<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/NCT03786900</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-SPH-15-0991</org_study_id>
    <nct_id>NCT03786900</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation (FMT): PRIM-DJ2727</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herbert DuPont, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <brief_summary>
    <textblock>
      The Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 is prepared from human stool&#xD;
      from a healthy, screened donor.&#xD;
&#xD;
      Requestors will contact the study team about the product (PRIM-DJ2727) by email, visit, or&#xD;
      phone call. A screening list for donors will be provided to make sure that the list fits the&#xD;
      requestor's requirements. A basic fee will be requested to recover the cost of making the&#xD;
      product. After an agreement is made, a contract will be signed between the 2 parties. A week&#xD;
      before the treatment, requestors will contact the study team for possible FMT product&#xD;
      delivery. Delivery method will be confirmed for delivery by personnel (within 10 minutes&#xD;
      driving distance) or by using FedEx services. Each delivered product will have an approved&#xD;
      delivery form signed and dated by both the person who prepared the delivery and the person&#xD;
      who received the package.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <condition>Recurrent Clostridium Difficile Infection</condition>
  <condition>Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Herbert DuPont, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Herbert L DuPont, MD</last_name>
    <phone>713 500 9366</phone>
    <email>herbert.l.dupont@uth.tmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhi-Dong Jiang, MD, DrPH</last_name>
    <phone>713-500-9371</phone>
    <email>zhi-dong.jiang@uth.tmc.edu</email>
  </overall_contact_backup>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Herbert DuPont, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Clostridium Infections</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/NCT03786900
org study id: HSC-SPH-15-0991
nct id: NCT03786900
lead sponsor: 
The Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 is prepared from human stool
      from a healthy, screened donor.

      Requestors will contact the study team about the product (PRIM-DJ2727) by email, visit, or
      phone call. A screening list for donors will be provided to make sure that the list fits the
      requestor's requirements. A basic fee will be requested to recover the cost of making the
      product. After an agreement is made, a contract will be signed between the 2 parties. A week
      before the treatment, requestors will contact the study team for possible FMT product
      delivery. Delivery method will be confirmed for delivery by personnel (within 10 minutes
      driving distance) or by using FedEx services. Each delivered product will have an approved
      delivery form signed and dated by both the person who prepared the delivery and the person
      who received the package.
expanded access type individual: Yes
intervention type: Biological
intervention name: Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Herbert DuPont, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
last name: Herbert L DuPont, MD
phone: 713 500 9366
email: herbert.l.dupont@uth.tmc.edu
last name: Zhi-Dong Jiang, MD, DrPH
phone: 713-500-9371
email: zhi-dong.jiang@uth.tmc.edu
responsible party type: Sponsor-Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Herbert DuPont, MD
investigator title: Professor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
mesh term: Clostridium Infections