<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/NCT03772444</url>
  </required_header>
  <id_info>
    <org_study_id>EC/2017/1476</org_study_id>
    <nct_id>NCT03772444</nct_id>
  </id_info>
  <brief_title>Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.</brief_title>
  <acronym>BEET IT</acronym>
  <official_title>Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</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>
      The BEET IT study investigates the possible protective effect of beetroot juice on POI&#xD;
      following colorectal surgery in (partially) blinded single-center phase 2 randomized trial&#xD;
      (pilot study).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative ileus (POI) is a transient impairment of gastrointestinal motility following&#xD;
      abdominal surgery, which leads to increased morbidity, prolonged hospitalization and&#xD;
      increased healthcare cost. The pathogenesis of POI involves inflammation and oxidative&#xD;
      stress, similar to ischemia/reperfusion injury that can be counteracted with beetroot juice.&#xD;
      Beetroot juice is a source of inorganic nitrate, which by conversion of nitrate to nitrite in&#xD;
      the body, exerts its protective effect. We before demonstrated in a preclinical model that&#xD;
      administration of exogenous nitrite was shown to protect against POI. The aim of this pilot&#xD;
      study is to investigate the possible protective effect of beetroot juice ingestion on POI&#xD;
      following colorectal surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The pilot study was set up to assess whether the used dosing regimen of beetroot juice&#xD;
    demonstrated to reach the therapeutic objective. The study was terminated early, as the&#xD;
    deadline for the grant application for a larger study was approaching.&#xD;
  </why_stopped>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">May 25, 2019</completion_date>
  <primary_completion_date type="Actual">May 25, 2019</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Patients undergoing colorectal surgery will be randomized (n=10) to receive one week daily 70 ml of beetroot juice (~ 7 mmol inorganic nitrate) or (n=10) an equivalent volume of nitrate-depleted beetroot juice (control group 1). An additional control group (n=10) is added to the pilot study, in which patients will receive an equivalent volume of water (control group 2); this allows us to investigate whether the antioxidants present in beetroot juice contribute to the protective effect of beetroot juice in POI. Beetroot juice and nitrate-depleted beetroot juice cause discoloration of urine (beeturia) and feces from the purple betacyanin pigments in beetroot; for the control group that receives water, this will not be the case and blinding for this group is thus not possible.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time until recovery of gastrointestinal function.</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>Recovery of gastrointestinal function is defined as the interval (in days) from the end of surgery until passage of stool AND tolerance of solid food.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days).</measure>
    <time_frame>up to 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall post-operative complication rate defined according to the Clavien-Dindo Classification.</measure>
    <time_frame>3 months postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of prolonged postoperative ileus.</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>Prolonged postoperative ileus is defined as presence of 2 or more of the following criteria on or after day 4 postoperatively: nausea or vomiting, inability to tolerate a solid or semi-solid oral diet, abdominal distension, absence of flatus and stool, radiological evidence of ileus.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Postoperative Ileus</condition>
  <arm_group>
    <arm_group_label>Beetroot juice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group 2</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Beetroot juice</intervention_name>
    <description>Patients will drink 70 ml of beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.</description>
    <arm_group_label>Beetroot juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nitrate-depleted beetroot juice</intervention_name>
    <description>Patients will drink 70 ml of nitrate-depleted beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.</description>
    <arm_group_label>Control group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Water</intervention_name>
    <description>Patients will drink 70 ml of water in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.</description>
    <arm_group_label>Control group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • All patients undergoing colonic or upper rectum laparoscopic surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Psychiatric pathology capable of affecting comprehension and judgment faculty&#xD;
&#xD;
          -  History of metastatic disease&#xD;
&#xD;
          -  History of prior abdominal bowel surgery&#xD;
&#xD;
          -  Abdominal radiation treatment&#xD;
&#xD;
          -  Chronic constipation (defined as two or fewer bowel movements per week)&#xD;
&#xD;
          -  Gut motility influencing agents (e.g. tricyclic antidepressants, chronic use of&#xD;
             laxatives)&#xD;
&#xD;
          -  Frequent use of mouthwash, as this affects the enterosalivary circulation of nitrate&#xD;
&#xD;
          -  Current use of broad-spectrum antibiotics, which will affect the oral flora and likely&#xD;
             affect the nitrate reductase activity&#xD;
&#xD;
          -  More than one bowel anastomosis during this surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>January 18, 2023</last_update_submitted>
  <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ileus</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/NCT03772444
org study id: EC/2017/1476
nct id: NCT03772444
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The BEET IT study investigates the possible protective effect of beetroot juice on POI
      following colorectal surgery in (partially) blinded single-center phase 2 randomized trial
      (pilot study).
Postoperative ileus (POI) is a transient impairment of gastrointestinal motility following
      abdominal surgery, which leads to increased morbidity, prolonged hospitalization and
      increased healthcare cost. The pathogenesis of POI involves inflammation and oxidative
      stress, similar to ischemia/reperfusion injury that can be counteracted with beetroot juice.
      Beetroot juice is a source of inorganic nitrate, which by conversion of nitrate to nitrite in
      the body, exerts its protective effect. We before demonstrated in a preclinical model that
      administration of exogenous nitrite was shown to protect against POI. The aim of this pilot
      study is to investigate the possible protective effect of beetroot juice ingestion on POI
      following colorectal surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
masking description: Patients undergoing colorectal surgery will be randomized (n=10) to receive one week daily 70 ml of beetroot juice (~ 7 mmol inorganic nitrate) or (n=10) an equivalent volume of nitrate-depleted beetroot juice (control group 1). An additional control group (n=10) is added to the pilot study, in which patients will receive an equivalent volume of water (control group 2); this allows us to investigate whether the antioxidants present in beetroot juice contribute to the protective effect of beetroot juice in POI. Beetroot juice and nitrate-depleted beetroot juice cause discoloration of urine (beeturia) and feces from the purple betacyanin pigments in beetroot; for the control group that receives water, this will not be the case and blinding for this group is thus not possible.
measure: Time until recovery of gastrointestinal function.
time frame: up to 30 days after surgery
description: Recovery of gastrointestinal function is defined as the interval (in days) from the end of surgery until passage of stool AND tolerance of solid food.
measure: Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days).
time frame: up to 30 days after surgery
measure: Overall post-operative complication rate defined according to the Clavien-Dindo Classification.
time frame: 3 months postoperatively
measure: Presence of prolonged postoperative ileus.
time frame: up to 30 days after surgery
description: Prolonged postoperative ileus is defined as presence of 2 or more of the following criteria on or after day 4 postoperatively: nausea or vomiting, inability to tolerate a solid or semi-solid oral diet, abdominal distension, absence of flatus and stool, radiological evidence of ileus.
arm group label: Beetroot juice
arm group type: Active Comparator
arm group label: Control group 1
arm group type: Placebo Comparator
arm group label: Control group 2
arm group type: Sham Comparator
intervention type: Dietary Supplement
intervention name: Beetroot juice
description: Patients will drink 70 ml of beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
arm group label: Beetroot juice
intervention type: Dietary Supplement
intervention name: Nitrate-depleted beetroot juice
description: Patients will drink 70 ml of nitrate-depleted beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
arm group label: Control group 1
intervention type: Dietary Supplement
intervention name: Water
description: Patients will drink 70 ml of water in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
arm group label: Control group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Ileus
sharing ipd: No