<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/NCT03026582</url>
  </required_header>
  <id_info>
    <org_study_id>SchneiderCMCIsrael</org_study_id>
    <nct_id>NCT03026582</nct_id>
  </id_info>
  <brief_title>Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease</brief_title>
  <acronym>SPIBDUS</acronym>
  <official_title>Intestinal Ultrasound Role in the Management of Pediatric Inflammatory Bowel Disease: A Prospective Longitudinal Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schneider Children's Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schneider Children's Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: To assess the predictive value of IUS in children with IBD.&#xD;
&#xD;
      Design: A prospective longitudinal cohort study.&#xD;
&#xD;
      Setting: Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's&#xD;
      Hospital.&#xD;
&#xD;
      Participants: Children 2 years to 17 years (up to 200 patients) who have been diagnosed with&#xD;
      either CD or UC.&#xD;
&#xD;
      Main outcome measures: The changes in bowel wall thickness, assessed by IUS, during 2-year&#xD;
      follow-up according to therapeutic regimen.&#xD;
&#xD;
      Secondary outcome measures: Correlation of sonographic measures to clinical disease indices,&#xD;
      serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and other&#xD;
      radiologic measures performed as part of routine care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis:&#xD;
&#xD;
      The investigators hypothesize that bowel wall thickness as measured routinely by IUS has a&#xD;
      role in predicting short- and long-term disease outcomes such as flares, hospitalizations,&#xD;
      treatment escalation and surgery.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary Objectives:&#xD;
&#xD;
      To assess the changes in bowel wall thickness, assessed by IUS, during 2-year follow-up,&#xD;
      according to therapeutic regimen and to evaluate its predictive significance on disease&#xD;
      outcomes (flares, hospitalizations, treatment escalation and surgery).&#xD;
&#xD;
      Secondary Objective: To evaluate the correlation of sonographic measures to clinical disease&#xD;
      indices, serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and&#xD;
      other radiologic measures performed as part of routine care.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
        -  Design: A prospective longitudinal cohort study.&#xD;
&#xD;
        -  Patients: Children at age 2 year to 17 years diagnosed with IBD.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      Children diagnosed with either CD or UC under follow-up at the Institute of Gastroenterology,&#xD;
      Nutrition and Liver Diseases, Schneider Children's Hospital, will be enrolled. Patients can&#xD;
      be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics&#xD;
      will be retrieved from their medical files including demographic details, disease phenotype,&#xD;
      endoscopic and radiologic variables, anthropometric measures, laboratory evaluation,&#xD;
      complication and therapeutic regimens. At enrollment and every 3 months for a total period of&#xD;
      2 years all patients will perform IUS during regular clinic visits. All other measures&#xD;
      including laboratory exams, anthropometric measurements and disease activity indices (either&#xD;
      wPCDAI for CD or PUCAI for UC) will be performed as part of standard of care and not for the&#xD;
      purpose of the study. If endoscopic evaluation or an MRE are necessary according to the&#xD;
      treating physician discretion for assessment of disease activity, these will not be performed&#xD;
      as part of the study but the results will be recorded and included in the data analysis.&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      Data will be analyzed using SPSS (version 23.0, SPSS, Inc., Armonk, NY, USA) and r-project&#xD;
      version 3.1.1. Continues variables will be presented as either mean±SD or median with&#xD;
      interquartile range (IQR) depending on the data approximation to normal distribution.&#xD;
      Agreement between IUS and MRE (when available) will be assessed using Bland-Altman plot and&#xD;
      Concurrent Validity quantified by correlation coefficient and concordance correlation&#xD;
      coefficient. Associations of therapeutic intervention and other variables with outcome&#xD;
      measures will be examined using repeated measures ANOVA. p-values &lt;0.05 is considered&#xD;
      significant.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      All pediatric IBD patients at Schneider Children's Hospital, fulfilling the inclusion&#xD;
      criteria are eligible for the study. For assessment of therapeutic interventions of IUS the&#xD;
      investigators will use mixed model ANOVA. Sample size was calculated for repeated measures&#xD;
      ANOVA with in-between interactions. Assuming effect size F 0.25 (or partial η2=0.06), an&#xD;
      alpha of 5% and statistical power of 80% and a correlation of 0.5, the investigators will&#xD;
      need at least 34 CD patients and 34 UC patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in bowel wall thickness according to therapeutic regimen</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in bowel wall thickness in comparison to inflammatory markers</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bowel wall thickness in comparison to fecal calprotectin</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bowel wall thickness in comparison to pediatric Crohn's disease severity index in Crohn's disease</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bowel wall thickness in comparison to pediatric ulcerative colitis activity index in ulcerative colitis</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intestinal ultra-sound monitoring</intervention_name>
    <description>Children diagnosed with either CD or UC will be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, endoscopic and radiologic variables, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. At enrollment and every 3 months for a total period of 2 years all patients will perform intestinal US during regular clinic visits. All other measures including laboratory exams, anthropometric measurements and disease activity indices (either PCDAI for CD or PUCAI for UC) will be performed as part of standard of care.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children 2 years to 17 years who have been diagnosed at the Schneider Children's Hospital&#xD;
        with either Crohn's disease or ulcerative colitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of IBD&#xD;
&#xD;
          2. Age: 2- 17 years (inclusive)&#xD;
&#xD;
          3. Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. Morbid obesity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amit Assa</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schneider Children's Medical Center, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schenider Children's Medical Center</name>
      <address>
        <city>Petaẖ Tiqwa</city>
        <zip>4920235</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schneider Children's Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Amit Assa</investigator_full_name>
    <investigator_title>Head of IBD program</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>
  </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/NCT03026582
org study id: SchneiderCMCIsrael
nct id: NCT03026582
lead sponsor: 
has dmc: Yes
Objectives: To assess the predictive value of IUS in children with IBD.

      Design: A prospective longitudinal cohort study.

      Setting: Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's
      Hospital.

      Participants: Children 2 years to 17 years (up to 200 patients) who have been diagnosed with
      either CD or UC.

      Main outcome measures: The changes in bowel wall thickness, assessed by IUS, during 2-year
      follow-up according to therapeutic regimen.

      Secondary outcome measures: Correlation of sonographic measures to clinical disease indices,
      serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and other
      radiologic measures performed as part of routine care.
Hypothesis:

      The investigators hypothesize that bowel wall thickness as measured routinely by IUS has a
      role in predicting short- and long-term disease outcomes such as flares, hospitalizations,
      treatment escalation and surgery.

      Objectives:

      Primary Objectives:

      To assess the changes in bowel wall thickness, assessed by IUS, during 2-year follow-up,
      according to therapeutic regimen and to evaluate its predictive significance on disease
      outcomes (flares, hospitalizations, treatment escalation and surgery).

      Secondary Objective: To evaluate the correlation of sonographic measures to clinical disease
      indices, serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and
      other radiologic measures performed as part of routine care.

      Methods:

        -  Design: A prospective longitudinal cohort study.

        -  Patients: Children at age 2 year to 17 years diagnosed with IBD.

      Intervention:

      Children diagnosed with either CD or UC under follow-up at the Institute of Gastroenterology,
      Nutrition and Liver Diseases, Schneider Children's Hospital, will be enrolled. Patients can
      be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics
      will be retrieved from their medical files including demographic details, disease phenotype,
      endoscopic and radiologic variables, anthropometric measures, laboratory evaluation,
      complication and therapeutic regimens. At enrollment and every 3 months for a total period of
      2 years all patients will perform IUS during regular clinic visits. All other measures
      including laboratory exams, anthropometric measurements and disease activity indices (either
      wPCDAI for CD or PUCAI for UC) will be performed as part of standard of care and not for the
      purpose of the study. If endoscopic evaluation or an MRE are necessary according to the
      treating physician discretion for assessment of disease activity, these will not be performed
      as part of the study but the results will be recorded and included in the data analysis.

      Data analysis:

      Data will be analyzed using SPSS (version 23.0, SPSS, Inc., Armonk, NY, USA) and r-project
      version 3.1.1. Continues variables will be presented as either mean±SD or median with
      interquartile range (IQR) depending on the data approximation to normal distribution.
      Agreement between IUS and MRE (when available) will be assessed using Bland-Altman plot and
      Concurrent Validity quantified by correlation coefficient and concordance correlation
      coefficient. Associations of therapeutic intervention and other variables with outcome
      measures will be examined using repeated measures ANOVA. p-values <0.05 is considered
      significant.

      Sample size:

      All pediatric IBD patients at Schneider Children's Hospital, fulfilling the inclusion
      criteria are eligible for the study. For assessment of therapeutic interventions of IUS the
      investigators will use mixed model ANOVA. Sample size was calculated for repeated measures
      ANOVA with in-between interactions. Assuming effect size F 0.25 (or partial η2=0.06), an
      alpha of 5% and statistical power of 80% and a correlation of 0.5, the investigators will
      need at least 34 CD patients and 34 UC patients.
observational model: Cohort
time perspective: Prospective
measure: Change in bowel wall thickness according to therapeutic regimen
time frame: Two years
measure: Change in bowel wall thickness in comparison to inflammatory markers
time frame: Two years
measure: Change in bowel wall thickness in comparison to fecal calprotectin
time frame: Two years
measure: Change in bowel wall thickness in comparison to pediatric Crohn's disease severity index in Crohn's disease
time frame: Two years
measure: Change in bowel wall thickness in comparison to pediatric ulcerative colitis activity index in ulcerative colitis
time frame: Two years
intervention type: Device
intervention name: Intestinal ultra-sound monitoring
description: Children diagnosed with either CD or UC will be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, endoscopic and radiologic variables, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. At enrollment and every 3 months for a total period of 2 years all patients will perform intestinal US during regular clinic visits. All other measures including laboratory exams, anthropometric measurements and disease activity indices (either PCDAI for CD or PUCAI for UC) will be performed as part of standard of care.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Amit Assa
role: Principal Investigator
affiliation: Schneider Children's Medical Center, Israel
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Schneider Children's Medical Center, Israel
investigator full name: Amit Assa
investigator title: Head of IBD program
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: No