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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06015763
Other study ID # H.pylori and gastritis
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2023
Est. completion date December 2024

Study information

Verified date August 2023
Source Assiut University
Contact Merna Mawgoud
Phone 01282213004
Email mernamawgoud@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2
Est. completion date December 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Endoscopy
Endoscopic biopsy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merna Mawgoud Zaki Bechit

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between H.pylori colonization and severity of gastritis. Biopsy will be taken to correlate between severity of gastritis and colonization of H.pylori. Baseline
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