A comparative study of sequential therapy and 10-day standard triple therapy for Helicobacter pylori infectio

Phase 3

Completed

• Conditions: Eradication of Helicobacter pylori infection; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Infection - Other infectious diseases

• Registration Number: ACTRN12613000377730
• Lead Sponsor: Sanren Lin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Consecutive patients with dyspepsia who had been referred for upper endoscopy at four tertiary hospitals in Beijing, Shanghai, Wuhan and Guangzhou were included in the study. Patients with positive Helicobacter pylori cultures were recruited into the study. None of the patients had previously received treatment for Helicobacter pylori infection.

Exclusion Criteria

Patients who had received proton pump inhibitor, H2-receptor blockers, bismuth salts or antibiotics in the previous 4 weeks were excluded from entering the study. None of the patients had a history of gastrointestinal malignancy, previous gastric or esophageal surgery, Zollinger-Ellison syndrome, severe concomitant cardiovascular, respiratory, hematological, renal, hepatic or neurological diseases. Women who were pregnant or lactating were excluded from the study, as were those known to be allergic to any of the study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eradication rates (%) of Helicobacter pylori infection associated with sequential therapy and 10-d standard triple therapy.<br>Patients with peptic ulcer and macroscopic gastric mucosal erosions underwent repeat upper endoscopy to determine the outcome of eradication therapy after treatment. Three gastric biopsies were taken at this visit: one from the antrum for rapid urease test and one each from the antrum and corpus for Warthin-Starry staining. Helicobacter pylori infection eradication was defined by the demonstration of a negative rapid urease test and a negative Warthin-Starry stain. <br>A urea breath test was used to confirm Helicobacter pylori infection status for patients without evidence of peptic ulcer or macroscopic gastric mucosal erosions after treatment. Helicobacter pylori infection was considered to be eradicated if the urea breath test result was negative.[At 8 to 12 weeks after treatment (participants are assessed once only)]