Helicobacter Pylori Infection Clinical Trial
Official title:
Comparison of Rapid Urease Test Between the Gastric Body and Antrum in Helicobacter Pylori-Infected Stomach
| Verified date | April 2017 |
| Source | Soonchunhyang University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The accurate diagnosis of H. pylori infection is an important step for establishing the strategy for gastric cancer prevention. During endoscopy, rapid urease test (RUT) is the first of biopsy-based H. pylori tests. Despite indirect test for H. pylori detection, RUT shows rapid result with good sensitivity and specificity. Several study reported that H. pylori density was related to positive reaction time of RUT. However, there was no study comparing the positive reaction times of RUT according to biopsy site, degree of gastric atrophy, and intestinal metaplasia.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Subjects who underwent upper endoscopy and rapid urease test Exclusion Criteria: - : age < 20 or > 70 years; anemia (serum hemoglobin level < 10 g/dL); severe systemic disease or advanced chronic liver disease; use of certain medications, including proton pump inhibitors, H2-receptor antagonists, or antibiotics; a history of H. pylori eradication; a history of gastric surgery; a recent history of upper gastrointestinal bleeding. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Digestive Disease Center, Soonchunhyang University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Soonchunhyang University Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Positive reaction time of urease test | Color change to red or pink means positivity | within 24 hours |
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