<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/NCT02984059</url>
  </required_header>
  <id_info>
    <org_study_id>The ALLAY Study</org_study_id>
    <nct_id>NCT02984059</nct_id>
  </id_info>
  <brief_title>Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease</brief_title>
  <official_title>A Pilot Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease: The ALLAY Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Connecticut Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Connecticut Children's Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To characterize persistent abdominal pain in children with inflammatory bowel disease (IBD)&#xD;
      by examining factors such as disease type, activity and location, psychosocial factors, and&#xD;
      genetics.&#xD;
&#xD;
      The investigators hypothesize that by using patient pain and psychological assessments in&#xD;
      addition to analysis of blood, stool and colonic biopsies, we can better characterize factors&#xD;
      that predispose children and adolescents with IBD to have persistent and/or disproportionate&#xD;
      abdominal pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective longitudinal inception cohort pilot study. The study will hopefully&#xD;
      provide information about why there is persistent abdominal pain in children with IBD by&#xD;
      examining factors such as disease type, activity and location, psychosocial factors, and&#xD;
      genetics. Fifty newly diagnosed pediatric IBD patients, age 8-17 years will be enrolled into&#xD;
      the study. There will be 2 control groups as well: pain control population: 20 patients with&#xD;
      irritable bowel syndrome (IBS) or functional abdominal pain (FAP) diagnosis who have no&#xD;
      evidence of bowel inflammation will serve as a pain control population for patients with no&#xD;
      active inflammation. To serve as a control population for patients with no abdominal pain or&#xD;
      inflammation, the investigators will include 10 patients with no gastrointestinal symptoms,&#xD;
      who undergo colonoscopy for various reasons such as painless rectal bleeding, polyp&#xD;
      surveillance, etc. The investigators anticipate completing enrollment in 12 months and&#xD;
      allowed another 12 months for follow-up.&#xD;
&#xD;
      The study participants will be seen every 3 months for a year and they will have the&#xD;
      following procedures/test performed:&#xD;
&#xD;
        1. Standard of care blood and stool samples&#xD;
&#xD;
        2. Pediatric Ulcerative Colitis Activity Index (PUCAI) or Pediatric Crohn's Disease&#xD;
           Activity Index (PCDAI)&#xD;
&#xD;
      They will have an endoscopy performed at diagnosis then at 12 months from enrollment.&#xD;
&#xD;
      A magnetic resonance enterography (MRE) will be done at diagnosis.&#xD;
&#xD;
      The following pain and anxiety tests will be performed throughout the study:&#xD;
&#xD;
      Pain:&#xD;
&#xD;
      Pain Severity Duration Scale (PSDS) Pediatric Catastrophizing Scale-Child/Parents (PCS-C/P)&#xD;
      Pain Burden Interview (PBI) Adolescent Pediatric Pain Tool (APPT)&#xD;
&#xD;
      Anxiety:&#xD;
&#xD;
      Revised Children's Anxiety and Depression Scale (RCADS-25) Children's Somatization Index&#xD;
      (CSI-24) Adult Responses to Children's Symptoms (ARCS)&#xD;
&#xD;
      Blood, rectal biopsies and stool specimens will be obtained throughout various time points of&#xD;
      the study to look at hematology, sed rates, C-reactive protein, genomic DNA, colon RNA, stool&#xD;
      microbiome and stool calprotectin.&#xD;
&#xD;
      In summary, the investigators will be examining:&#xD;
&#xD;
        1. Relationship between clinical factors and persistent abdominal pain in patients with IBD&#xD;
&#xD;
             1. Disease type&#xD;
&#xD;
             2. Location of disease at diagnosis&#xD;
&#xD;
             3. Extent of disease at diagnosis&#xD;
&#xD;
             4. Markers of inflammation at diagnosis and over the course of follow up&#xD;
&#xD;
             5. Active disease vs. inactive disease over the course of follow up&#xD;
&#xD;
        2. Relationship between psychosocial factors persistent abdominal pain, and remission&#xD;
           status, specifically in patients with:&#xD;
&#xD;
             1. Inactive IBD vs. active IBD&#xD;
&#xD;
             2. Inactive IBD vs. IBS/FAP&#xD;
&#xD;
             3. We will compare the parental report to patient report in the above mentioned groups&#xD;
&#xD;
        3. Relationship between gene expression, microbiome, persistent abdominal pain, and&#xD;
           remission status, specifically in patients with:&#xD;
&#xD;
             1. Inactive IBD vs. active IBD&#xD;
&#xD;
             2. Inactive IBD vs. IBS/FAP&#xD;
&#xD;
             3. Inactive IBD vs. controls with no abdominal pain&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 21, 2015</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in abdominal pain from baseline at 3, 6, 9, and 12 months will be assessed using questionnaires</measure>
    <time_frame>Assessed at baseline then at months 3, 6, 9, and 12</time_frame>
    <description>Changes in abdominal pain from baseline then assessed again at 3, 6, 9, and 12 months.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">126</enrollment>
  <condition>Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>IBD w/abdominal pain</arm_group_label>
    <description>Patients with IBD with abdominal pain. Extra colonic biopsies for RNA analysis. If blood and stool samples are collected for standard of care:blood analyzed for both genomic DNA and calprotectin, and stool analyzed for microbiome. If no blood is drawn then a buccal swab done for the genomic DNA analysis and stool analyzed for calprotectin.&#xD;
Pain questionnaires:&#xD;
Pain Frequency-Severity-Duration Scale Pain Catastrophizing Scale-Child Version Pain Burden Interview Pediatric Quality of Life Inventory Adolescent Pediatric Pain Tool Anxiety/Depression Questionnaires Revised Children's Anxiety and Depression Scale Children's Somatization Inventory Adult Responses to Children's Symptoms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IBD w/out abdominal pain</arm_group_label>
    <description>Patients with IBD and no abdominal pain. Colonoscopy done for standard of care, extra colonic biopsies for RNA analysis. If blood and stool samples are collected for standard of care:blood analyzed for genomic DNA and calprotectin and stool analyzed for microbiome. If no blood is drawn then a buccal swab for the genomic DNA analysis and stool analyzed for calprotectin.&#xD;
Pain questionnaires:&#xD;
Pain Frequency-Severity-Duration Scale Pain Catastrophizing Scale-Child Version Pain Burden Interview Pediatric Quality of Life Inventory Adolescent Pediatric Pain Tool Anxiety/Depression Questionnaires Revised Children's Anxiety and Depression Scale Children's Somatization Inventory Adult Responses to Children's Symptoms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colonoscopy other reasons no abd pain</arm_group_label>
    <description>Patients who have a colonoscopy for other reasons, rectal bleeding or polyp surveillance, no abdominal pain. Extra colonic biopsies for RNA analysis. If blood and stool samples are collected for standard of care:blood analyzed for genomic DNA and calprotectin and stool analyzed for microbiome. If no blood is drawn then a buccal swab for the genomic DNA analysis and stool analyzed for calprotectin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Genomic DNA</intervention_name>
    <description>blood draw</description>
    <arm_group_label>Colonoscopy other reasons no abd pain</arm_group_label>
    <arm_group_label>IBD w/abdominal pain</arm_group_label>
    <arm_group_label>IBD w/out abdominal pain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>RNA analysis</intervention_name>
    <description>Mucosal Biopsy via colonoscopy</description>
    <arm_group_label>Colonoscopy other reasons no abd pain</arm_group_label>
    <arm_group_label>IBD w/abdominal pain</arm_group_label>
    <arm_group_label>IBD w/out abdominal pain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Microbiome</intervention_name>
    <description>Stool microbiome</description>
    <arm_group_label>Colonoscopy other reasons no abd pain</arm_group_label>
    <arm_group_label>IBD w/abdominal pain</arm_group_label>
    <arm_group_label>IBD w/out abdominal pain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Calprotectin</intervention_name>
    <description>stool or blood analysis for calprotectin</description>
    <arm_group_label>Colonoscopy other reasons no abd pain</arm_group_label>
    <arm_group_label>IBD w/abdominal pain</arm_group_label>
    <arm_group_label>IBD w/out abdominal pain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain questionnaires</intervention_name>
    <description>PSDS PCS-C/P PBI APPT</description>
    <arm_group_label>IBD w/abdominal pain</arm_group_label>
    <arm_group_label>IBD w/out abdominal pain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anxiety/Depression Questionnaires</intervention_name>
    <description>RCADS-25 CSI-24 ARCS</description>
    <arm_group_label>IBD w/abdominal pain</arm_group_label>
    <arm_group_label>IBD w/out abdominal pain</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      pending&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study participants will be recruited from the GI clinic here at Connecticut Children's&#xD;
        Medical Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 8 years or &lt; 18 years (achieved 8th birthday but not yet their 18th birthday)&#xD;
&#xD;
          -  IBD established by standard criteria&#xD;
&#xD;
          -  Anticipated availability for follow up for ≥ 1 year&#xD;
&#xD;
          -  Informed consent/assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior abdominal surgery unrelated to IBD&#xD;
&#xD;
          -  Active gastrointestinal infection at time of diagnosis (e.g., C. difficile)&#xD;
&#xD;
          -  Other co-morbidities that contribute to abdominal pain (e.g., Familial Mediterranean&#xD;
             Fever, metabolic disease)&#xD;
&#xD;
          -  Preexisting chronic pain disorder (e.g., fibromyalgia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria Grossi, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Connecticut Children's Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CT Children's Medical Center</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Connecticut Children's Medical Center</investigator_affiliation>
    <investigator_full_name>Victoria Grossi</investigator_full_name>
    <investigator_title>Pediatric Fellow/GI Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <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/NCT02984059
org study id: The ALLAY Study
nct id: NCT02984059
lead sponsor: 
has dmc: No
To characterize persistent abdominal pain in children with inflammatory bowel disease (IBD)
      by examining factors such as disease type, activity and location, psychosocial factors, and
      genetics.

      The investigators hypothesize that by using patient pain and psychological assessments in
      addition to analysis of blood, stool and colonic biopsies, we can better characterize factors
      that predispose children and adolescents with IBD to have persistent and/or disproportionate
      abdominal pain.
This is a prospective longitudinal inception cohort pilot study. The study will hopefully
      provide information about why there is persistent abdominal pain in children with IBD by
      examining factors such as disease type, activity and location, psychosocial factors, and
      genetics. Fifty newly diagnosed pediatric IBD patients, age 8-17 years will be enrolled into
      the study. There will be 2 control groups as well: pain control population: 20 patients with
      irritable bowel syndrome (IBS) or functional abdominal pain (FAP) diagnosis who have no
      evidence of bowel inflammation will serve as a pain control population for patients with no
      active inflammation. To serve as a control population for patients with no abdominal pain or
      inflammation, the investigators will include 10 patients with no gastrointestinal symptoms,
      who undergo colonoscopy for various reasons such as painless rectal bleeding, polyp
      surveillance, etc. The investigators anticipate completing enrollment in 12 months and
      allowed another 12 months for follow-up.

      The study participants will be seen every 3 months for a year and they will have the
      following procedures/test performed:

        1. Standard of care blood and stool samples

        2. Pediatric Ulcerative Colitis Activity Index (PUCAI) or Pediatric Crohn's Disease
           Activity Index (PCDAI)

      They will have an endoscopy performed at diagnosis then at 12 months from enrollment.

      A magnetic resonance enterography (MRE) will be done at diagnosis.

      The following pain and anxiety tests will be performed throughout the study:

      Pain:

      Pain Severity Duration Scale (PSDS) Pediatric Catastrophizing Scale-Child/Parents (PCS-C/P)
      Pain Burden Interview (PBI) Adolescent Pediatric Pain Tool (APPT)

      Anxiety:

      Revised Children's Anxiety and Depression Scale (RCADS-25) Children's Somatization Index
      (CSI-24) Adult Responses to Children's Symptoms (ARCS)

      Blood, rectal biopsies and stool specimens will be obtained throughout various time points of
      the study to look at hematology, sed rates, C-reactive protein, genomic DNA, colon RNA, stool
      microbiome and stool calprotectin.

      In summary, the investigators will be examining:

        1. Relationship between clinical factors and persistent abdominal pain in patients with IBD

             1. Disease type

             2. Location of disease at diagnosis

             3. Extent of disease at diagnosis

             4. Markers of inflammation at diagnosis and over the course of follow up

             5. Active disease vs. inactive disease over the course of follow up

        2. Relationship between psychosocial factors persistent abdominal pain, and remission
           status, specifically in patients with:

             1. Inactive IBD vs. active IBD

             2. Inactive IBD vs. IBS/FAP

             3. We will compare the parental report to patient report in the above mentioned groups

        3. Relationship between gene expression, microbiome, persistent abdominal pain, and
           remission status, specifically in patients with:

             1. Inactive IBD vs. active IBD

             2. Inactive IBD vs. IBS/FAP

             3. Inactive IBD vs. controls with no abdominal pain
observational model: Case-Control
time perspective: Prospective
measure: Changes in abdominal pain from baseline at 3, 6, 9, and 12 months will be assessed using questionnaires
time frame: Assessed at baseline then at months 3, 6, 9, and 12
description: Changes in abdominal pain from baseline then assessed again at 3, 6, 9, and 12 months.
arm group label: IBD w/abdominal pain
description: Patients with IBD with abdominal pain. Extra colonic biopsies for RNA analysis. If blood and stool samples are collected for standard of care:blood analyzed for both genomic DNA and calprotectin, and stool analyzed for microbiome. If no blood is drawn then a buccal swab done for the genomic DNA analysis and stool analyzed for calprotectin.
Pain questionnaires:
Pain Frequency-Severity-Duration Scale Pain Catastrophizing Scale-Child Version Pain Burden Interview Pediatric Quality of Life Inventory Adolescent Pediatric Pain Tool Anxiety/Depression Questionnaires Revised Children's Anxiety and Depression Scale Children's Somatization Inventory Adult Responses to Children's Symptoms
arm group label: IBD w/out abdominal pain
description: Patients with IBD and no abdominal pain. Colonoscopy done for standard of care, extra colonic biopsies for RNA analysis. If blood and stool samples are collected for standard of care:blood analyzed for genomic DNA and calprotectin and stool analyzed for microbiome. If no blood is drawn then a buccal swab for the genomic DNA analysis and stool analyzed for calprotectin.
Pain questionnaires:
Pain Frequency-Severity-Duration Scale Pain Catastrophizing Scale-Child Version Pain Burden Interview Pediatric Quality of Life Inventory Adolescent Pediatric Pain Tool Anxiety/Depression Questionnaires Revised Children's Anxiety and Depression Scale Children's Somatization Inventory Adult Responses to Children's Symptoms
arm group label: Colonoscopy other reasons no abd pain
description: Patients who have a colonoscopy for other reasons, rectal bleeding or polyp surveillance, no abdominal pain. Extra colonic biopsies for RNA analysis. If blood and stool samples are collected for standard of care:blood analyzed for genomic DNA and calprotectin and stool analyzed for microbiome. If no blood is drawn then a buccal swab for the genomic DNA analysis and stool analyzed for calprotectin.
intervention type: Genetic
intervention name: Genomic DNA
description: blood draw
arm group label: Colonoscopy other reasons no abd pain
arm group label: IBD w/abdominal pain
arm group label: IBD w/out abdominal pain
intervention type: Genetic
intervention name: RNA analysis
description: Mucosal Biopsy via colonoscopy
arm group label: Colonoscopy other reasons no abd pain
arm group label: IBD w/abdominal pain
arm group label: IBD w/out abdominal pain
intervention type: Genetic
intervention name: Microbiome
description: Stool microbiome
arm group label: Colonoscopy other reasons no abd pain
arm group label: IBD w/abdominal pain
arm group label: IBD w/out abdominal pain
intervention type: Other
intervention name: Calprotectin
description: stool or blood analysis for calprotectin
arm group label: Colonoscopy other reasons no abd pain
arm group label: IBD w/abdominal pain
arm group label: IBD w/out abdominal pain
intervention type: Other
intervention name: Pain questionnaires
description: PSDS PCS-C/P PBI APPT
arm group label: IBD w/abdominal pain
arm group label: IBD w/out abdominal pain
intervention type: Other
intervention name: Anxiety/Depression Questionnaires
description: RCADS-25 CSI-24 ARCS
arm group label: IBD w/abdominal pain
arm group label: IBD w/out abdominal pain
pending
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: No
last name: Victoria Grossi, DO
role: Principal Investigator
affiliation: Connecticut Children's Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Connecticut Children's Medical Center
investigator full name: Victoria Grossi
investigator title: Pediatric Fellow/GI Department
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Abdominal Pain
sharing ipd: No