<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/NCT02234518</url>
  </required_header>
  <id_info>
    <org_study_id>12.04.NRC</org_study_id>
    <nct_id>NCT02234518</nct_id>
  </id_info>
  <brief_title>Fibers and Gut Health</brief_title>
  <official_title>Evaluation of Changes in Gut Transit Time and Gastrointestinal Symptoms Following the Consumption of a Fiber Containing Product in Adults With Constipation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastrointestinal discomfort regularly affects &gt;25% of the population worldwide. One of the&#xD;
      major contributors to GI discomfort is constipation, which has a prevalence of ~15% and&#xD;
      symptoms of which have a significant negative impact on the sufferer's quality of life. One&#xD;
      of the hallmarks of chronic constipation is slow progression of contents through the gut&#xD;
      (i.e. slow gut / colonic transit time), which may be associated with hard stools that are&#xD;
      difficult to expel.&#xD;
&#xD;
      Dietary fiber supplements are widely used as a first-line treatment for constipation although&#xD;
      little Level 1 evidence exists to support its use in adults. The effectiveness of different&#xD;
      fiber supplements is difficult to compare given wide differences in water-retention&#xD;
      capabilities and effects on the colonic microbial ecology. Given the promising, yet largely&#xD;
      unsubstantiated, benefits of fiber supplementation on symptoms of functional constipation,&#xD;
      the objective of this clinical trial is to evaluate tolerance and effectiveness of four week&#xD;
      supplementation of a fiber product, in a dose-ranging fashion, on whole gut transit time and&#xD;
      gastrointestinal symptoms in adults with functional constipation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Whole gut transit time</measure>
    <time_frame>After 2 weeks consumption of the study product</time_frame>
    <description>To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing fiber in high quantity, compared to those consuming placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms</measure>
    <time_frame>After 2&amp;4 weeks consumption of the study product</time_frame>
    <description>To evaluate change in Gastrointestinal symptoms 2&amp;4 weeks after consumption of the study product in all groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional colonic transit time</measure>
    <time_frame>After 2 weeks consumption of the study product</time_frame>
    <description>To evaluate change in the regional (right colon, left colon, and rectosigmoid tranist time 2 weeks after consumption of the study product in all groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole gut transit time</measure>
    <time_frame>After 2 weeks consumption of the study product</time_frame>
    <description>To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing fiber in low quantity, compared to those consuming placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance</measure>
    <time_frame>After 1&amp;2&amp;4 weeks consumption of the study product</time_frame>
    <description>To assess tolerance to the study product 1&amp;2&amp;4 weeks after consumption in all groups, using a questionnaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Through the study product consumption period (4 weeks)</time_frame>
    <description>Adverse events assessed as treatment emergent adverse events (TEAEs)</description>
  </other_outcome>
  <other_outcome>
    <measure>Gut Health Insight Survey</measure>
    <time_frame>At screening, after informed consent</time_frame>
    <description>To gain insights into patient-specific constipation symptomology</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>High quantity fiber food product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low quantity fiber food product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High quantity fiber</intervention_name>
    <description>The intervention type is food product</description>
    <arm_group_label>High quantity fiber food product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low quantity fiber</intervention_name>
    <description>The intervention type is food product</description>
    <arm_group_label>Low quantity fiber food product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women aged 18-75; female subjects of child-bearing potential must be willing to&#xD;
             use a reliable method of contraception throughout the study period&#xD;
&#xD;
          -  BMI: 18.5 - 29.9 kg/m2&#xD;
&#xD;
          -  Recruitment based on simplified core ROME III diagnostic criteria for functional&#xD;
             constipation (based on specific screening questions):a). average Bristol stool type of&#xD;
             1 - 4 AND frequency of 1 - 3 spontaneous bowel movements (SBMs) per week b). plus at&#xD;
             least ONE of: straining on at least 25% of defaecations; sensation of incomplete&#xD;
             evacuation on at least 25% of defaecations; sensation of anorectal obstruction /&#xD;
             blockage on at least 25% of defaecations; use of manual manoeuvres on at least 25% of&#xD;
             defaecations&#xD;
&#xD;
          -  Cleveland Clinic constipation score (CCCS) of 8-20&#xD;
&#xD;
          -  Low-moderate fiber intake (≤18g) determined by the semi-quantitative food intake&#xD;
             screener known as the Block Fiber Screener&#xD;
&#xD;
          -  Ability to understand the patient information sheet and instructions in Dutch, and&#xD;
             able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who report lactose intolerance and/or are allergic to soy or cow milk protein&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Ongoing other diagnosed gastrointestinal disease or complication (Crohn's disease,&#xD;
             Coeliac disease, chronic diarrhoea)&#xD;
&#xD;
          -  Any clinical relevant abnormalities in the screening visit medical examination or&#xD;
             alarm features such as sudden unintentional weight loss, rectal bleeding, recent&#xD;
             change in bowel habit (&lt;3 months), abdominal pain and stool positive for occult blood&#xD;
&#xD;
          -  Prior abdominal surgery (including gastric bypass or laparoscopic banding), except&#xD;
             cholecystectomy and appendicectomy&#xD;
&#xD;
          -  Neurologic diseases such as multiple sclerosis, stroke, spinal cord injury,&#xD;
             Hirschsprung disease&#xD;
&#xD;
          -  Chronic medication that in opinion of the investigator would impact gut motility&#xD;
&#xD;
          -  Illness that may preclude the subject's ability to complete the study or that may&#xD;
             confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness,&#xD;
             severe cardiovascular disease, chronic renal failure or eating disorders) or any other&#xD;
             serious illness resulting in &gt;2 weeks inability to work in the 3 months before the&#xD;
             study start&#xD;
&#xD;
          -  Subjects with co-morbid illnesses such as cardiovascular, endocrine, renal or other&#xD;
             chronic disease likely to affect gut motility or limit normal functions (e.g. reduced&#xD;
             mobility or increased fragility)&#xD;
&#xD;
          -  Ongoing alcohol, drug, or medication abuse (anamnesis only)&#xD;
&#xD;
          -  Self-reported symptoms of pelvic organ prolapse&#xD;
&#xD;
          -  Moderate or severe active local anorectal problems such as recurrent anal fissures,&#xD;
             bleeding, large prolapsing haemorrhoids&#xD;
&#xD;
          -  Regular use of fiber supplementation (e.g. Fybogel, Lactulose) (i.e. no more than 1&#xD;
             standard dose) over the week prior to the screening visit and no more than 6 standard&#xD;
             doses in the past 1 month prior to the screening visit&#xD;
&#xD;
          -  Participation in another study with any investigational product within 3 months of&#xD;
             screening&#xD;
&#xD;
          -  Investigator believes that the participant is physically or mentally unfit to&#xD;
             participate in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diederick E. Grobbee, Prof, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Julius Clinical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Julius Clinical</name>
      <address>
        <city>Zeist</city>
        <zip>3703 CD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>November 9, 2015</last_update_submitted>
  <last_update_submitted_qc>November 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 10, 2015</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>Constipation</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/NCT02234518
org study id: 12.04.NRC
nct id: NCT02234518
lead sponsor: 
has dmc: No
Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the
      major contributors to GI discomfort is constipation, which has a prevalence of ~15% and
      symptoms of which have a significant negative impact on the sufferer's quality of life. One
      of the hallmarks of chronic constipation is slow progression of contents through the gut
      (i.e. slow gut / colonic transit time), which may be associated with hard stools that are
      difficult to expel.

      Dietary fiber supplements are widely used as a first-line treatment for constipation although
      little Level 1 evidence exists to support its use in adults. The effectiveness of different
      fiber supplements is difficult to compare given wide differences in water-retention
      capabilities and effects on the colonic microbial ecology. Given the promising, yet largely
      unsubstantiated, benefits of fiber supplementation on symptoms of functional constipation,
      the objective of this clinical trial is to evaluate tolerance and effectiveness of four week
      supplementation of a fiber product, in a dose-ranging fashion, on whole gut transit time and
      gastrointestinal symptoms in adults with functional constipation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Whole gut transit time
time frame: After 2 weeks consumption of the study product
description: To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing fiber in high quantity, compared to those consuming placebo
measure: Gastrointestinal symptoms
time frame: After 2&4 weeks consumption of the study product
description: To evaluate change in Gastrointestinal symptoms 2&4 weeks after consumption of the study product in all groups
measure: Regional colonic transit time
time frame: After 2 weeks consumption of the study product
description: To evaluate change in the regional (right colon, left colon, and rectosigmoid tranist time 2 weeks after consumption of the study product in all groups
measure: Whole gut transit time
time frame: After 2 weeks consumption of the study product
description: To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing fiber in low quantity, compared to those consuming placebo
measure: Tolerance
time frame: After 1&2&4 weeks consumption of the study product
description: To assess tolerance to the study product 1&2&4 weeks after consumption in all groups, using a questionnaire
measure: Adverse Events
time frame: Through the study product consumption period (4 weeks)
description: Adverse events assessed as treatment emergent adverse events (TEAEs)
measure: Gut Health Insight Survey
time frame: At screening, after informed consent
description: To gain insights into patient-specific constipation symptomology
arm group label: High quantity fiber food product
arm group type: Experimental
arm group label: Low quantity fiber food product
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Other
intervention name: High quantity fiber
description: The intervention type is food product
arm group label: High quantity fiber food product
intervention type: Other
intervention name: Low quantity fiber
description: The intervention type is food product
arm group label: Low quantity fiber food product
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Diederick E. Grobbee, Prof, MD, PhD
role: Principal Investigator
affiliation: Julius Clinical
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Constipation