<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/NCT03026231</url>
  </required_header>
  <id_info>
    <org_study_id>UT-SPH/KRF FMT-2016-PD-01</org_study_id>
    <nct_id>NCT03026231</nct_id>
  </id_info>
  <brief_title>Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients</brief_title>
  <official_title>A Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kelsey Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to characterize the intestinal flora in subjects with&#xD;
      Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of&#xD;
      colonic microbiome following fecal microbiota transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    study will be started under a new modified protocol&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 15, 2017</start_date>
  <completion_date type="Actual">July 17, 2018</completion_date>
  <primary_completion_date type="Actual">July 17, 2018</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Most abundant Phylum in Fecal Sample</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Most abundant Phylum in Fecal Sample</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Most abundant Phylum in Fecal Sample</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of bowel movements per day</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of bowel movements per day</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of bowel movements per day</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)</measure>
    <time_frame>3 years</time_frame>
    <description>The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)</measure>
    <time_frame>1 day</time_frame>
    <description>The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)</measure>
    <time_frame>6 months</time_frame>
    <description>The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)</measure>
    <time_frame>12 months</time_frame>
    <description>The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a change in required anti-PD symptomatic or levodopa therapy</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)</measure>
    <time_frame>day 1 of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>day 1 of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>PRIM-DJ2727</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRIM-DJ2727</intervention_name>
    <description>Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules</description>
    <arm_group_label>PRIM-DJ2727</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for PRIM-DJ2727)</intervention_name>
    <description>Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis PD with a Hoehn and Yahr stage of &lt; 3 in the &quot;Off medicine&quot; state&#xD;
&#xD;
          -  Sexually active male and female subjects of child-bearing potential must agree to use&#xD;
             an effective method of birth control during the treatment and follow-up period&#xD;
&#xD;
          -  Female subjects of child-bearing potential must have a negative pregnancy test in the&#xD;
             72 hours before the procedure&#xD;
&#xD;
          -  Subject willing to sign an informed consent form&#xD;
&#xD;
          -  Subject deemed likely to survive for ≥ 1 year after enrolment&#xD;
&#xD;
          -  Subject's attending physician will refer and provide non-transplant care for the&#xD;
             subject&#xD;
&#xD;
          -  Subjects must demonstrate adherence to and the ability to maintain a Parkinson's&#xD;
             therapy medical regimen that is stable for 90 days before enrolment and participation&#xD;
             in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Greater than 20 grams of ethanol intake daily&#xD;
&#xD;
          -  Unstable Parkinson's disease&#xD;
&#xD;
          -  Other immune disorder or clinical immunosuppression&#xD;
&#xD;
          -  Probiotic used during study period&#xD;
&#xD;
          -  Severe underlying disease such that the subject is not expected to survive for one or&#xD;
             more years or unstable medical condition requiring frequent change in treatments&#xD;
&#xD;
          -  Current or recent within one month receipt of an antibiotic with expected activity&#xD;
             against enteric bacteria&#xD;
&#xD;
          -  Prior Deep Brain Stimulation, or surgical intervention for PD , intravenous&#xD;
             glutathione therapy or stem cell therapy&#xD;
&#xD;
          -  HIV or Hepatitis B / C positive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Herbert L DuPont, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <reference>
    <citation>Borody TJ, Paramsothy S, Agrawal G. Fecal microbiota transplantation: indications, methods, evidence, and future directions. Curr Gastroenterol Rep. 2013 Aug;15(8):337. doi: 10.1007/s11894-013-0337-1.</citation>
    <PMID>23852569</PMID>
  </reference>
  <reference>
    <citation>Fasano A, Bove F, Gabrielli M, Petracca M, Zocco MA, Ragazzoni E, Barbaro F, Piano C, Fortuna S, Tortora A, Di Giacopo R, Campanale M, Gigante G, Lauritano EC, Navarra P, Marconi S, Gasbarrini A, Bentivoglio AR. The role of small intestinal bacterial overgrowth in Parkinson's disease. Mov Disord. 2013 Aug;28(9):1241-9. doi: 10.1002/mds.25522. Epub 2013 May 27.</citation>
    <PMID>23712625</PMID>
  </reference>
  <reference>
    <citation>Nakane S, Yoshioka M, Oda N, Tani T, Chida K, Suzuki M, Funakawa I, Inukai A, Hasegawa K, Kuroda K, Mizoguchi K, Shioya K, Sonoda Y, Matsuo H. The characteristics of camptocormia in patients with Parkinson's disease: A large cross-sectional multicenter study in Japan. J Neurol Sci. 2015 Nov 15;358(1-2):299-303. doi: 10.1016/j.jns.2015.09.015. Epub 2015 Sep 8.</citation>
    <PMID>26428310</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Herbert DuPont</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Fecal microbiota transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT03026231
org study id: UT-SPH/KRF FMT-2016-PD-01
nct id: NCT03026231
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to characterize the intestinal flora in subjects with
      Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of
      colonic microbiome following fecal microbiota transplantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
time frame: 3 years
measure: Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
time frame: 6 months
measure: Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
time frame: 12 months
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
time frame: 3 years
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
time frame: 6 months
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
time frame: 12 months
measure: Most abundant Phylum in Fecal Sample
time frame: 3 years
measure: Most abundant Phylum in Fecal Sample
time frame: 6 months
measure: Most abundant Phylum in Fecal Sample
time frame: 12 months
measure: Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls
time frame: 3 years
measure: Number of bowel movements per day
time frame: 3 years
measure: Number of bowel movements per day
time frame: 6 months
measure: Number of bowel movements per day
time frame: 12 months
measure: Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
time frame: 3 years
description: The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
measure: Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
time frame: 1 day
description: The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
measure: Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
time frame: 6 months
description: The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
measure: Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
time frame: 12 months
description: The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
measure: Number of participants with a change in required anti-PD symptomatic or levodopa therapy
time frame: 12 months
measure: Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
time frame: 3 years
measure: Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
time frame: day 1 of treatment
measure: Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
time frame: 6 months
measure: Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
time frame: 12 months
measure: Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
time frame: 3 years
measure: Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
time frame: day 1 of treatment
measure: Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
time frame: 6 months
measure: Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
time frame: 12 months
measure: Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares
time frame: 12 months
arm group label: PRIM-DJ2727
arm group type: Active Comparator
description: Subjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules
arm group label: Placebo
arm group type: Placebo Comparator
description: Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules
intervention type: Biological
intervention name: PRIM-DJ2727
description: Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules
arm group label: PRIM-DJ2727
intervention type: Drug
intervention name: Placebo (for PRIM-DJ2727)
description: Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules
arm group label: Placebo
criteria: 
gender: All
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: No
last name: Herbert L DuPont, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
country: United States
citation: Borody TJ, Paramsothy S, Agrawal G. Fecal microbiota transplantation: indications, methods, evidence, and future directions. Curr Gastroenterol Rep. 2013 Aug;15(8):337. doi: 10.1007/s11894-013-0337-1.
PMID: 23852569
citation: Fasano A, Bove F, Gabrielli M, Petracca M, Zocco MA, Ragazzoni E, Barbaro F, Piano C, Fortuna S, Tortora A, Di Giacopo R, Campanale M, Gigante G, Lauritano EC, Navarra P, Marconi S, Gasbarrini A, Bentivoglio AR. The role of small intestinal bacterial overgrowth in Parkinson's disease. Mov Disord. 2013 Aug;28(9):1241-9. doi: 10.1002/mds.25522. Epub 2013 May 27.
PMID: 23712625
citation: Nakane S, Yoshioka M, Oda N, Tani T, Chida K, Suzuki M, Funakawa I, Inukai A, Hasegawa K, Kuroda K, Mizoguchi K, Shioya K, Sonoda Y, Matsuo H. The characteristics of camptocormia in patients with Parkinson's disease: A large cross-sectional multicenter study in Japan. J Neurol Sci. 2015 Nov 15;358(1-2):299-303. doi: 10.1016/j.jns.2015.09.015. Epub 2015 Sep 8.
PMID: 26428310
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Herbert DuPont
investigator title: Professor of Medicine
mesh term: Parkinson Disease