<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/NCT03823742</url>
  </required_header>
  <id_info>
    <org_study_id>H-43391</org_study_id>
    <nct_id>NCT03823742</nct_id>
  </id_info>
  <brief_title>Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?</brief_title>
  <official_title>Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</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>
      The purpose of this study is find out if we can use simple tests (biomarkers) to tell us if a&#xD;
      specific child would benefit most from CBT or from the low FODMAPs diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AIM 1: We will categorize children ages 7-12 yrs. of age with FGIDs (n=250) as to whether&#xD;
      they have/do not have one or more of the following abnormal physiologic changes: a) Autonomic&#xD;
      Nervous System imbalance as indicated by low heart rate variability; and/or (b) Abnormalities&#xD;
      in gut physiology: Impaired gut barrier function (increased permeability); and/or increased&#xD;
      abundance of species of Gammaproteobacteria and/or Clostridia; and/or Gut neuroimmune&#xD;
      dysfunction (increased fecal chromogranin A and secretogranin 2 concentrations).&#xD;
&#xD;
      AIM 2: Children will be randomized to the two treatments most commonly used in clinical&#xD;
      practice: CBT or a low FODMAP diet for a 3-week treatment period. We will compare the&#xD;
      response to the treatments in those with/without abnormal physiologic biomarkers at 3 weeks,&#xD;
      3 months, and 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 22, 2019</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</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>Sequential Assignment</intervention_model>
    <intervention_model_description>The proposed study is a randomized trial with a two group design. Children will be equally likely to be randomized to either CBT or a low FODMAP diet. There is no placebo treatment and no healthy controls are to be studied. Subjects will be stratified based on age (7-9 vs 10-12), sex, baseline pain (mean pain frequency: less than or equal to 50% of the rated intervals or &gt; 50% of the rated intervals, as reported on the baseline pain and stool diary) and PedsQL.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom Improvement</measure>
    <time_frame>3 to 4 weeks</time_frame>
    <description>Abdominal pain frequency or severity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>PedsQL or Functional Disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Improvement</measure>
    <time_frame>3 months</time_frame>
    <description>Abdominal pain frequency or severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>PedsQL or Functional Disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Improvement</measure>
    <time_frame>6 months</time_frame>
    <description>Abdominal pain frequency or severity</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Improvement in quality of life</measure>
    <time_frame>3 to 4 weeks</time_frame>
    <description>PedsQL or Functional Disability</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <condition>Functional Abdominal Pain Syndrome</condition>
  <condition>Functional Gastrointestinal Disorders</condition>
  <condition>Functional Bowel Disorder</condition>
  <condition>Functional Abdominal Pain</condition>
  <condition>Functional Abdominal Pain Disorders</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Behavioral Therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low FODMAP diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low FODMAP diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy</intervention_name>
    <description>Cognitive Behavioral Therapy (CBT): Study treatments for the child will be conducted by a psychologist or master's level therapist. Therapists will be provided with a standardized protocol for each session . CBT treatment will be given over 1 hour, once a week, for three weeks .</description>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low FODMAP Diet</intervention_name>
    <description>Low FODMAP Diet Condition: Subjects will receive detailed education by a dietitian about following a low FODMAP diet including a definition of FODMAPs, how to select low FODMAP foods, and how to read food labels to identify FODMAPS. The dietitian will contact the family for 1 hour, once a week, for three weeks.</description>
    <arm_group_label>Low FODMAP diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A child 7-12 years of age with a FGID will be recruited if the medical evaluation&#xD;
             reveals no organic reason for the abdominal pain and the child has abdominal pain that&#xD;
             meets the definition of a FGID (i.e., IBS, functional abdominal pain) according to the&#xD;
             pediatric Rome III criteria (Rome IV will be substituted when validated). Parents and&#xD;
             children must speak and understand English because of the psychological assessment and&#xD;
             CBT requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who have: had past bowel surgery; documented GI disorders (e.g., Crohn's&#xD;
             disease); a serious chronic medical condition (e.g., diabetes); weight and/or height &lt;&#xD;
             2 SD for age; chronic conditions with GI symptoms (e.g., cystic fibrosis); autism&#xD;
             spectrum disorder, significant developmental delay, psychosis, or a history of bipolar&#xD;
             disorder; been treated with antibiotics/probiotics within 2 mo. (because of effects on&#xD;
             gut microbiome analysis), and children who for some reason could not be randomized to&#xD;
             the low FODMAP diet.Vegetarian; children who are currently on the FODMAP Diet or&#xD;
             receiving CBT Children who speak only Spanish are not eligible because the Rome&#xD;
             questionnaire and psychological testing are not available in Spanish. Despite this, a&#xD;
             large proportion of the children enrolled will be Hispanic.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert J. Shulman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rona Levy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robert J. Shulman, MD</last_name>
    <phone>713 798-7178</phone>
    <email>rshulman@bcm.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cynthia A. Boutte, BSN</last_name>
    <phone>713 798-7178</phone>
    <email>cboutte@bcm.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Nutrition Research Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cynthia A. Boutte</last_name>
      <phone>713-798-7178</phone>
      <email>cboutte@bcm.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cynthia A. Boutte</last_name>
      <phone>713-798-7178</phone>
      <email>cboutte@bcm.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Robert Shulman, M.D.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Abdominal Pain</mesh_term>
    <mesh_term>Pain</mesh_term>
    <mesh_term>Somatoform Disorders</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/NCT03823742
org study id: H-43391
nct id: NCT03823742
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is find out if we can use simple tests (biomarkers) to tell us if a
      specific child would benefit most from CBT or from the low FODMAPs diet.
AIM 1: We will categorize children ages 7-12 yrs. of age with FGIDs (n=250) as to whether
      they have/do not have one or more of the following abnormal physiologic changes: a) Autonomic
      Nervous System imbalance as indicated by low heart rate variability; and/or (b) Abnormalities
      in gut physiology: Impaired gut barrier function (increased permeability); and/or increased
      abundance of species of Gammaproteobacteria and/or Clostridia; and/or Gut neuroimmune
      dysfunction (increased fecal chromogranin A and secretogranin 2 concentrations).

      AIM 2: Children will be randomized to the two treatments most commonly used in clinical
      practice: CBT or a low FODMAP diet for a 3-week treatment period. We will compare the
      response to the treatments in those with/without abnormal physiologic biomarkers at 3 weeks,
      3 months, and 6 months.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: The proposed study is a randomized trial with a two group design. Children will be equally likely to be randomized to either CBT or a low FODMAP diet. There is no placebo treatment and no healthy controls are to be studied. Subjects will be stratified based on age (7-9 vs 10-12), sex, baseline pain (mean pain frequency: less than or equal to 50% of the rated intervals or > 50% of the rated intervals, as reported on the baseline pain and stool diary) and PedsQL.
primary purpose: Treatment
masking: None (Open Label)
measure: Symptom Improvement
time frame: 3 to 4 weeks
description: Abdominal pain frequency or severity
measure: Improvement in quality of life
time frame: 3 months
description: PedsQL or Functional Disability
measure: Symptom Improvement
time frame: 3 months
description: Abdominal pain frequency or severity
measure: Improvement in quality of life
time frame: 6 months
description: PedsQL or Functional Disability
measure: Symptom Improvement
time frame: 6 months
description: Abdominal pain frequency or severity
measure: Improvement in quality of life
time frame: 3 to 4 weeks
description: PedsQL or Functional Disability
arm group label: Cognitive Behavioral Therapy
arm group type: Experimental
description: Cognitive Behavioral Therapy
arm group label: Low FODMAP diet
arm group type: Experimental
description: Low FODMAP diet
intervention type: Other
intervention name: Cognitive Behavioral Therapy
description: Cognitive Behavioral Therapy (CBT): Study treatments for the child will be conducted by a psychologist or master's level therapist. Therapists will be provided with a standardized protocol for each session . CBT treatment will be given over 1 hour, once a week, for three weeks .
arm group label: Cognitive Behavioral Therapy
intervention type: Other
intervention name: Low FODMAP Diet
description: Low FODMAP Diet Condition: Subjects will receive detailed education by a dietitian about following a low FODMAP diet including a definition of FODMAPs, how to select low FODMAP foods, and how to read food labels to identify FODMAPS. The dietitian will contact the family for 1 hour, once a week, for three weeks.
arm group label: Low FODMAP diet
criteria: 
gender: All
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: No
last name: Robert J. Shulman, MD
role: Principal Investigator
affiliation: Baylor College of Medicine
last name: Rona Levy, PhD
role: Principal Investigator
affiliation: University of Washington
last name: Robert J. Shulman, MD
phone: 713 798-7178
email: rshulman@bcm.edu
last name: Cynthia A. Boutte, BSN
phone: 713 798-7178
email: cboutte@bcm.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Robert Shulman, M.D.
investigator title: Professor
mesh term: Irritable Bowel Syndrome
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
mesh term: Intestinal Diseases
mesh term: Syndrome
mesh term: Chronic Pain
mesh term: Abdominal Pain
mesh term: Pain
mesh term: Somatoform Disorders
sharing ipd: No