Pepsinogens as the Early Marker of H. Pylori Eradication

• Sponsor: Hamamatsu University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00197457
• Collaborator: (none)
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
H. Pylori Infection; Gastric Ulcer; Duodnal Ulcer	Procedure: serum pepsinogen; Procedure: urea breath test	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Serum Pepsinogens as an Early Diagnostic Marker of H. Pylori Eradication
• Study Start Date: Jun 1, 2001

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Cost-effectiveness for diagnosis of H. pylori eradication by the serum pepsinogen. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with H. pylori infection

Exclusion Criteria:

• Patients without H. pylori infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka	Japan	431-3192

Sponsors and Collaborators

• Hamamatsu University

Investigators

• Study Chair: Naohito Shirai, MD., PhD., Hamamatsu University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00197457
• Other Study ID Numbers: pepsinogen2005
• First Posted: Sep 20, 2005
• Last Update Posted: Feb 1, 2006
• Last Verified: May 1, 2001

• Additional relevant MeSH terms: Stomach Ulcer; Ulcer

Study Results

No Results Posted as of Feb 1, 2006