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

Sponsor

Shandong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04101708

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori	Drug: Lansoprazole, Amoxicillin Drug: Lansoprazole, Amoxicillin,Clarithromycin and Bismuth subcitrate	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 20, 2019

Anticipated Primary Completion Date :

Sep 20, 2021

Anticipated Study Completion Date :

Sep 20, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

eradication rate of the two groups [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.