<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/NCT02193997</url>
  </required_header>
  <id_info>
    <org_study_id>201203734</org_study_id>
    <nct_id>NCT02193997</nct_id>
  </id_info>
  <brief_title>Constipation Fiber Trial</brief_title>
  <official_title>Double-blind, Placebo-controlled Study to Examine the Effects of Dietary Fiber in Treating Childhood Constipation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Warren Bishop</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</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>
      This study examines the effects of dietary fiber in the treatment of functional childhood&#xD;
      constipation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 4-week double-blind, placebo-controlled study to examine the effects of dietary&#xD;
      fiber in treating functional childhood constipation. The addition of fiber is anticipated to&#xD;
      allow children to have more normal stool consistency and frequency.&#xD;
&#xD;
      All participants will be asked to take a snack bar twice daily and will be randomized in a&#xD;
      1:1:1 ratio to fiber 1, fiber 2 or placebo snack bar groups. All participants will be asked&#xD;
      to take low-dose Miralax to avoid worsening of constipation in all groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in stool frequency</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in stool consistency</measure>
    <time_frame>4 weeks</time_frame>
    <description>Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Functional Constipation in Children</condition>
  <arm_group>
    <arm_group_label>Fiber 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fiber 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Bar with low fiber content (placebo) once daily for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fiber</intervention_name>
    <arm_group_label>Fiber 1</arm_group_label>
    <other_name>Single fiber type</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fiber</intervention_name>
    <arm_group_label>Fiber 2</arm_group_label>
    <other_name>Blend of fiber types</other_name>
  </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;
          -  2-16 years of age with functional constipation as defined based on the Rome III&#xD;
             criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Constipation attributable to organic and anatomic causes or intake of medication&#xD;
&#xD;
          -  Children who had previous surgery of the colon or anus&#xD;
&#xD;
          -  History of allergy/intolerance to components of snack bar (e.g. celiac disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Warren Bishop, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Warren Bishop</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </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/NCT02193997
org study id: 201203734
nct id: NCT02193997
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study examines the effects of dietary fiber in the treatment of functional childhood
      constipation.
This is a 4-week double-blind, placebo-controlled study to examine the effects of dietary
      fiber in treating functional childhood constipation. The addition of fiber is anticipated to
      allow children to have more normal stool consistency and frequency.

      All participants will be asked to take a snack bar twice daily and will be randomized in a
      1:1:1 ratio to fiber 1, fiber 2 or placebo snack bar groups. All participants will be asked
      to take low-dose Miralax to avoid worsening of constipation in all groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in stool frequency
time frame: 4 weeks
measure: Change in stool consistency
time frame: 4 weeks
description: Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end
arm group label: Fiber 1
arm group type: Experimental
description: Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks
arm group label: Fiber 2
arm group type: Experimental
description: Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Bar with low fiber content (placebo) once daily for 4 weeks
intervention type: Other
intervention name: Fiber
arm group label: Fiber 1
other name: Single fiber type
intervention type: Other
intervention name: Fiber
arm group label: Fiber 2
other name: Blend of fiber types
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 2 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Warren Bishop, MD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Warren Bishop
investigator title: MD
mesh term: Constipation