A Comparison of High-dose Dual Therapy and Half-dose Clarithromycin-containing Bismuth Quadruple Therapy for H.P Eradication in Elderly Patients

The purpose of this study is to assess and compare the effectiveness and safety of high-dose dual therapy and half-dose clarithromycin-containing bismuth quadruple therapy in elderly patients for eradicating H.pylori.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori
• Intervention / Treatment: Drug: Lansoprazole, Amoxicillin; Drug: Lansoprazole, Amoxicillin,Clarithromycin and Bismuth subcitrate

Detailed Description

Helicobacter pylori plays an important role in many diseases such as peptic ulcer disease and MALT lymphomas. And the prevalence of H. pylori remains high in developing countries,including China.

Clarithromycin-containing bismuth quadruple therapy has been recommended as the first-line therapy for H pylori infection in China. However, its expensive cost and high antibiotic-related adverse reactions are always haunting us. In 2018,a research from NanFang hospital(China）revealed that 250mg clarithromycin is as effective as 500mg clarithromycin，at the same time，causes less adverse reactions. On the othe hand,previous studies reported a new regimen called large dose dual therapy（generally contains a PPI and amoxicillin),while some of them have achieved very good results,especially in Taiwan.

However, specific data on anti-H.pylori treatments in elderly people are very lacking.So,we aim to assess and compare the effectiveness and tolerability of high-dose dual therapy and half-dose clarithromycin-containing bismuth quadruple therapy in elderly patients.Considering the difference of drug metabolism between eldery and young people，a satisfactory result may be obtained.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 257000
      • Qilu hosipital
      • Sub-Investigator: Boshen Lin, MD
      • Sub-Investigator: Yueyue Li, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients, aged greater than 65 , with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

• Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high dose dual group; Patients in high dose dual group will receive lansoprazole (Takepron) 30mg po qid, amoxicillin 750mg po qid for 14d	Drug: Lansoprazole, Amoxicillin; high dose dual regimen
Active Comparator: half-dose clarithromycin-containing bismuth quadruple group; Patients in half-dose clarithromycin-containing bismuth quadruple group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and clarithromycin (Klacid) 250mg po bid for 14d	Drug: Lansoprazole, Amoxicillin,Clarithromycin and Bismuth subcitrate; half-dose clarithromycin-containing bismuth quadruple regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
eradication rate of the two groups	24 months

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2019
• Primary Completion (Anticipated): September 20, 2021
• Study Completion (Anticipated): September 20, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: elderly,helicobacter pylori eradication,dual therapy,half-dose clarithromycin
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Antacids; Dexlansoprazole; Lansoprazole; Amoxicillin; Clarithromycin; Bismuth; Bismuth tripotassium dicitrate
• Other Study ID Numbers: 2019SDU-QILU-G099

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No