xml: <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/NCT06015763</url>
    </required_header>
    <id_info>
      <org_study_id>H.pylori and gastritis</org_study_id>
      <nct_id>NCT06015763</nct_id>
    </id_info>
    <brief_title>Correlation Between H.Pylori Colonization and Gastritis</brief_title>
    <official_title>Correlation Between H.Pylori Colonization and Severity of Gastritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Merna Mawgoud Zaki Bechit</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut 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>
        To study the prevelance rate of H.pylori colonization in patients with gastritis.&#xD;
  &#xD;
        To correlate the H.pylori colonization with endoscopic finding. To correlate both H.pylori&#xD;
        colonization and endoscopic finding with clinical manifestation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Helicobacter pylori is a gram negative microaerophilic spiral bacterium that is usually found&#xD;
        in the stomach and thereby cause infection , which is associated with varying degrees of&#xD;
        damage of superficial and glandular epithelium.&#xD;
  &#xD;
        Chronic gastritis is a histological entity that is defined by an inflammatory infiltrate of&#xD;
        lymphoblasma cells, cocsometimes polynuclear neutrophils and by progressive glandular atrophy&#xD;
        of the gastric mucosa,and probably the main cause of chronic inflammation in the gastric&#xD;
        mucosa which is usually caused by H.pylori infection.&#xD;
  &#xD;
        In addition to chronic gastritis almost all benign gastroduodenal diseases including peptic&#xD;
        ulcer , mucosa associated lymphoid tissue lymphoma and malignant gastroduodenal&#xD;
        adenocarcinoma occurs due to previous H.pylori infection that is usually started with gastric&#xD;
        precancerous lesion, gastric atrophy , gastric intestinal metaplasia , dysplasia and then&#xD;
        turned to gastric carcinoma.&#xD;
  &#xD;
        So the evaluation of H.pylori infection status yo non-infection, past infection, current&#xD;
        infection by endoscopy has therefore become increasingly important.&#xD;
  &#xD;
        The Sydney grading system is one of the most important recognised tools yo charactize&#xD;
        histological lesions of chronic gastritis.&#xD;
  &#xD;
        The system categorise gastritis according to intensity of mononuclear inflammatory cellular&#xD;
        infiltrate , polymorph activity , atrophy , intestinal metaplasia and H.pylori density into&#xD;
        mild , moderate and severe categories, but up till now there is non-standard histology&#xD;
        reporting formats are still widely used for gastritis and even specialists are often&#xD;
        frustrated by the histological definition that make it difficult to identify candidates for&#xD;
        clinico-endoscopic surveillance.&#xD;
  &#xD;
        Therefore the eradication of this bacterium aimed to interrupt the carcinogenesis process and&#xD;
        prevent recurrence of gastritis and peptic ulcer disease.&#xD;
  &#xD;
        However despite of the significant researches conducted on H.pylori colonization in gastric&#xD;
        mucosa and its association with endoscopic finding and severity of clinical manifestations,&#xD;
        and its impact on the Egyptian population is still a topic of debate.&#xD;
  &#xD;
        Currently, there is no study has definitively determined this relationship in the Egyptian&#xD;
        population despite the high prevalence rate of H.pylori infection&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Endoscopic</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Correlation between H.pylori colonization and severity of gastritis.</measure>
      <time_frame>Baseline</time_frame>
      <description>Biopsy will be taken to correlate between severity of gastritis and colonization of H.pylori.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">2</enrollment>
    <condition>Gastritis H Pylori</condition>
    <arm_group>
      <arm_group_label>Relation between gastritis and H.pylori</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Endoscopic</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endoscopy</intervention_name>
      <description>Endoscopic biopsy</description>
      <arm_group_label>Relation between gastritis and H.pylori</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - All patients with gastritis above 18 years old with chronic H.pylori infection documented&#xD;
          by histological examination included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          All patients mentioned above who have previous gastrointestinal surgery and patients below&#xD;
          18y .&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Merna Mawgoud</last_name>
      <phone>01282213004</phone>
      <email>mernamawgoud@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fatema Abu-Bakr</last_name>
      <phone>01006564000</phone>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Merna Mawgoud Zaki Bechit</investigator_full_name>
      <investigator_title>Relation between H.pylori colonization and severity of gastritis</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastritis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015763
  org study id: H.pylori and gastritis
  nct id: NCT06015763
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To study the prevelance rate of H.pylori colonization in patients with gastritis.
  
        To correlate the H.pylori colonization with endoscopic finding. To correlate both H.pylori
        colonization and endoscopic finding with clinical manifestation.
  Helicobacter pylori is a gram negative microaerophilic spiral bacterium that is usually found
        in the stomach and thereby cause infection , which is associated with varying degrees of
        damage of superficial and glandular epithelium.
  
        Chronic gastritis is a histological entity that is defined by an inflammatory infiltrate of
        lymphoblasma cells, cocsometimes polynuclear neutrophils and by progressive glandular atrophy
        of the gastric mucosa,and probably the main cause of chronic inflammation in the gastric
        mucosa which is usually caused by H.pylori infection.
  
        In addition to chronic gastritis almost all benign gastroduodenal diseases including peptic
        ulcer , mucosa associated lymphoid tissue lymphoma and malignant gastroduodenal
        adenocarcinoma occurs due to previous H.pylori infection that is usually started with gastric
        precancerous lesion, gastric atrophy , gastric intestinal metaplasia , dysplasia and then
        turned to gastric carcinoma.
  
        So the evaluation of H.pylori infection status yo non-infection, past infection, current
        infection by endoscopy has therefore become increasingly important.
  
        The Sydney grading system is one of the most important recognised tools yo charactize
        histological lesions of chronic gastritis.
  
        The system categorise gastritis according to intensity of mononuclear inflammatory cellular
        infiltrate , polymorph activity , atrophy , intestinal metaplasia and H.pylori density into
        mild , moderate and severe categories, but up till now there is non-standard histology
        reporting formats are still widely used for gastritis and even specialists are often
        frustrated by the histological definition that make it difficult to identify candidates for
        clinico-endoscopic surveillance.
  
        Therefore the eradication of this bacterium aimed to interrupt the carcinogenesis process and
        prevent recurrence of gastritis and peptic ulcer disease.
  
        However despite of the significant researches conducted on H.pylori colonization in gastric
        mucosa and its association with endoscopic finding and severity of clinical manifestations,
        and its impact on the Egyptian population is still a topic of debate.
  
        Currently, there is no study has definitively determined this relationship in the Egyptian
        population despite the high prevalence rate of H.pylori infection
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Endoscopic
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Correlation between H.pylori colonization and severity of gastritis.
  time frame: Baseline
  description: Biopsy will be taken to correlate between severity of gastritis and colonization of H.pylori.
  arm group label: Relation between gastritis and H.pylori
  arm group type: Other
  description: Endoscopic
  intervention type: Procedure
  intervention name: Endoscopy
  description: Endoscopic biopsy
  arm group label: Relation between gastritis and H.pylori
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Merna Mawgoud
  phone: 01282213004
  email: mernamawgoud@gmail.com
  last name: Fatema Abu-Bakr
  phone: 01006564000
  responsible party type: Sponsor-Investigator
  investigator affiliation: Assiut University
  investigator full name: Merna Mawgoud Zaki Bechit
  investigator title: Relation between H.pylori colonization and severity of gastritis
  mesh term: Gastritis