<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/NCT03247452</url>
  </required_header>
  <id_info>
    <org_study_id>Large bowel cleansing</org_study_id>
    <nct_id>NCT03247452</nct_id>
  </id_info>
  <brief_title>Impact of Low Fiber Diet on Colonic Cleansing Quality (DIETPREP)</brief_title>
  <acronym>DIETPREP</acronym>
  <official_title>Impact of Low Fiber Diet on Colonic Cleansing Quality Prior to Colonoscopy: Randomized Study Comparing 1 Day Versus 3 Days of Low Fiber Diet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario de Canarias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario de Canarias</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>
      This is a single center randomized controlled trial to compare bowel cleansing for outpatient&#xD;
      colonoscopy in two groups of participants: one group will receive instructions of one-day&#xD;
      structured low fiber diet whilst the other group will receive three-day low fiber diet.&#xD;
&#xD;
      Both groups will receive the same bowel cleansing solution (polyethylene glycol plus ascorbic&#xD;
      acid). Bowel cleansing will be assessed according the Boston Bowel Preparation Scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is well-known that low fiber diet before colonoscopy is at least equivalent to liquid&#xD;
      diet. However, tolerance is better with low fiber diet. There is no current evidence whether&#xD;
      the number of days on low fiber diet before colonoscopy have any influence on bowel cleansing&#xD;
      quality.&#xD;
&#xD;
      This is the first controlled, randomized trial to compare bowel cleansing by using two&#xD;
      different protocols: one day low fiber diet versus three day low fiber diet.&#xD;
&#xD;
      A researcher will offer to participate in the study to scheduled for outpatient colonoscopy,&#xD;
      who meet all the inclusion criteria and none of the exclusion criteria. The researchers will&#xD;
      explain the purpose of the study and will ask to sign the informed consent. They will give&#xD;
      verbal and written information on the diet and the bowel cleansing solution to be taken.&#xD;
      Thus, according to the allocation group, participants must comply with a low fiber diet the&#xD;
      previous day of the examination or 3 days prior to the examination. In both cases, patients&#xD;
      will take a liquid diet the night before.&#xD;
&#xD;
      Patients from both groups will receive low volume preparation with 1 L of polyethylene glycol&#xD;
      plus ascorbic acid 12 hours prior to the appointment of the colonoscopy and 1 L of PEG with&#xD;
      ascorbic acid 5 hours before the appointment for colonoscopy.&#xD;
&#xD;
      Patients must complete a baseline questionnaire at the inclusion visit and another&#xD;
      questionnaire at the colonoscopy visit.&#xD;
&#xD;
      The hypothesis of the study is that in non-selected population, a 3-day low fiber diet before&#xD;
      colonoscopy is superior to 1-day low fiber diet in achieving an acceptable bowel cleansing&#xD;
      assessed by a validated scale (Boston Bowel Preparation Score).&#xD;
&#xD;
      For the present study, a 10% improvement in the quality of colonic cleaning was hypothesized&#xD;
      in the group of patients receiving 3 day low fiber diet regimen. Taking into account a power&#xD;
      of 80%, alpha error of 5% and losses of 15% will require 202 patients per group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2017</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 31, 2018</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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Only the endoscopists in charged of rating cleansing quality during colonoscopy will be masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Boston Bowel Preparation Scale</measure>
    <time_frame>7 months</time_frame>
    <description>This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (Proximal, transverse and distal). Maximum punctuation is 9 points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of polyps detected in each arm</measure>
    <time_frame>7 months</time_frame>
    <description>Number of polyps detected in one arm/total of polyps detected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of satisfaction with diet</measure>
    <time_frame>7 months</time_frame>
    <description>It will be assessed using a visual scale (1 excellent to 10 unbearable)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">404</enrollment>
  <condition>Cleansing Quality of the Colon</condition>
  <arm_group>
    <arm_group_label>One-day low fiber diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients assigned to the active comparator will receive oral and written instructions about the same structured low fiber diet designed by an Endocrinologist but they will follow this diet only the day before colonoscopy.&#xD;
2 liters of polyethylene glycol plus ascorbic acid will be administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Three-day low fiber diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients assigned to the experimental group will receive oral and written instructions about a structured low fiber diet designed by an Endocrinologist. They must follow this diet three days before colonoscopy.&#xD;
2 liters of polyethylene glycol plus ascorbic acid will be administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>One-day Low fiber diet</intervention_name>
    <description>One-day low fiber diet before colonoscopy</description>
    <arm_group_label>One-day low fiber diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Three-day low fiber diet</intervention_name>
    <description>Three days low fiber diet before colonoscopy</description>
    <arm_group_label>Three-day low fiber diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polyethylene Glycol plus ascorbic acid</intervention_name>
    <description>2 liters of Polyethylene Glycol plus ascorbic acid will be administered to both groups</description>
    <arm_group_label>One-day low fiber diet</arm_group_label>
    <arm_group_label>Three-day low fiber diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous colon surgery&#xD;
&#xD;
          -  Last colonoscopy with poor bowel preparation&#xD;
&#xD;
          -  Ileus, intestinal obstruction, megacolon&#xD;
&#xD;
          -  Poorly controlled hypertension (HTAS&gt; 180 HTAD&gt; 100)&#xD;
&#xD;
          -  Terminal renal failure (pre-dialysis or dialysis)&#xD;
&#xD;
          -  Congestive heart failure (NYHA III-IV)&#xD;
&#xD;
          -  Acute liver failure&#xD;
&#xD;
          -  Severe psychiatric illness&#xD;
&#xD;
          -  Dementia with difficulty in the intake of the preparation&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Phenylketonuria&#xD;
&#xD;
          -  Deficiency of glucose-6-phosphate dehydrogenase&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  Inability to follow the instructions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enrique Quintero, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitario de Canarias</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gastroenterology</name>
      <address>
        <city>La Laguna</city>
        <state>Santa Cruz De Tenerife</state>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.</citation>
    <PMID>23335011</PMID>
  </results_reference>
  <results_reference>
    <citation>Song GM, Tian X, Ma L, Yi LJ, Shuai T, Zeng Z, Zeng XT. Regime for Bowel Preparation in Patients Scheduled to Colonoscopy: Low-Residue Diet or Clear Liquid Diet? Evidence From Systematic Review With Power Analysis. Medicine (Baltimore). 2016 Jan;95(1):e2432. doi: 10.1097/MD.0000000000002432.</citation>
    <PMID>26735547</PMID>
  </results_reference>
  <results_reference>
    <citation>Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.</citation>
    <PMID>28282690</PMID>
  </results_reference>
  <results_reference>
    <citation>Wu KL, Rayner CK, Chuah SK, Chiu KW, Lu CC, Chiu YC. Impact of low-residue diet on bowel preparation for colonoscopy. Dis Colon Rectum. 2011 Jan;54(1):107-12. doi: 10.1007/DCR.0b013e3181fb1e52.</citation>
    <PMID>21160321</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 14, 2018</last_update_submitted>
  <last_update_submitted_qc>August 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low fiber diet</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Bowel Cleansing</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascorbic Acid</mesh_term>
  </intervention_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/NCT03247452
org study id: Large bowel cleansing
nct id: NCT03247452
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single center randomized controlled trial to compare bowel cleansing for outpatient
      colonoscopy in two groups of participants: one group will receive instructions of one-day
      structured low fiber diet whilst the other group will receive three-day low fiber diet.

      Both groups will receive the same bowel cleansing solution (polyethylene glycol plus ascorbic
      acid). Bowel cleansing will be assessed according the Boston Bowel Preparation Scale.
It is well-known that low fiber diet before colonoscopy is at least equivalent to liquid
      diet. However, tolerance is better with low fiber diet. There is no current evidence whether
      the number of days on low fiber diet before colonoscopy have any influence on bowel cleansing
      quality.

      This is the first controlled, randomized trial to compare bowel cleansing by using two
      different protocols: one day low fiber diet versus three day low fiber diet.

      A researcher will offer to participate in the study to scheduled for outpatient colonoscopy,
      who meet all the inclusion criteria and none of the exclusion criteria. The researchers will
      explain the purpose of the study and will ask to sign the informed consent. They will give
      verbal and written information on the diet and the bowel cleansing solution to be taken.
      Thus, according to the allocation group, participants must comply with a low fiber diet the
      previous day of the examination or 3 days prior to the examination. In both cases, patients
      will take a liquid diet the night before.

      Patients from both groups will receive low volume preparation with 1 L of polyethylene glycol
      plus ascorbic acid 12 hours prior to the appointment of the colonoscopy and 1 L of PEG with
      ascorbic acid 5 hours before the appointment for colonoscopy.

      Patients must complete a baseline questionnaire at the inclusion visit and another
      questionnaire at the colonoscopy visit.

      The hypothesis of the study is that in non-selected population, a 3-day low fiber diet before
      colonoscopy is superior to 1-day low fiber diet in achieving an acceptable bowel cleansing
      assessed by a validated scale (Boston Bowel Preparation Score).

      For the present study, a 10% improvement in the quality of colonic cleaning was hypothesized
      in the group of patients receiving 3 day low fiber diet regimen. Taking into account a power
      of 80%, alpha error of 5% and losses of 15% will require 202 patients per group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
masking description: Only the endoscopists in charged of rating cleansing quality during colonoscopy will be masked.
measure: Boston Bowel Preparation Scale
time frame: 7 months
description: This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (Proximal, transverse and distal). Maximum punctuation is 9 points
measure: Proportion of polyps detected in each arm
time frame: 7 months
description: Number of polyps detected in one arm/total of polyps detected
measure: Degree of satisfaction with diet
time frame: 7 months
description: It will be assessed using a visual scale (1 excellent to 10 unbearable)
arm group label: One-day low fiber diet
arm group type: Active Comparator
description: Patients assigned to the active comparator will receive oral and written instructions about the same structured low fiber diet designed by an Endocrinologist but they will follow this diet only the day before colonoscopy.
2 liters of polyethylene glycol plus ascorbic acid will be administered
arm group label: Three-day low fiber diet
arm group type: Experimental
description: Patients assigned to the experimental group will receive oral and written instructions about a structured low fiber diet designed by an Endocrinologist. They must follow this diet three days before colonoscopy.
2 liters of polyethylene glycol plus ascorbic acid will be administered
intervention type: Other
intervention name: One-day Low fiber diet
description: One-day low fiber diet before colonoscopy
arm group label: One-day low fiber diet
intervention type: Other
intervention name: Three-day low fiber diet
description: Three days low fiber diet before colonoscopy
arm group label: Three-day low fiber diet
intervention type: Drug
intervention name: Polyethylene Glycol plus ascorbic acid
description: 2 liters of Polyethylene Glycol plus ascorbic acid will be administered to both groups
arm group label: One-day low fiber diet
arm group label: Three-day low fiber diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Enrique Quintero, MD, PhD
role: Study Director
affiliation: Hospital Universitario de Canarias
facility: 
country: Spain
citation: Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
PMID: 23335011
citation: Song GM, Tian X, Ma L, Yi LJ, Shuai T, Zeng Z, Zeng XT. Regime for Bowel Preparation in Patients Scheduled to Colonoscopy: Low-Residue Diet or Clear Liquid Diet? Evidence From Systematic Review With Power Analysis. Medicine (Baltimore). 2016 Jan;95(1):e2432. doi: 10.1097/MD.0000000000002432.
PMID: 26735547
citation: Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.
PMID: 28282690
citation: Wu KL, Rayner CK, Chuah SK, Chiu KW, Lu CC, Chiu YC. Impact of low-residue diet on bowel preparation for colonoscopy. Dis Colon Rectum. 2011 Jan;54(1):107-12. doi: 10.1007/DCR.0b013e3181fb1e52.
PMID: 21160321
responsible party type: Sponsor
mesh term: Ascorbic Acid