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/NCT06020365</url>
    </required_header>
    <id_info>
      <org_study_id>FMT_CIPO</org_study_id>
      <nct_id>NCT06020365</nct_id>
    </id_info>
    <brief_title>Investigation of Fecal Microbiota Transplant in Chronic Intestinal Pseudo-obstruction Patients</brief_title>
    <acronym>FMT-CIP</acronym>
    <official_title>Investigation of Fecal Microbiota Transplant Treatment in Chronic Intestinal Pseudo-obstruction Patients</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>
        Chronic Intestinal Pseudo-Obstruction (CIPO) is a rare gastrointestinal disorder that&#xD;
        primarily affects the movement of the intestines, leading to symptoms that resemble a true&#xD;
        bowel obstruction but without a physical blockage. This condition is characterized by&#xD;
        impaired motility of the gastrointestinal tract, which can result in severe symptoms and&#xD;
        complications. In previous studies, the investigator found that sequential microbiota&#xD;
        transplantation therapy can improve clinical symptoms of chronic pseudo-obstruction. Building&#xD;
        on this foundation, the current study further investigates the effects of sequential&#xD;
        interventions involving intestinal cleansing, small intestine bacterial treatment, fecal&#xD;
        microbiota transplantation, and nutritional therapy on the short-term and long-term clinical&#xD;
        symptom improvement in patients. Additionally, the investigator aim to elucidate the changes&#xD;
        in gut microbiota phenotypes before and after treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2018</start_date>
    <completion_date type="Actual">August 1, 2023</completion_date>
    <primary_completion_date type="Actual">August 1, 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>Enteral Nutrition Tolerance</measure>
      <time_frame>8 weeks</time_frame>
      <description>the maximal amount of enteral nutrition allowed daily</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Nutrition Status</measure>
      <time_frame>52 weeks</time_frame>
      <description>intersectional muscle and fat area measurements by quantitative computed tomography</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Need for surgery</measure>
      <time_frame>52 weeks</time_frame>
      <description>Surgical interventions are performed due to intestinal nutritional intolerance, including procedures such as nutritional ostomy, decompression ostomy, and intestinal resection.</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes of both colerectal and small intestinal microbiota profile</measure>
      <time_frame>8 weeks</time_frame>
      <description>Both colorectal and small intestinal bacteria profile before and after treatment.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Intestinal Pseudo-Obstruction</condition>
    <condition>Fecal Microbiota Transplantation</condition>
    <arm_group>
      <arm_group_label>sequential antibiotics treatment and fecal + small intestinal microbiota transplant</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>sequential fecal microbiota transplant combined with small intestinal fluid transplant</intervention_name>
      <description>for eligible patients, the investigator use rifaximin, three times daily, 0.4 g each time, lasting 6 days followed by fecal microbiota transplant combined with small intestinal fluid transplant for 6 days. These procedures were repeated every 28 days.</description>
      <arm_group_label>sequential antibiotics treatment and fecal + small intestinal microbiota transplant</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. aged over 18 years old;&#xD;
  &#xD;
            2. met the current diagnosis criteria for Chronic Intestinal Pseudo-obstruction;&#xD;
  &#xD;
            3. can tolerate nasojejunal tube and complete full course of FMT treatment;&#xD;
  &#xD;
            4. the clinical data are relatively complete and there is follow-up available for&#xD;
               evaluation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;&#xD;
  &#xD;
            2. associated with gastrointestinal organic diseases such as short bowel syndrome,&#xD;
               intestinal fistula, and inflammatory bowel disease; c) severe destruction of the&#xD;
               intestinal mucosa, severe immunosuppression, combined with severe systemic infection;&#xD;
               d) Intervention with antibiotics during treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Shanghai Tenth People's Hospital</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 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 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>Dean of the hospital</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intestinal Pseudo-Obstruction</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/NCT06020365
  org study id: FMT_CIPO
  nct id: NCT06020365
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Chronic Intestinal Pseudo-Obstruction (CIPO) is a rare gastrointestinal disorder that
        primarily affects the movement of the intestines, leading to symptoms that resemble a true
        bowel obstruction but without a physical blockage. This condition is characterized by
        impaired motility of the gastrointestinal tract, which can result in severe symptoms and
        complications. In previous studies, the investigator found that sequential microbiota
        transplantation therapy can improve clinical symptoms of chronic pseudo-obstruction. Building
        on this foundation, the current study further investigates the effects of sequential
        interventions involving intestinal cleansing, small intestine bacterial treatment, fecal
        microbiota transplantation, and nutritional therapy on the short-term and long-term clinical
        symptom improvement in patients. Additionally, the investigator aim to elucidate the changes
        in gut microbiota phenotypes before and after treatment.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Enteral Nutrition Tolerance
  time frame: 8 weeks
  description: the maximal amount of enteral nutrition allowed daily
  measure: Nutrition Status
  time frame: 52 weeks
  description: intersectional muscle and fat area measurements by quantitative computed tomography
  measure: Need for surgery
  time frame: 52 weeks
  description: Surgical interventions are performed due to intestinal nutritional intolerance, including procedures such as nutritional ostomy, decompression ostomy, and intestinal resection.
  measure: Changes of both colerectal and small intestinal microbiota profile
  time frame: 8 weeks
  description: Both colorectal and small intestinal bacteria profile before and after treatment.
  arm group label: sequential antibiotics treatment and fecal + small intestinal microbiota transplant
  arm group type: Experimental
  intervention type: Other
  intervention name: sequential fecal microbiota transplant combined with small intestinal fluid transplant
  description: for eligible patients, the investigator use rifaximin, three times daily, 0.4 g each time, lasting 6 days followed by fecal microbiota transplant combined with small intestinal fluid transplant for 6 days. These procedures were repeated every 28 days.
  arm group label: sequential antibiotics treatment and fecal + small intestinal microbiota transplant
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai 10th People's Hospital
  investigator full name: Huanlong Qin
  investigator title: Dean of the hospital
  mesh term: Intestinal Pseudo-Obstruction
  sharing ipd: Yes