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Correlation Between H.Pylori Colonization and Gastritis

Primary Purpose

Gastritis H Pylori

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopy
Sponsored by
Merna Mawgoud Zaki Bechit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastritis H Pylori

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - All patients with gastritis above 18 years old with chronic H.pylori infection documented by histological examination included in the study. Exclusion Criteria: All patients mentioned above who have previous gastrointestinal surgery and patients below 18y .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Relation between gastritis and H.pylori

    Arm Description

    Endoscopic

    Outcomes

    Primary Outcome Measures

    Correlation between H.pylori colonization and severity of gastritis.
    Biopsy will be taken to correlate between severity of gastritis and colonization of H.pylori.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 23, 2023
    Last Updated
    August 23, 2023
    Sponsor
    Merna Mawgoud Zaki Bechit
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06015763
    Brief Title
    Correlation Between H.Pylori Colonization and Gastritis
    Official Title
    Correlation Between H.Pylori Colonization and Severity of Gastritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Merna Mawgoud Zaki Bechit

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastritis H Pylori

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Endoscopic
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Relation between gastritis and H.pylori
    Arm Type
    Other
    Arm Description
    Endoscopic
    Intervention Type
    Procedure
    Intervention Name(s)
    Endoscopy
    Intervention Description
    Endoscopic biopsy
    Primary Outcome Measure Information:
    Title
    Correlation between H.pylori colonization and severity of gastritis.
    Description
    Biopsy will be taken to correlate between severity of gastritis and colonization of H.pylori.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - All patients with gastritis above 18 years old with chronic H.pylori infection documented by histological examination included in the study. Exclusion Criteria: All patients mentioned above who have previous gastrointestinal surgery and patients below 18y .
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Merna Mawgoud
    Phone
    01282213004
    Email
    mernamawgoud@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fatema Abu-Bakr
    Phone
    01006564000

    12. IPD Sharing Statement

    Learn more about this trial

    Correlation Between H.Pylori Colonization and Gastritis

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