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Pepsinogens as the Early Marker of H. Pylori Eradication

Primary Purpose

H. Pylori Infection, Gastric Ulcer, Duodnal Ulcer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
serum pepsinogen
urea breath test
Sponsored by
Hamamatsu University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for H. Pylori Infection

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with H. pylori infection Exclusion Criteria: Patients without H. pylori infection

Sites / Locations

  • Hamamatsu University School of Medicine

Outcomes

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.

Full Information

First Posted
September 12, 2005
Last Updated
January 31, 2006
Sponsor
Hamamatsu University
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1. Study Identification

Unique Protocol Identification Number
NCT00197457
Brief Title
Pepsinogens as the Early Marker of H. Pylori Eradication
Official Title
Serum Pepsinogens as an Early Diagnostic Marker of H. Pylori Eradication
Study Type
Interventional

2. Study Status

Record Verification Date
May 2001
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hamamatsu University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
H. Pylori Infection, Gastric Ulcer, Duodnal Ulcer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
serum pepsinogen
Intervention Type
Procedure
Intervention Name(s)
urea breath test
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Cost-effectiveness for diagnosis of H. pylori eradication by the serum pepsinogen.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with H. pylori infection Exclusion Criteria: Patients without H. pylori infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naohito Shirai, MD., PhD.
Organizational Affiliation
Hamamatsu University
Official's Role
Study Chair
Facility Information:
Facility Name
Hamamatsu University School of Medicine
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan

12. IPD Sharing Statement

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Pepsinogens as the Early Marker of H. Pylori Eradication

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