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NCT00197457 Clinical Trial

Pepsinogens as the Early Marker of H. Pylori Eradication

Gastric Ulcer Clinical Trial

Official title:
Serum Pepsinogens as an Early Diagnostic Marker of H. Pylori Eradication

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00197457
Other study ID # pepsinogen2005
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated January 31, 2006
Start date June 2001

Study information
Verified date May 2001
Source Hamamatsu University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

Helicobacter pylori (H. pylori) eradication increases the serum pepsinogen (PG) I/PG II ratio and the percentage change in PG I/PG II ratios was found to be a useful marker of H. pylori eradication (e.g., the PG method). We studied whether the PG method could be an early diagnostic marker of H. pylori eradication even in patients persistently treated with a proton pump inhibitor. Sixty-two H. pylori-positive patients underwent H. pylori-eradication therapy, followed by treatment with a PPI to cure ulcers. Serum levels of PG I and PG II were measured before, at the end of, and at 4 weeks after the eradication therapy. At more than one month after the end of treatments, 13C-urea breath test (UBT) was performed. The cut-off values of percentage changes in PG I/PG II ratios for the diagnosis of eradication of H. pylori were set in proportion to PG I/PG II ratios before eradication in accordance with our previous report. Using the results of UBT as the standard, the percentage change in serum PG I/PG II ratios is useful as an early diagnostic marker for judgment of H. pylori eradication irrespective of PPI treatment.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients with H. pylori infection

Exclusion Criteria:

- Patients without H. pylori infection

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• serum pepsinogen

• urea breath test

Locations
Country Name City State
Japan Hamamatsu University School of Medicine Hamamatsu Shizuoka

Sponsors (1)
Lead Sponsor Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Whether the serum pepsinogen could be an early diagnostic marker of H. pylori eradication even in patients persistently treated with a proton pump inhibitor compared with 13C-urea breath test.
Secondary Cost-effectiveness for diagnosis of H. pylori eradication by the serum pepsinogen.
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