<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/NCT03265639</url>
  </required_header>
  <id_info>
    <org_study_id>091440</org_study_id>
    <nct_id>NCT03265639</nct_id>
  </id_info>
  <brief_title>Prebiotics in Peritoneal Dialysis</brief_title>
  <official_title>Prebiotics in Peritoneal Dialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ali Ramezani</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Washington University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Prebiotics in Peritoneal Dialysis trial is a non-randomized, open-label, crossover study&#xD;
      of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 21, 2016</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change within-patient in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phases and the p-inulin treatment phase.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Within-patient change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment.</measure>
    <time_frame>24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)</time_frame>
    <description>Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within-patient variability in the bacterial composition of the stool during the no treatment phase.</measure>
    <time_frame>24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)</time_frame>
    <description>Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within-patient variability in the bacterial composition of the stool during the p-inulin treatment phase.</measure>
    <time_frame>24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)</time_frame>
    <description>Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within-patient change in the bacterial composition of the stool after p-inulin treatment compared with pre-treatment</measure>
    <time_frame>24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)</time_frame>
    <description>Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within-cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phase.</measure>
    <time_frame>24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)</time_frame>
    <description>Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within-cohort variability in the bacterial composition during the no treatment phase.</measure>
    <time_frame>24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)</time_frame>
    <description>Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within-cohort variability in the metabolomics profile and targeted metabolites/inflammatory markers during the p-inulin treatment phase.</measure>
    <time_frame>24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)</time_frame>
    <description>Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within-cohort variability in the bacterial composition during the p-inulin treatment phase.</measure>
    <time_frame>24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)</time_frame>
    <description>Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within-cohort change in the metabolomic profile and targeted metabolites/inflammatory markers after p-inulin treatment compared with pre-treatment</measure>
    <time_frame>24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)</time_frame>
    <description>Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within-cohort change in the bacterial composition after p-inulin treatment compared with pre-treatment.</measure>
    <time_frame>24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)</time_frame>
    <description>Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Score of the Gastrointestinal Symptom Rating Scale (GSRS)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants Who Discontinue Use of p-inulin</measure>
    <time_frame>8 week period of treatment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants Who Reduce the Dose of p-inulin</measure>
    <time_frame>8 week period of treatment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>24 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Enrollment Refusal Rate</measure>
    <time_frame>2 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of completed stool sample collections</measure>
    <time_frame>24 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of completed blood sample collections</measure>
    <time_frame>24 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adherence rate to p-inulin</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed by sachet counts</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of Study Withdrawal</measure>
    <time_frame>24 weeks</time_frame>
    <description>Number of subjects who withdrew during each phase</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>End Stage Renal Disease</condition>
  <condition>Gut Microbiome Dysbiosis</condition>
  <arm_group>
    <arm_group_label>Pre-treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm is the 8-week observation period before the p-inulin treatment phase.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm is the 8-week observation period after the p-inulin treatment phase.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>P-inulin</intervention_name>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Peritoneal dialysis therapy for end-stage renal disease&#xD;
&#xD;
          -  ≥30 days since dialysis initiation&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of pre- or pro-biotics during the past 2 months&#xD;
&#xD;
          -  Consumption of pro-biotic yogurt during the past 2 weeks&#xD;
&#xD;
          -  Use of antibiotics within the past 2 months&#xD;
&#xD;
          -  Presence of chronic infection&#xD;
&#xD;
          -  Chronic gastrointestinal condition other than constipation&#xD;
&#xD;
          -  Cirrhosis or chronic active hepatitis&#xD;
&#xD;
          -  Stomach/intestinal resection&#xD;
&#xD;
          -  PD access problems&#xD;
&#xD;
          -  Anticipated kidney transplant or transfer to another dialysis unit within 9 months&#xD;
&#xD;
          -  Expected survival &lt; 9 months&#xD;
&#xD;
          -  Pregnancy, anticipated pregnancy, or breastfeeding&#xD;
&#xD;
          -  Incarceration&#xD;
&#xD;
          -  Participation in another intervention study&#xD;
&#xD;
          -  Severe anemia defined as hemoglobin &lt;9.0 g/dl&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominic Raj, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The George Washington University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DaVita Georgetown Home Training Unit</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita K Street</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>February 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>November 16, 2018</last_update_submitted>
  <last_update_submitted_qc>November 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>George Washington University</investigator_affiliation>
    <investigator_full_name>Ali Ramezani</investigator_full_name>
    <investigator_title>Assistant Research Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Dysbiosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03265639
org study id: 091440
nct id: NCT03265639
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Prebiotics in Peritoneal Dialysis trial is a non-randomized, open-label, crossover study
      of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open label
measure: Change within-patient in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phases and the p-inulin treatment phase.
time frame: 24 weeks
description: Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.
measure: Within-patient change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment.
time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
description: Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.
measure: Within-patient variability in the bacterial composition of the stool during the no treatment phase.
time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
description: Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.
measure: Within-patient variability in the bacterial composition of the stool during the p-inulin treatment phase.
time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
description: Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.
measure: Within-patient change in the bacterial composition of the stool after p-inulin treatment compared with pre-treatment
time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
description: Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.
measure: Within-cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phase.
time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
description: Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.
measure: Within-cohort variability in the bacterial composition during the no treatment phase.
time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
description: Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.
measure: Within-cohort variability in the metabolomics profile and targeted metabolites/inflammatory markers during the p-inulin treatment phase.
time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
description: Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.
measure: Within-cohort variability in the bacterial composition during the p-inulin treatment phase.
time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
description: Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.
measure: Within-cohort change in the metabolomic profile and targeted metabolites/inflammatory markers after p-inulin treatment compared with pre-treatment
time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
description: Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.
measure: Within-cohort change in the bacterial composition after p-inulin treatment compared with pre-treatment.
time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
description: Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.
measure: Change in Score of the Gastrointestinal Symptom Rating Scale (GSRS)
time frame: 24 weeks
description: Gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS)
measure: Number of Participants Who Discontinue Use of p-inulin
time frame: 8 week period of treatment
measure: Number of Participants Who Reduce the Dose of p-inulin
time frame: 8 week period of treatment
measure: Number of Adverse Events
time frame: 24 weeks
measure: Enrollment Refusal Rate
time frame: 2 years
measure: Proportion of completed stool sample collections
time frame: 24 weeks
measure: Proportion of completed blood sample collections
time frame: 24 weeks
measure: Adherence rate to p-inulin
time frame: 8 weeks
description: Assessed by sachet counts
measure: Rate of Study Withdrawal
time frame: 24 weeks
description: Number of subjects who withdrew during each phase
arm group label: Pre-treatment
arm group type: No Intervention
description: This arm is the 8-week observation period before the p-inulin treatment phase.
arm group label: Intervention
arm group type: Experimental
description: This arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral).
arm group label: Post-treatment
arm group type: No Intervention
description: This arm is the 8-week observation period after the p-inulin treatment phase.
intervention type: Dietary Supplement
intervention name: P-inulin
arm group label: Intervention
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Dominic Raj, MD
role: Principal Investigator
affiliation: The George Washington University
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: George Washington University
investigator full name: Ali Ramezani
investigator title: Assistant Research Professor
mesh term: Kidney Failure, Chronic
mesh term: Dysbiosis
sharing ipd: No