<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/NCT03259659</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00095405</org_study_id>
    <nct_id>NCT03259659</nct_id>
  </id_info>
  <brief_title>Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis</brief_title>
  <official_title>Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To prove that patients with ulcerative proctitis and proctosigmoiditis have impaired&#xD;
           autonomic functions, i.e. increased sympathetic activity and/or reduced vagal tone.&#xD;
&#xD;
        2. To demonstrate inflammatory cytokine imbalance, i.e., increased pro-inflammatory&#xD;
           cytokines. Presence of these abnormalities would make patients with ulcerative proctitis&#xD;
           and proctosigmoiditis good candidates for future sacral nerve stimulation therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Principal Investigator was leaving the institution.&#xD;
  </why_stopped>
  <start_date type="Actual">November 30, 2017</start_date>
  <completion_date type="Actual">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">February 29, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>symptoms characteristics in ulcerative colitis patients</measure>
    <time_frame>1 day</time_frame>
    <description>ulcerative colitis disease activity index will be assessed using the Mayo scoring system, which includes stool frequency, rectal bleeding, mucosal appearance at endoscopy and physician rating of disease activity. The patient will get a score from 0 to 20, with higher score indicating more severe disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>autonomic profile characteristics in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>heart rate variability indicating sympathetic and parasympathetic activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Granulocyte-colony stimulating factor (G-CSF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Eotaxin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Granulocyte-macrophage colony-stimulating factor (GM-CSF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, interleukin (IL) -1α</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Leptin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Macrophage Inflammatory Proteins (MIP) -1α</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, interleukin (IL) -4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, interleukin (IL) -1β</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, interleukin (IL) -2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, interleukin (IL) -6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Epidermal growth factor (EGF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, interleukin (IL) -13</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, interleukin (IL) -10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, interleukin (IL) -12p70</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Interferon gamma (IFNγ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, interleukin (IL) -5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, interleukin (IL) -17A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, interleukin (IL) -18</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Monocyte Chemoattractant Protein-1 (MCP-1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Interferon - induced protein 10 (IP-10),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, growth regulated oncogene (GRO)/Keratinocyte chemoattractant KC/cytokine-induced neutrophil chemoattractant (CINC)-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Vascular endothelial growth factor (VEGF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Fractalkine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Lipopolysaccharide-induced CXC chemokine (LIX)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Macrophage Inflammatory Proteins (MIP) -2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, Tumor necrosis factor (TNF) α</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory cytokine profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>blood sample, RANTES (Regulated on Activation, Normal T Cell Expressed and Secreted)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microbiota profile in ulcerative colitis patients and healthy controls</measure>
    <time_frame>1 day</time_frame>
    <description>fecal sample microbiota analysis</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>irritable bowel disease patient</arm_group_label>
    <description>Patients with ulcerative proctitis and proctosigmoiditis who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy control</arm_group_label>
    <description>Healthy participates who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index</intervention_name>
    <description>In this study, an electrocardiogram signal will be recorded for 30 min in the fasting state, and blood samples for inflammatory cytokines analysis (7 ml) will be taken at the end of the ECG recording; fecal samples will be taken on the experimental day before the study. In addition, ulcerative colitis disease activity index will be assessed using the Mayo scoring system.</description>
    <arm_group_label>healthy control</arm_group_label>
    <arm_group_label>irritable bowel disease patient</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood sample for inflammatory cytokines, fecal sample for microbiota&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        irritable bowel disease patients and healthy controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No any systemic diseases;&#xD;
&#xD;
          -  no proctitis or proctosigmoiditis;&#xD;
&#xD;
          -  no history of gastrointestinal surgery;&#xD;
&#xD;
          -  no symptoms of diarrhea or fecal urgency during the past 2 weeks;&#xD;
&#xD;
          -  not taking any medications except contraceptives during the past 2 weeks;&#xD;
&#xD;
          -  age 18-65.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiande Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Proctitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03259659
org study id: IRB00095405
nct id: NCT03259659
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
1. To prove that patients with ulcerative proctitis and proctosigmoiditis have impaired
           autonomic functions, i.e. increased sympathetic activity and/or reduced vagal tone.

        2. To demonstrate inflammatory cytokine imbalance, i.e., increased pro-inflammatory
           cytokines. Presence of these abnormalities would make patients with ulcerative proctitis
           and proctosigmoiditis good candidates for future sacral nerve stimulation therapy.
observational model: Case-Control
time perspective: Prospective
measure: symptoms characteristics in ulcerative colitis patients
time frame: 1 day
description: ulcerative colitis disease activity index will be assessed using the Mayo scoring system, which includes stool frequency, rectal bleeding, mucosal appearance at endoscopy and physician rating of disease activity. The patient will get a score from 0 to 20, with higher score indicating more severe disease.
measure: autonomic profile characteristics in ulcerative colitis patients and healthy controls
time frame: 1 day
description: heart rate variability indicating sympathetic and parasympathetic activity
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Granulocyte-colony stimulating factor (G-CSF)
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Eotaxin
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Granulocyte-macrophage colony-stimulating factor (GM-CSF)
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, interleukin (IL) -1α
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Leptin
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Macrophage Inflammatory Proteins (MIP) -1α
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, interleukin (IL) -4
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, interleukin (IL) -1β
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, interleukin (IL) -2
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, interleukin (IL) -6
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Epidermal growth factor (EGF)
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, interleukin (IL) -13
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, interleukin (IL) -10
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, interleukin (IL) -12p70
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Interferon gamma (IFNγ)
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, interleukin (IL) -5
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, interleukin (IL) -17A
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, interleukin (IL) -18
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Monocyte Chemoattractant Protein-1 (MCP-1)
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Interferon - induced protein 10 (IP-10),
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, growth regulated oncogene (GRO)/Keratinocyte chemoattractant KC/cytokine-induced neutrophil chemoattractant (CINC)-1
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Vascular endothelial growth factor (VEGF)
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Fractalkine
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Lipopolysaccharide-induced CXC chemokine (LIX)
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Macrophage Inflammatory Proteins (MIP) -2
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, Tumor necrosis factor (TNF) α
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: blood sample, RANTES (Regulated on Activation, Normal T Cell Expressed and Secreted)
measure: microbiota profile in ulcerative colitis patients and healthy controls
time frame: 1 day
description: fecal sample microbiota analysis
arm group label: irritable bowel disease patient
description: Patients with ulcerative proctitis and proctosigmoiditis who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.
arm group label: healthy control
description: Healthy participates who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.
intervention type: Other
intervention name: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index
description: In this study, an electrocardiogram signal will be recorded for 30 min in the fasting state, and blood samples for inflammatory cytokines analysis (7 ml) will be taken at the end of the ECG recording; fecal samples will be taken on the experimental day before the study. In addition, ulcerative colitis disease activity index will be assessed using the Mayo scoring system.
arm group label: healthy control
arm group label: irritable bowel disease patient
blood sample for inflammatory cytokines, fecal sample for microbiota
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jiande Chen, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Inflammatory Bowel Diseases
mesh term: Proctitis
sharing ipd: Undecided