Pepsinogens as the Early Marker of H. Pylori Eradication

This study has been completed.
Sponsor:
Information provided by:
Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00197457
First received: September 12, 2005
Last updated: January 31, 2006
Last verified: May 2001
  Purpose

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 Intervention Phase
H. Pylori Infection
Gastric Ulcer
Duodnal Ulcer
Procedure: serum pepsinogen
Procedure: urea breath test
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Serum Pepsinogens as an Early Diagnostic Marker of H. Pylori Eradication

Resource links provided by NLM:


Further study details as provided by Hamamatsu University:

Primary Outcome Measures:
  • 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:
  • Cost-effectiveness for diagnosis of H. pylori eradication by the serum pepsinogen.

Study Start Date: June 2001
  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with H. pylori infection

Exclusion Criteria:

  • Patients without H. pylori infection
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00197457

Locations
Japan
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan, 431-3192
Sponsors and Collaborators
Hamamatsu University
Investigators
Study Chair: Naohito Shirai, MD., PhD. Hamamatsu University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00197457     History of Changes
Other Study ID Numbers: pepsinogen2005
Study First Received: September 12, 2005
Last Updated: January 31, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Helicobacter Infections
Pathologic Processes
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 22, 2014