Ignite Creation Date:
2024-05-05 @ 11:11 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01278901
Status:
UNKNOWN
Last Update Posted:
2011-01-19
First Post:
2011-01-16
Brief Title:
The Effect of PPI Therapy on the Result of Helicobacter Pylori Diagnostic Tests
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2011-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
STUDY PROTOCOL
The study will include 30 patients ages 18-80y that had a gastroscopy for various reasons The patients should not be on PPI therapy If during the gastroscopy there are some pathologies that require a second look endoscopy after some weeks of therapy ulcers or esophagitis the investigators will repeat the gastroscopy within a month
During the first gastroscopy a biopsy will be taken for histological examination and for a rapid urease test and an urea breath test will be done soon after the procedure
If one of the tests is positive the investigators postulate that the Helicobacter pylori is actually present
After the gastroscopy the patient is given a full dose of PPI as indicated and helicobacter tests are repeated in the next endoscopy under PPI therapy Any positive test that become negative in the second endoscopy is considered false negative
The study will include 30 patients ages 18-80y that had a gastroscopy for various reasons The patients should not be on PPI therapy If during the gastroscopy there are some pathologies that require a second look endoscopy after some weeks of therapy ulcers or esophagitis the investigators will repeat the gastroscopy within a month
During the first gastroscopy a biopsy will be taken for histological examination and for a rapid urease test and an urea breath test will be done soon after the procedure
If one of the tests is positive the investigators postulate that the Helicobacter pylori is actually present
After the gastroscopy the patient is given a full dose of PPI as indicated and helicobacter tests are repeated in the next endoscopy under PPI therapy Any positive test that become negative in the second endoscopy is considered false negative
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None