- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06015763
Correlation Between H.Pylori Colonization and Gastritis
Correlation Between H.Pylori Colonization and Severity of Gastritis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Merna Mawgoud
- Phone Number: 01282213004
- Email: mernamawgoud@gmail.com
Study Contact Backup
- Name: Fatema Abu-Bakr
- Phone Number: 01006564000
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Relation between gastritis and H.pylori
Endoscopic
|
Endoscopic biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between H.pylori colonization and severity of gastritis.
Time Frame: Baseline
|
Biopsy will be taken to correlate between severity of gastritis and colonization of H.pylori.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H.pylori and gastritis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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