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
About this trial
This is an interventional diagnostic trial for Gastritis H Pylori
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 .
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
NCT ID
NCT06015763
First Posted
August 23, 2023
Last Updated
August 23, 2023
Sponsor
Merna Mawgoud Zaki Bechit
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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