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/NCT05990972</url>
    </required_header>
    <id_info>
      <org_study_id>FMT-AAD</org_study_id>
      <nct_id>NCT05990972</nct_id>
    </id_info>
    <brief_title>Clinical Study of Fecal Microbiota Transplantation in the Treatment of Antibiotic-associated Diarrhea</brief_title>
    <official_title>To Investigate the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Antibiotic-associated Diarrhea.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai 10th People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai 10th People's Hospital</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>
        Antibiotic-associated diarrhea (AAD) refers to the occurrence of other unexplained diarrhea&#xD;
        symptoms after the use of antibiotics, often combined with abdominal pain, bloating and&#xD;
        bloody stool. Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant&#xD;
        the microbiota from the feces of healthy people into the intestinal tract of patients. To&#xD;
        explore the overall efficacy and safety of FMT in the treatment of AAD.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 20, 2020</start_date>
    <completion_date type="Actual">July 20, 2023</completion_date>
    <primary_completion_date type="Actual">April 20, 2023</primary_completion_date>
    <phase>N/A</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 defecation frequency after FMT.</measure>
      <time_frame>Baseline and three months after treatment</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in gut microbiota after FMT.</measure>
      <time_frame>Baseline and three months after treatment.</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">25</enrollment>
    <condition>Fecal Microbiota Transplantation</condition>
    <condition>Antibiotic-associated Diarrhea</condition>
    <arm_group>
      <arm_group_label>FMT group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Fecal Microbiota Transplantation</intervention_name>
      <description>Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. This treatment aims to improve a range of diseases associated with the gut microbiota by restoring the balance of the gut microbiota.</description>
      <arm_group_label>FMT group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  occurrence of antibiotic-associated diarrhoea; no response to standard therapy; agree&#xD;
               to receive FMT and sign informed consent; willingness to provide stool samples.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  non-antibiotic-associated diarrhea; did not accept FMT or did not sign informed&#xD;
               consent; unwillingness to provide stool samples.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>78 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Le Wang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai 10th People's Hospital</investigator_affiliation>
      <investigator_full_name>Huanlong Qin</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diarrhea</mesh_term>
    </condition_browse>
    <!-- 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/NCT05990972
  org study id: FMT-AAD
  nct id: NCT05990972
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Antibiotic-associated diarrhea (AAD) refers to the occurrence of other unexplained diarrhea
        symptoms after the use of antibiotics, often combined with abdominal pain, bloating and
        bloody stool. Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant
        the microbiota from the feces of healthy people into the intestinal tract of patients. To
        explore the overall efficacy and safety of FMT in the treatment of AAD.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Changes in defecation frequency after FMT.
  time frame: Baseline and three months after treatment
  measure: Changes in gut microbiota after FMT.
  time frame: Baseline and three months after treatment.
  arm group label: FMT group
  arm group type: Experimental
  intervention type: Procedure
  intervention name: Fecal Microbiota Transplantation
  description: Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. This treatment aims to improve a range of diseases associated with the gut microbiota by restoring the balance of the gut microbiota.
  arm group label: FMT group
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 78 Years
  healthy volunteers: No
  last name: Le Wang
  role: Principal Investigator
  affiliation: Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai 10th People's Hospital
  investigator full name: Huanlong Qin
  investigator title: Clinical Professor
  mesh term: Diarrhea