We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pepsinogens as the Early Marker of H. Pylori Eradication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00197457
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 1, 2006
Sponsor:
Information provided by:

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  (Clinical Trial)
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 : June 2001
Arms and Interventions


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with H. pylori infection

Exclusion Criteria:

  • Patients without H. pylori infection
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00197457     History of Changes
Other Study ID Numbers: pepsinogen2005
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: February 1, 2006
Last Verified: May 2001

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases