Pepsinogens as the Early Marker of H. Pylori Eradication

NCT00197457 | Completed Phase 2

• 1 other identifier: pepsinogen2005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

H. Pylori Infection; Gastric Ulcer; Duodnal Ulcer

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Cost-effectiveness for diagnosis of H. pylori eradication by the serum pepsinogen.

Interventions

serum pepsinogen PROCEDURE

urea breath test PROCEDURE

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with H. pylori infection

You may not qualify if:

• Patients without H. pylori infection

Sponsors & Collaborators

• Hamamatsu University: lead

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

Location

MeSH Terms

Conditions

Stomach Ulcer

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Naohito Shirai, MD., PhD.

  Hamamatsu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2001
• Last Updated: February 1, 2006

Record last verified: 2001-05

Locations

JP (1)