Pepsinogens as the Early Marker of H. Pylori Eradication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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H. Pylori Infection Gastric Ulcer Duodnal Ulcer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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serum pepsinogen

Intervention Type PROCEDURE

urea breath test

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with H. pylori infection

Exclusion Criteria

* Patients without H. pylori infection

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Naohito Shirai, MD., PhD.

Role: STUDY_CHAIR

Hamamatsu University

Locations

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Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, Japan

Site Status

Countries

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Japan

Other Identifiers

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pepsinogen2005

Identifier Type: -

Identifier Source: org_study_id