<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/NCT03771027</url>
  </required_header>
  <id_info>
    <org_study_id>2015/17/N/NZ5/02596</org_study_id>
    <nct_id>NCT03771027</nct_id>
  </id_info>
  <brief_title>Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.</brief_title>
  <official_title>Evaluation of the Effectiveness of the Low FODMAP Diet in the Treatment of Functional Abdominal Pain in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Warmia and Mazury</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Centre, Poland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Warmia and Mazury</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>
      Diet components are important factors in pathogenesis of functional gastrointestinal&#xD;
      disorders, especially in the irritable bowel syndrome. Fermentable oligosaccharides,&#xD;
      disaccharides, monosaccharides and polyols (FODMAP) are a group of short chain, poorly&#xD;
      absorbed and osmotically active carbohydrates, which can induce gastrointestinal symptoms&#xD;
      because of rapid fermentation in different segments of the gut. Low FODMAP diet is a novel&#xD;
      treatment option with proven efficacy in reducing symptoms of functional gastrointestinal&#xD;
      disorders in adults. Conversely, although functional abdominal pain is a common health&#xD;
      problem in children, the efficacy of a low FODMAP diet remains understudied in this&#xD;
      population.&#xD;
&#xD;
      The aim of this study was to compare the effects of two diets: a low FODMAP diet and a diet&#xD;
      based on standard dietary advice of the National Institute for Health and Care Excellence&#xD;
      (NICE), on abdominal symptoms in children with functional abdominal pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2017</start_date>
  <completion_date type="Actual">December 8, 2017</completion_date>
  <primary_completion_date type="Actual">December 8, 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of abdominal pain severity</measure>
    <time_frame>6 weeks</time_frame>
    <description>Wong-Baker FACES Pain Rating Scale where 0 = no hurt and 10 = hurts worst was used for assessed severity of abdominal pain during the 6-week study period (2 weeks before and 4 weeks during the diet)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of abdominal pain and defecation frequency</measure>
    <time_frame>6 weeks</time_frame>
    <description>Abdominal pain and defecation frequency were recorded as number per day.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment of stool consistency</measure>
    <time_frame>6 weeks</time_frame>
    <description>Stool consistency was assessed using the validated Bristol Stool Form Scale. Type 1 or 2 were classified as the hard or lumpy stool, type 6 or 7 as the loose or waterly stool, and type 3-5 as the normal stool.</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of nutritional status</measure>
    <time_frame>4 months</time_frame>
    <description>Parameters of nutritional status before diet: weight (kilograms), height (meters).</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of physical activity</measure>
    <time_frame>4 months</time_frame>
    <description>The level of physical activity was established used the MVPA indicator (Moderate to Vigorous Physical Activity)</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of well-being of the patient</measure>
    <time_frame>3 weeks</time_frame>
    <description>Declarations of parents about symptoms changes in children during diet intervention based on a seven-point Likert scale (from 'much worse' to 'never occurred')</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Functional Abdominal Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Low FODMAP diet group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>four weeks of the low FODMAP diet based on Monash University low FODMAP diet App.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>four weeks of the diet based on NICE guidelines and contained products with different FODMAP content</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The low FODMAP diet.</intervention_name>
    <description>The low FODMAP group had reduced the intake of FODMAP. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.</description>
    <arm_group_label>Low FODMAP diet group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The diet based on NICE guidelines.</intervention_name>
    <description>The control group based on NICE guidelines received diet contained products with different FODMAP content. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  functional abdominal pain according to Rome III criteria&#xD;
&#xD;
          -  consent to participate in the study&#xD;
&#xD;
          -  positive decision of gastroenterologist concerning enrolment of the patient to the&#xD;
             trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  organic causes for gastrointestinal tract disorders,&#xD;
&#xD;
          -  occurrence of an abdominal migraine, IBS, food allergies or intolerances, other&#xD;
             significant disorders, acute infection&#xD;
&#xD;
          -  antibiotic treatment within the last 8 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katarzyna M Boradyn, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elżbieta Jarocka-Cyrta, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum Faculty of Medicine, University of Warmia and Mazury</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katarzyna E Przybyłowicz, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regional Specialized Children's Hospital</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-561</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Warmia and Mazury</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-719</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Warmia and Mazury</investigator_affiliation>
    <investigator_full_name>Katarzyna Boradyn</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>low FODMAP diet</keyword>
  <keyword>functional abdominal pain</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Pain</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/NCT03771027
org study id: 2015/17/N/NZ5/02596
nct id: NCT03771027
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diet components are important factors in pathogenesis of functional gastrointestinal
      disorders, especially in the irritable bowel syndrome. Fermentable oligosaccharides,
      disaccharides, monosaccharides and polyols (FODMAP) are a group of short chain, poorly
      absorbed and osmotically active carbohydrates, which can induce gastrointestinal symptoms
      because of rapid fermentation in different segments of the gut. Low FODMAP diet is a novel
      treatment option with proven efficacy in reducing symptoms of functional gastrointestinal
      disorders in adults. Conversely, although functional abdominal pain is a common health
      problem in children, the efficacy of a low FODMAP diet remains understudied in this
      population.

      The aim of this study was to compare the effects of two diets: a low FODMAP diet and a diet
      based on standard dietary advice of the National Institute for Health and Care Excellence
      (NICE), on abdominal symptoms in children with functional abdominal pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Assessment of abdominal pain severity
time frame: 6 weeks
description: Wong-Baker FACES Pain Rating Scale where 0 = no hurt and 10 = hurts worst was used for assessed severity of abdominal pain during the 6-week study period (2 weeks before and 4 weeks during the diet)
measure: Assessment of abdominal pain and defecation frequency
time frame: 6 weeks
description: Abdominal pain and defecation frequency were recorded as number per day.
measure: Assessment of stool consistency
time frame: 6 weeks
description: Stool consistency was assessed using the validated Bristol Stool Form Scale. Type 1 or 2 were classified as the hard or lumpy stool, type 6 or 7 as the loose or waterly stool, and type 3-5 as the normal stool.
measure: Assessment of nutritional status
time frame: 4 months
description: Parameters of nutritional status before diet: weight (kilograms), height (meters).
measure: Assessment of physical activity
time frame: 4 months
description: The level of physical activity was established used the MVPA indicator (Moderate to Vigorous Physical Activity)
measure: Assessment of well-being of the patient
time frame: 3 weeks
description: Declarations of parents about symptoms changes in children during diet intervention based on a seven-point Likert scale (from 'much worse' to 'never occurred')
arm group label: Low FODMAP diet group
arm group type: Experimental
description: four weeks of the low FODMAP diet based on Monash University low FODMAP diet App.
arm group label: Control group
arm group type: Active Comparator
description: four weeks of the diet based on NICE guidelines and contained products with different FODMAP content
intervention type: Other
intervention name: The low FODMAP diet.
description: The low FODMAP group had reduced the intake of FODMAP. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.
arm group label: Low FODMAP diet group
intervention type: Other
intervention name: The diet based on NICE guidelines.
description: The control group based on NICE guidelines received diet contained products with different FODMAP content. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.
arm group label: Control group
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
healthy volunteers: No
last name: Katarzyna M Boradyn, MSc
role: Principal Investigator
affiliation: Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
last name: Elżbieta Jarocka-Cyrta, Ph.D
role: Principal Investigator
affiliation: Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum Faculty of Medicine, University of Warmia and Mazury
last name: Katarzyna E Przybyłowicz, Ph.D
role: Principal Investigator
affiliation: Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
facility: 
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: University of Warmia and Mazury
investigator full name: Katarzyna Boradyn
investigator title: Principal Investigator
mesh term: Abdominal Pain
sharing ipd: No