<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/NCT03268655</url>
  </required_header>
  <id_info>
    <org_study_id>SPH-2017-25928</org_study_id>
    <secondary_id>Anna-CPRC-TBD</secondary_id>
    <nct_id>NCT03268655</nct_id>
  </id_info>
  <brief_title>Ginger and Gut Microbiome (GINGER)</brief_title>
  <official_title>Pilot Trial to Examine the Effect of Ginger on the Gut Microbiome (GINGER)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Estimate the impact of a 6-week daily intake of 2000 mg of ginger extract on the composition&#xD;
      of the gut microbiome using a randomized placebo-controlled double-blinded design, i.e.&#xD;
      examine the change of microbiome over time within and between the subjects..&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot trial to evaluate the feasibility of conducting a large randomized trial and&#xD;
      estimate the effects of ginger extract on the gut microbiome. The pilot study will recruit&#xD;
      from multiple sites 95-100 subjects aged 50-75 years old who were diagnosed with colorectal&#xD;
      adenoma within the last five years. There will be 47-50 subjects in the treatment group and&#xD;
      47-50 in the placebo group. The subjects will be randomized to receive either 2000 mg of&#xD;
      ginger extract per day (1000 mg twice a day) or matching placebo.&#xD;
&#xD;
      Subjects will provide three stool specimens for analysis of the intestinal microbiome over a&#xD;
      12-week period at the following intervals: Week 0 (Day 1), Week 6, and Week 12. Although the&#xD;
      gut microbiome is stable within a period of 1-2 months, a control arm will be included to&#xD;
      account for potential dietary and other changes that may affect the gut microbiome. Gut&#xD;
      microbiome composition - the presence, abundance, and diversity of bacterial taxa - will be&#xD;
      derived by sequencing microbial 16S ribosomal RNA genes.&#xD;
&#xD;
      Primary Aims:&#xD;
&#xD;
      Aim 1 is to estimate the impact of a 6-week daily intake of 2000 mg of ginger extract on the&#xD;
      composition of the gut microbiome using a randomized placebo-controlled double-blinded&#xD;
      design, i.e. examine the change of microbiome over time within and between the subjects.&#xD;
&#xD;
      Aim 2 will examine the correlation between the ginger-related changes in microbiome profile&#xD;
      with the levels of circulating biomarkers: urinary Prostaglandin E (PGE) metabolites.&#xD;
&#xD;
      Hypothesis: In the ginger versus placebo arm, gut microbiome will shift towards a lower&#xD;
      proportion of pro-inflammatory, bacteria associated with colorectal cancer (CRC) and higher&#xD;
      proportion of anti-inflammatory, CRC-protective bacteria.&#xD;
&#xD;
      Secondary Aim:&#xD;
&#xD;
        1. At the end of the study, we expect to show that ginger decreases the relative abundance&#xD;
           of pro-inflammatory, CRC-predisposing taxa and increases the abundance of&#xD;
           anti-inflammatory, CRC-protective taxa, i.e., demonstrate that ginger boosts changes in&#xD;
           gut microbiome that are protective against CRC, as well as assess ginger-induced changes&#xD;
           in immune response.&#xD;
&#xD;
        2. The similarities of bacterial profiles will be compared between three time points&#xD;
           baseline and 6 Weeks and 12 Weeks to estimate whether 6-week is a sufficient time for&#xD;
           washout.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2018</start_date>
  <completion_date type="Actual">June 26, 2020</completion_date>
  <primary_completion_date type="Actual">June 26, 2020</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Pilot. Double-blind placebo-controlled randomized trial</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Composition of the gut microbiome</measure>
    <time_frame>Baseline to 6 Weeks</time_frame>
    <description>Fecal microbial diversity and the prevalence of specific taxa associated with colorectal cancer (e.g. Fusobacteria, butyrate producing bacteria) will be estimated at 6 weeks. The ginger-related changes in the prevalence of each taxon will be assessed individually and also combined into a microbiome index (the abundance of protective taxa will be included as a negative value).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine inflammatory biomarker</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>Urinary metabolite of Prostaglandin E2 (ng/mg of creatinine) will be measured before and after treatment with ginger. Changes in inflammatory markers will be correlated to changes in the microbial diversity and the microbiome composition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in gut microbiome composition</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Beta-diversity will be compared between three time points: baseline, 6 Weeks and 12 Weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Colorectal Adenoma</condition>
  <arm_group>
    <arm_group_label>Ginger extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ginger extract, 2000 mg daily for 6 weeks, followed by 6 week washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo, daily for 6 weeks, followed by 6 week washout.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ginger extract</intervention_name>
    <description>2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout</description>
    <arm_group_label>Ginger extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Colorectal adenoma diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or sensitivity to ginger&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  Unstable medical condition&#xD;
&#xD;
          -  Unstable diet or weight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Prizment, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota, Epidemiology and Community Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic Cancer Center</name>
      <address>
        <city>Albert Lea</city>
        <state>Minnesota</state>
        <zip>56007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Cancer Center</name>
      <address>
        <city>Austin</city>
        <state>Minnesota</state>
        <zip>55912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Essentia Health - Deer River</name>
      <address>
        <city>Deer River</city>
        <state>Minnesota</state>
        <zip>56636</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Essentia Health St Mary's - Detroit Lakes</name>
      <address>
        <city>Detroit Lakes</city>
        <state>Minnesota</state>
        <zip>56501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Essentia Health - Fosston Clinic</name>
      <address>
        <city>Fosston</city>
        <state>Minnesota</state>
        <zip>56542</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Grand Itasca Clinic &amp; Hospital</name>
      <address>
        <city>Grand Rapids</city>
        <state>Minnesota</state>
        <zip>55744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Range Medical Center</name>
      <address>
        <city>Hibbing</city>
        <state>Minnesota</state>
        <zip>55746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Cancer System</name>
      <address>
        <city>Mankato</city>
        <state>Minnesota</state>
        <zip>56001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epidemiology Clinical Research Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monticello Cancer Center</name>
      <address>
        <city>Monticello</city>
        <state>Minnesota</state>
        <zip>55362</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Essentia Health - Park Rapids Clinic</name>
      <address>
        <city>Park Rapids</city>
        <state>Minnesota</state>
        <zip>56470</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Northland Medical Center</name>
      <address>
        <city>Princeton</city>
        <state>Minnesota</state>
        <zip>55371</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Essentia Health -Virgina Clinic</name>
      <address>
        <city>Virginia</city>
        <state>Minnesota</state>
        <zip>55792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gingerol</keyword>
  <keyword>microbiome</keyword>
  <keyword>gut</keyword>
  <keyword>ginger</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The results of the study will be disseminated to various stakeholders through the publication of a manuscript in a peer-reviewed journal and through presentation at scientific meetings.</ipd_description>
  </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/NCT03268655
org study id: SPH-2017-25928
secondary id: Anna-CPRC-TBD
nct id: NCT03268655
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Estimate the impact of a 6-week daily intake of 2000 mg of ginger extract on the composition
      of the gut microbiome using a randomized placebo-controlled double-blinded design, i.e.
      examine the change of microbiome over time within and between the subjects..
This is a pilot trial to evaluate the feasibility of conducting a large randomized trial and
      estimate the effects of ginger extract on the gut microbiome. The pilot study will recruit
      from multiple sites 95-100 subjects aged 50-75 years old who were diagnosed with colorectal
      adenoma within the last five years. There will be 47-50 subjects in the treatment group and
      47-50 in the placebo group. The subjects will be randomized to receive either 2000 mg of
      ginger extract per day (1000 mg twice a day) or matching placebo.

      Subjects will provide three stool specimens for analysis of the intestinal microbiome over a
      12-week period at the following intervals: Week 0 (Day 1), Week 6, and Week 12. Although the
      gut microbiome is stable within a period of 1-2 months, a control arm will be included to
      account for potential dietary and other changes that may affect the gut microbiome. Gut
      microbiome composition - the presence, abundance, and diversity of bacterial taxa - will be
      derived by sequencing microbial 16S ribosomal RNA genes.

      Primary Aims:

      Aim 1 is to estimate the impact of a 6-week daily intake of 2000 mg of ginger extract on the
      composition of the gut microbiome using a randomized placebo-controlled double-blinded
      design, i.e. examine the change of microbiome over time within and between the subjects.

      Aim 2 will examine the correlation between the ginger-related changes in microbiome profile
      with the levels of circulating biomarkers: urinary Prostaglandin E (PGE) metabolites.

      Hypothesis: In the ginger versus placebo arm, gut microbiome will shift towards a lower
      proportion of pro-inflammatory, bacteria associated with colorectal cancer (CRC) and higher
      proportion of anti-inflammatory, CRC-protective bacteria.

      Secondary Aim:

        1. At the end of the study, we expect to show that ginger decreases the relative abundance
           of pro-inflammatory, CRC-predisposing taxa and increases the abundance of
           anti-inflammatory, CRC-protective taxa, i.e., demonstrate that ginger boosts changes in
           gut microbiome that are protective against CRC, as well as assess ginger-induced changes
           in immune response.

        2. The similarities of bacterial profiles will be compared between three time points
           baseline and 6 Weeks and 12 Weeks to estimate whether 6-week is a sufficient time for
           washout.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pilot. Double-blind placebo-controlled randomized trial
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: Double blind
measure: Composition of the gut microbiome
time frame: Baseline to 6 Weeks
description: Fecal microbial diversity and the prevalence of specific taxa associated with colorectal cancer (e.g. Fusobacteria, butyrate producing bacteria) will be estimated at 6 weeks. The ginger-related changes in the prevalence of each taxon will be assessed individually and also combined into a microbiome index (the abundance of protective taxa will be included as a negative value).
measure: Urine inflammatory biomarker
time frame: Baseline to 6 weeks
description: Urinary metabolite of Prostaglandin E2 (ng/mg of creatinine) will be measured before and after treatment with ginger. Changes in inflammatory markers will be correlated to changes in the microbial diversity and the microbiome composition
measure: Change in gut microbiome composition
time frame: Baseline to 12 weeks
description: Beta-diversity will be compared between three time points: baseline, 6 Weeks and 12 Weeks.
arm group label: Ginger extract
arm group type: Experimental
description: Ginger extract, 2000 mg daily for 6 weeks, followed by 6 week washout.
arm group label: Placebo
arm group type: Experimental
description: Placebo, daily for 6 weeks, followed by 6 week washout.
intervention type: Dietary Supplement
intervention name: Ginger extract
description: 2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
arm group label: Ginger extract
intervention type: Other
intervention name: Placebo
description: 2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Anna Prizment, PhD, MPH
role: Principal Investigator
affiliation: University of Minnesota, Epidemiology and Community Health
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Adenoma
sharing ipd: No
ipd description: The results of the study will be disseminated to various stakeholders through the publication of a manuscript in a peer-reviewed journal and through presentation at scientific meetings.