<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/NCT03820284</url>
  </required_header>
  <id_info>
    <org_study_id>L23457</org_study_id>
    <nct_id>NCT03820284</nct_id>
  </id_info>
  <brief_title>Association Between Helicobacter Pylori and Inflammatory Bowel Disease</brief_title>
  <official_title>Association Between Helicobacter Pylori and Inflammatory Bowel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Introduction:&#xD;
&#xD;
      Helicobacter pylori has been linked to a variety of gastric and extra gastric diseases.&#xD;
      Chronic infection with H. pylori causes histologically evident gastritis in all colonized&#xD;
      individuals and is the predominant risk factor for gastric and duodenal ulcers as well as&#xD;
      gastric adenocarcinoma. However, increasingly robust experimental and epidemiological&#xD;
      evidence suggests that H. pylori may at the same time be beneficial to its carriers, as it&#xD;
      efficiently prevents allergic disorders and chronic inflammatory conditions .&#xD;
&#xD;
      Inflammatory bowel disease (IBD) is characterized by chronic, nonspecific intestinal&#xD;
      inflammation with an unexplained pathology and an alternating relapsing and remitting&#xD;
      clinical progression. IBD is divided into two subtypes: ulcerative colitis (UC) and Crohn's&#xD;
      disease (CD). Most studies in the IBD field attribute its etiology to the complex&#xD;
      interactions among immune dysfunction, genetic susceptibility of the host, and environmental&#xD;
      risk factors.&#xD;
&#xD;
      Since the twenty-first century, improving hygienic conditions and socioeconomic status have&#xD;
      reduced the H. pylori infection rate and this trend has concurrently been accompanied by an&#xD;
      increased IBD incidence in most countries Numerous studies have reported a lower H. pylori&#xD;
      infection rate in patients with CD and/or UC than in non-IBD control individuals. although a&#xD;
      small number of studies showed no significant association .Recently, emerging epidemiologic&#xD;
      studies and animal experiments revealed an inverse correlation between H. pylori infection&#xD;
      and IBD onset, suggesting that H. pylori colonization exerts a special protective effect on&#xD;
      autoimmune diseases&#xD;
&#xD;
      observation Cross sectional study will be conducted at assuit university hospitals on all&#xD;
      patients with inflammatory disease to detect the prevalence of helicobacter pylori among them&#xD;
      .Then the examined patients will be divided in to two group receiving the same medication&#xD;
      group A : inflammatory bowel disease patient with H.PYLORI group B: inflammatory bowel&#xD;
      disease Patient without H.PYLORI longitudinal study will be conducted to both group to study&#xD;
      the clinical outcomes in both group .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PATIENT AND METHOD :&#xD;
&#xD;
      observation Cross sectional study will be conducted at assuit university hospitals on all&#xD;
      patients with inflammatory disease to detect the prevalence of helicobacter pylori among them&#xD;
      .Then the examined patients will be divided in to two group receiving the same medication&#xD;
      group A : inflammatory bowel disease patient with H.PYLORI group B: inflammatory bowel&#xD;
      disease Patient without H.PYLORI longitudinal study will be conducted to both group to study&#xD;
      the clinical outcomes in both group .&#xD;
&#xD;
        1. Thorough medical history and full clinical examination will be taken from all patient&#xD;
           including&#xD;
&#xD;
           -Personal history focus on special habit especially smoking&#xD;
&#xD;
           -documented previous history for H.pylori eradication&#xD;
&#xD;
             -  Onset and duration of inflammatory bowel disease&#xD;
&#xD;
             -  current medication&#xD;
&#xD;
             -  presence of any extra intestinal manifestation of Inflammatory bowel disease&#xD;
&#xD;
             -  presence of any complications from Inflammatory bowel disease&#xD;
&#xD;
        2. Investigation :&#xD;
&#xD;
           -All patients with inflammatory bowel disease will be tested for presence or absence of&#xD;
           H.PYLORI by histological examination of endoscopically biopsied gastric mucosa&#xD;
&#xD;
           -his to logical examination of colonic mucosal every 3 months&#xD;
&#xD;
           -complete blood count&#xD;
&#xD;
           -serum albumin&#xD;
&#xD;
           -c reactive protein, erythrocyte sedimentation rate (ESR).&#xD;
&#xD;
           -fecal calprotectin if possible&#xD;
&#xD;
             -  assess the severity of among both group (A,B) every 3 month for 2years. ulcerative&#xD;
                by Mayo Score/Ulcerative Colitis Disease Activity Index and Crohn's disease by&#xD;
                Montreal classifications for Crohn's Disease .&#xD;
&#xD;
           Mayo Score/Ulcerative Colitis Disease Activity Stool frequency 0 = Normal 1 = 1-2&#xD;
           stools/day more than normal 2 = 3-4 stools/day more than normal 3 = 4 stools/day more&#xD;
           than normal Rectal bleeding 0 = None 1 = Visible blood with stool less than half the&#xD;
           time 2 = Visible blood with stool half of the time or more 3 = Passing blood alone&#xD;
           Mucosal appearance at endoscopy 0 = Normal or inactive disease 1 = Mild disease&#xD;
           (erythema, decreased vascular pattern, mild friability) 2 = Moderate disease (marked&#xD;
           erythema, absent vascular pattern, friability, erosions) 3 = Severe disease (spontaneous&#xD;
           bleeding, ulceration) Physician rating of disease activity 0 = Normal 1 = Mild 2 =&#xD;
           Moderate 3 = Severe&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</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>prevalance of H.pylori among patients with inflammatory bowel disease</measure>
    <time_frame>One years</time_frame>
    <description>Number of patient with inflammatory bowel disease with H.pylori infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mayo score activity index among ulcerative colitis patients with H.pylori and without H.pylori</measure>
    <time_frame>Two years</time_frame>
    <description>Stool frequency 0 = Normal 1 = 1-2 stools/day more than normal 2 = 3-4 stools/day more than normal 3 = 4 stools/day more than normal Rectal bleeding 0 = None 1 = Visible blood with stool less than half the time 2 = Visible blood with stool half of the time or more 3 = Passing blood alone Mucosal appearance at endoscopy 0 = Normal or inactive disease 1 = Mild disease (erythema, decreased vascular pattern, mild friability) 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions) 3 = Severe disease (spontaneous bleeding, ulceration) Physician rating of disease activity 0 = Normal 1 = Mild 2 = Moderate 3 = Severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mucosal healing among inflammatory bowel disease with H.pylori and without H.pylori</measure>
    <time_frame>1years</time_frame>
    <description>Histological examination of the biopsied colonic mucosal every 3 months in both groups</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Helicobacter Infections</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Group A inflammatory bowel disease with helicobacter pylori infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>Inflammatory bowel disease without helicobacter pylori infection</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Inflammatory bowel disease patients with or without H.pylori infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all inflammatory bowel disease at assiut university will be included and examined in&#xD;
             cross sectional study for detection of presence of H.pylori in one year 2019-2020&#xD;
             .then the examined patients will be divided in two group A ,B according to presence or&#xD;
             absence of H pylori . Both group will be studied in cohort study for two years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  -patients with history of administration of proton pump inhibitor or antibiotics with&#xD;
             in eight weeks .&#xD;
&#xD;
          -  patients with history of recent upper gastrointestinal bleeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bahaa Os Taha, Master of internal medicine</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zain elabdeen Ah Sayed, Doctorate of internal medicine</last_name>
    <role>Study Director</role>
    <affiliation>Assiut</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alaa El Abdelmonem, Doctorate of internal medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bahaa osman taha</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>June 29, 2021</last_update_submitted>
  <last_update_submitted_qc>June 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Bahaa osman taha</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Helicobacter Infections</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03820284
org study id: L23457
nct id: NCT03820284
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction:

      Helicobacter pylori has been linked to a variety of gastric and extra gastric diseases.
      Chronic infection with H. pylori causes histologically evident gastritis in all colonized
      individuals and is the predominant risk factor for gastric and duodenal ulcers as well as
      gastric adenocarcinoma. However, increasingly robust experimental and epidemiological
      evidence suggests that H. pylori may at the same time be beneficial to its carriers, as it
      efficiently prevents allergic disorders and chronic inflammatory conditions .

      Inflammatory bowel disease (IBD) is characterized by chronic, nonspecific intestinal
      inflammation with an unexplained pathology and an alternating relapsing and remitting
      clinical progression. IBD is divided into two subtypes: ulcerative colitis (UC) and Crohn's
      disease (CD). Most studies in the IBD field attribute its etiology to the complex
      interactions among immune dysfunction, genetic susceptibility of the host, and environmental
      risk factors.

      Since the twenty-first century, improving hygienic conditions and socioeconomic status have
      reduced the H. pylori infection rate and this trend has concurrently been accompanied by an
      increased IBD incidence in most countries Numerous studies have reported a lower H. pylori
      infection rate in patients with CD and/or UC than in non-IBD control individuals. although a
      small number of studies showed no significant association .Recently, emerging epidemiologic
      studies and animal experiments revealed an inverse correlation between H. pylori infection
      and IBD onset, suggesting that H. pylori colonization exerts a special protective effect on
      autoimmune diseases

      observation Cross sectional study will be conducted at assuit university hospitals on all
      patients with inflammatory disease to detect the prevalence of helicobacter pylori among them
      .Then the examined patients will be divided in to two group receiving the same medication
      group A : inflammatory bowel disease patient with H.PYLORI group B: inflammatory bowel
      disease Patient without H.PYLORI longitudinal study will be conducted to both group to study
      the clinical outcomes in both group .
PATIENT AND METHOD :

      observation Cross sectional study will be conducted at assuit university hospitals on all
      patients with inflammatory disease to detect the prevalence of helicobacter pylori among them
      .Then the examined patients will be divided in to two group receiving the same medication
      group A : inflammatory bowel disease patient with H.PYLORI group B: inflammatory bowel
      disease Patient without H.PYLORI longitudinal study will be conducted to both group to study
      the clinical outcomes in both group .

        1. Thorough medical history and full clinical examination will be taken from all patient
           including

           -Personal history focus on special habit especially smoking

           -documented previous history for H.pylori eradication

             -  Onset and duration of inflammatory bowel disease

             -  current medication

             -  presence of any extra intestinal manifestation of Inflammatory bowel disease

             -  presence of any complications from Inflammatory bowel disease

        2. Investigation :

           -All patients with inflammatory bowel disease will be tested for presence or absence of
           H.PYLORI by histological examination of endoscopically biopsied gastric mucosa

           -his to logical examination of colonic mucosal every 3 months

           -complete blood count

           -serum albumin

           -c reactive protein, erythrocyte sedimentation rate (ESR).

           -fecal calprotectin if possible

             -  assess the severity of among both group (A,B) every 3 month for 2years. ulcerative
                by Mayo Score/Ulcerative Colitis Disease Activity Index and Crohn's disease by
                Montreal classifications for Crohn's Disease .

           Mayo Score/Ulcerative Colitis Disease Activity Stool frequency 0 = Normal 1 = 1-2
           stools/day more than normal 2 = 3-4 stools/day more than normal 3 = 4 stools/day more
           than normal Rectal bleeding 0 = None 1 = Visible blood with stool less than half the
           time 2 = Visible blood with stool half of the time or more 3 = Passing blood alone
           Mucosal appearance at endoscopy 0 = Normal or inactive disease 1 = Mild disease
           (erythema, decreased vascular pattern, mild friability) 2 = Moderate disease (marked
           erythema, absent vascular pattern, friability, erosions) 3 = Severe disease (spontaneous
           bleeding, ulceration) Physician rating of disease activity 0 = Normal 1 = Mild 2 =
           Moderate 3 = Severe
observational model: Cohort
time perspective: Prospective
measure: prevalance of H.pylori among patients with inflammatory bowel disease
time frame: One years
description: Number of patient with inflammatory bowel disease with H.pylori infection
measure: Mayo score activity index among ulcerative colitis patients with H.pylori and without H.pylori
time frame: Two years
description: Stool frequency 0 = Normal 1 = 1-2 stools/day more than normal 2 = 3-4 stools/day more than normal 3 = 4 stools/day more than normal Rectal bleeding 0 = None 1 = Visible blood with stool less than half the time 2 = Visible blood with stool half of the time or more 3 = Passing blood alone Mucosal appearance at endoscopy 0 = Normal or inactive disease 1 = Mild disease (erythema, decreased vascular pattern, mild friability) 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions) 3 = Severe disease (spontaneous bleeding, ulceration) Physician rating of disease activity 0 = Normal 1 = Mild 2 = Moderate 3 = Severe
measure: Mucosal healing among inflammatory bowel disease with H.pylori and without H.pylori
time frame: 1years
description: Histological examination of the biopsied colonic mucosal every 3 months in both groups
arm group label: Group A
description: Group A inflammatory bowel disease with helicobacter pylori infection
arm group label: Group B
description: Inflammatory bowel disease without helicobacter pylori infection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bahaa Os Taha, Master of internal medicine
role: Principal Investigator
affiliation: Assiut University
last name: Zain elabdeen Ah Sayed, Doctorate of internal medicine
role: Study Director
affiliation: Assiut
last name: Alaa El Abdelmonem, Doctorate of internal medicine
role: Study Chair
affiliation: Assiut University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Bahaa osman taha
investigator title: Principal investigator
mesh term: Helicobacter Infections
mesh term: Inflammatory Bowel Diseases