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/NCT05973721</url>
    </required_header>
    <id_info>
      <org_study_id>PIB-phage</org_study_id>
      <nct_id>NCT05973721</nct_id>
    </id_info>
    <brief_title>Clinical Study of Phage Therapy for Chronic Constipation Efficacy and Safety</brief_title>
    <official_title>To Investigate the Clinical Efficacy and Safety of Phage Therapy for Chronic Constipation</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>
        The overall aim was to evaluate the efficacy of PiB-specific phages for the treatment of&#xD;
        refractory constipation through clinical studies, primarily for the publication of scientific&#xD;
        papers and to guide the development of phage therapies. The purpose of this study will be&#xD;
        subdivided into three aspects from three aspects: target exposure level, target occupation,&#xD;
        and functional effects after acting on the target, including:1) The distribution of PIB phage&#xD;
        in the intestine of patients with refractory constipation;2) The killing effect of PIB phage&#xD;
        on PIB bacteria in refractory constipation patients;And 3) therapeutic effect of PIB phage on&#xD;
        patients with refractory constipation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 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>To observe the curative effect of PIB phage on refractory constipation by defecation behavior of patients.</measure>
      <time_frame>Baseline and six months after treatment</time_frame>
      <description>Defecation behavior: A questionnaire was designed according to Rome IV criteria, and the questionnaire was collected and recorded, including the number of spontaneous bowel movements per week, PAC-QoL score, PAC-SYM score and Bristol stool trait score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The concentration of phage in feces was detected to evaluate the survival and survival ratio of active phage in the intestinal tract of patients.</measure>
      <time_frame>Baseline and 24-48 hours after phage administration (first bowel movement)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Real-time PCR was used to detect the nucleic acid of PIB bacteria and HPLC was used to detect the distribution of fecal PIB phage in the intestinal tract of patients with refractory constipation</measure>
      <time_frame>Baseline and two weeks after treatment</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Pib Specific Phage</condition>
    <condition>Intractable Constipation</condition>
    <arm_group>
      <arm_group_label>Phage treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>phage</intervention_name>
      <description>The treatment group was given one phage each time, once a day for two weeks</description>
      <arm_group_label>Phage treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients of both sexes, aged 18-70 years, with confirmed chronic constipation and&#xD;
               positive fecal bacteria test for PIB, agreed to participate in this experiment and&#xD;
               signed an informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe heart failure, hypertension, cerebrovascular disease (e.g. stroke, moyamoya&#xD;
               disease, etc.); Secondary constipation caused by psychotropic drug abuse; Pregnant or&#xD;
               lactating women.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hongliang Tian, Dr</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>
    <overall_contact>
      <last_name>Hongliang Tian, Dr</last_name>
      <phone>+86-18917688267</phone>
      <email>tianhl@tongji.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai Tenth People's Hospital</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hongliang Tian, Dr</last_name>
        <phone>+86-18917688267</phone>
        <email>tianhl@tongji.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 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>Constipation</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/NCT05973721
  org study id: PIB-phage
  nct id: NCT05973721
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The overall aim was to evaluate the efficacy of PiB-specific phages for the treatment of
        refractory constipation through clinical studies, primarily for the publication of scientific
        papers and to guide the development of phage therapies. The purpose of this study will be
        subdivided into three aspects from three aspects: target exposure level, target occupation,
        and functional effects after acting on the target, including:1) The distribution of PIB phage
        in the intestine of patients with refractory constipation;2) The killing effect of PIB phage
        on PIB bacteria in refractory constipation patients;And 3) therapeutic effect of PIB phage on
        patients with refractory constipation.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: To observe the curative effect of PIB phage on refractory constipation by defecation behavior of patients.
  time frame: Baseline and six months after treatment
  description: Defecation behavior: A questionnaire was designed according to Rome IV criteria, and the questionnaire was collected and recorded, including the number of spontaneous bowel movements per week, PAC-QoL score, PAC-SYM score and Bristol stool trait score
  measure: The concentration of phage in feces was detected to evaluate the survival and survival ratio of active phage in the intestinal tract of patients.
  time frame: Baseline and 24-48 hours after phage administration (first bowel movement)
  measure: Real-time PCR was used to detect the nucleic acid of PIB bacteria and HPLC was used to detect the distribution of fecal PIB phage in the intestinal tract of patients with refractory constipation
  time frame: Baseline and two weeks after treatment
  arm group label: Phage treatment group
  arm group type: Experimental
  intervention type: Biological
  intervention name: phage
  description: The treatment group was given one phage each time, once a day for two weeks
  arm group label: Phage treatment group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Hongliang Tian, Dr
  role: Principal Investigator
  affiliation: Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
  last name: Hongliang Tian, Dr
  phone: +86-18917688267
  email: tianhl@tongji.edu.cn
  facility: 
  status: Recruiting
  contact: 
  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: Constipation