of Yale Global Tic Severity Scale total score</measure>
    <time_frame>8 weeks</time_frame>
    <description>The change of tic severity according to the Yale Global Tic Severity Scale total score at 8 weeks after treatment. Yale Global Tic Severity Scale total score ranges 0-100, and higher values represent a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the Clinical Global Impressions-Improvement scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>Positive treatment response was defined by a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impressions-Improvement scale. The Clinical Global Impression - Improvement scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:1.Very much improved; 2.Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; 7.Very much worse. The Clinical Global Impressions-Improvement scale score will recorded at week 8 after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change of Clinical Global Impression-Severity</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Clinical Global Impression-Severity scale is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1.Normal, not at all; 2.Borderline mentally; 3. Mildly; 4.Moderately; 5. Markedly; 6. Severely; 7. Among the most extremely. The change of Clinical Global Impression-Severity will be recorded at week 8 after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change of Gilles de la Tourette Syndrome Quality-of-Life Scale score</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Gilles de la Tourette Syndrome Quality-of-Life Scale addresses the issue of how the illness affects patients' well-being. It ranges from 0 to108, and higher values represent a worse outcome. The change of life quality according to the Gilles de la Tourette Syndrome Quality-of-Life Scale score at 1 week, 2 weeks and 8 weeks after treatment.The change of Gilles de la Tourette Syndrome Quality-of-Life Scale score will be recorded at week 8 after treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Tourette Syndrome</condition>
  <arm_group>
    <arm_group_label>mini-FMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mini-FMT</intervention_name>
    <description>200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) will be delivered daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days.</description>
    <arm_group_label>mini-FMT</arm_group_label>
    <other_name>Selective microbiota transplantation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  7-60 years old with Tourette or chronic tic disorder of moderate or greater severity&#xD;
             as measured by a Yale Global Tic Severity Scale-Total score&gt;25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complicated with certain brain disease, including tumor,injury,cerebrovascular&#xD;
             disease;&#xD;
&#xD;
          -  Complicated with other severe disease, including cancers, organ failure, heart&#xD;
             diseases;&#xD;
&#xD;
          -  Follow-up less than 8 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faming Zhang, MD; PHD</last_name>
    <role>Study Chair</role>
    <affiliation>The Second Hospital of Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Faming Zhang, MD; PHD</last_name>
    <phone>025-58509883</phone>
    <email>fzhang@njmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiao Ding, MD</last_name>
    <phone>86-15250963899</phone>
    <email>xding@njmu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fmt-Dt-N-27/1350</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Faming Zhang, PhD,MD</last_name>
      <phone>86-025-58509883</phone>
      <email>fzhang@njmu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Faming Zhang, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Faming Zhang, MD, PhD</last_name>
      <phone>086-25-58509883</phone>
      <email>fzhang@njmu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Hoffman BU, Lumpkin EA. A gut feeling. Science. 2018 Sep 21;361(6408):1203-1204. doi: 10.1126/science.aau9973. No abstract available.</citation>
    <PMID>30237346</PMID>
  </reference>
  <reference>
    <citation>Foster JA. Targeting the Microbiome for Mental Health: Hype or Hope? Biol Psychiatry. 2017 Oct 1;82(7):456-457. doi: 10.1016/j.biopsych.2017.08.002. No abstract available.</citation>
    <PMID>28870296</PMID>
  </reference>
  <reference>
    <citation>Roessner V, Plessen KJ, Rothenberger A, Ludolph AG, Rizzo R, Skov L, Strand G, Stern JS, Termine C, Hoekstra PJ; ESSTS Guidelines Group. European clinical guidelines for Tourette syndrome and other tic disorders. Part II: pharmacological treatment. Eur Child Adolesc Psychiatry. 2011 Apr;20(4):173-96. doi: 10.1007/s00787-011-0163-7. Erratum In: Eur Child Adolesc Psychiatry. 2011 Jul;20(7):377.</citation>
    <PMID>21445724</PMID>
  </reference>
  <reference>
    <citation>Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.</citation>
    <PMID>27556065</PMID>
  </reference>
  <reference>
    <citation>Zhang F, Cui B, He X, Nie Y, Wu K, Fan D; FMT-standardization Study Group. Microbiota transplantation: concept, methodology and strategy for its modernization. Protein Cell. 2018 May;9(5):462-473. doi: 10.1007/s13238-018-0541-8. Epub 2018 Apr 24.</citation>
    <PMID>29691757</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>September 21, 2019</last_update_submitted>
  <last_update_submitted_qc>September 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Second Hospital of Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Faming Zhang</investigator_full_name>
    <investigator_title>Associate professor, Gastroenterology</investigator_title>
  </responsible_party>
  <keyword>Tic Disorders</keyword>
  <keyword>Gut microbiota</keyword>
  <keyword>Brain-gut axis</keyword>
  <keyword>Microbiota Transplantation</keyword>
  <keyword>Tourette syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tourette Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03764748
org study id: SMT-YJ-201701
nct id: NCT03764748
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aimed to evaluate the role of selective microbiota transplantation on Tourette's
      syndrome (TS).
Emerging scientific data support the significant role of microbiota in the modulation of the
      central nervous system. The reconstitution of gut microbiota might be a potential option to
      treat Tourette's syndrome (TS). This study aims to evaluate the role of selective microbiota
      transplantation on Tourette's syndrome (TS). Patients aged 7 to 60 years old with TS and a
      Yale Global Tic Severity Scale (YGTSS) -total tic score ≥20 will be enrolled in this
      open-label clinical trial. Participants will receive 200ml selective microbiota suspension
      (namely mini-FMT, mixed species of cultured bacteria) daily through the nasojejunal
      transendoscopic enteral tubing (TET) tube for 3 days. Clinical evaluations before, 1, 4 and 8
      weeks after mini-FMT will be assessed with the YGTSS, the Gilles de la Tourette Syndrome
      Quality-of-Life Scale (GTS-QOL), the Clinical Global Impression (CGI)-Severity, the
      Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the Beck Depression Inventory (BDI) and the
      Beck Anxiety Inventory (BAI). 16S rRNA stool analysis will be performed to assess associated
      microbial changes. The urinary metabolic profiles of those patients will be generated using
      nuclear magnetic resonance (NMR) spectroscopy. Safety will be assessed in all patients after
      treatment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants will receive 200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days.
primary purpose: Treatment
masking: None (Open Label)
measure: The change of Yale Global Tic Severity Scale total score
time frame: 8 weeks
description: The change of tic severity according to the Yale Global Tic Severity Scale total score at 8 weeks after treatment. Yale Global Tic Severity Scale total score ranges 0-100, and higher values represent a worse outcome.
measure: the Clinical Global Impressions-Improvement scale
time frame: 8 weeks
description: Positive treatment response was defined by a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impressions-Improvement scale. The Clinical Global Impression - Improvement scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:1.Very much improved; 2.Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; 7.Very much worse. The Clinical Global Impressions-Improvement scale score will recorded at week 8 after treatment.
measure: the change of Clinical Global Impression-Severity
time frame: 8 weeks
description: The Clinical Global Impression-Severity scale is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1.Normal, not at all; 2.Borderline mentally; 3. Mildly; 4.Moderately; 5. Markedly; 6. Severely; 7. Among the most extremely. The change of Clinical Global Impression-Severity will be recorded at week 8 after treatment.
measure: the change of Gilles de la Tourette Syndrome Quality-of-Life Scale score
time frame: 8 weeks
description: The Gilles de la Tourette Syndrome Quality-of-Life Scale addresses the issue of how the illness affects patients' well-being. It ranges from 0 to108, and higher values represent a worse outcome. The change of life quality according to the Gilles de la Tourette Syndrome Quality-of-Life Scale score at 1 week, 2 weeks and 8 weeks after treatment.The change of Gilles de la Tourette Syndrome Quality-of-Life Scale score will be recorded at week 8 after treatment.
arm group label: mini-FMT
arm group type: Experimental
description: Participants will receive 200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days.
intervention type: Drug
intervention name: mini-FMT
description: 200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) will be delivered daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days.
arm group label: mini-FMT
other name: Selective microbiota transplantation
criteria: 
gender: All
minimum age: 7 Years
maximum age: 60 Years
healthy volunteers: No
last name: Faming Zhang, MD; PHD
role: Study Chair
affiliation: The Second Hospital of Nanjing Medical University
last name: Faming Zhang, MD; PHD
phone: 025-58509883
email: fzhang@njmu.edu.cn
last name: Xiao Ding, MD
phone: 86-15250963899
email: xding@njmu.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: China
citation: Hoffman BU, Lumpkin EA. A gut feeling. Science. 2018 Sep 21;361(6408):1203-1204. doi: 10.1126/science.aau9973. No abstract available.
PMID: 30237346
citation: Foster JA. Targeting the Microbiome for Mental Health: Hype or Hope? Biol Psychiatry. 2017 Oct 1;82(7):456-457. doi: 10.1016/j.biopsych.2017.08.002. No abstract available.
PMID: 28870296
citation: Roessner V, Plessen KJ, Rothenberger A, Ludolph AG, Rizzo R, Skov L, Strand G, Stern JS, Termine C, Hoekstra PJ; ESSTS Guidelines Group. European clinical guidelines for Tourette syndrome and other tic disorders. Part II: pharmacological treatment. Eur Child Adolesc Psychiatry. 2011 Apr;20(4):173-96. doi: 10.1007/s00787-011-0163-7. Erratum In: Eur Child Adolesc Psychiatry. 2011 Jul;20(7):377.
PMID: 21445724
citation: Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.
PMID: 27556065
citation: Zhang F, Cui B, He X, Nie Y, Wu K, Fan D; FMT-standardization Study Group. Microbiota transplantation: concept, methodology and strategy for its modernization. Protein Cell. 2018 May;9(5):462-473. doi: 10.1007/s13238-018-0541-8. Epub 2018 Apr 24.
PMID: 29691757
responsible party type: Sponsor-Investigator
investigator affiliation: The Second Hospital of Nanjing Medical University
investigator full name: Faming Zhang
investigator title: Associate professor, Gastroenterology
mesh term: Tourette Syndrome
mesh term: Syndrome