Comparison of Two Novel First-line Anti-Helicobacter Pylori Therapy

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Nexium; Drug: Amolin; Drug: Klaricid; Drug: Flagyl

• Registration Number: NCT03383003
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The Asian-Pacific Consensus Report has recommended that proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. As a general rule for the treatment of other infectious diseases, clinicians should prescribe therapeutic regimens that have a per-protocol eradication rate ≥ 90% for anti-H pylori therapy. However, the eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently. The reasons for this fall in efficacy with time may relate to the increasing incidence of clarithromycin-resistant strains of H. pylori. Clarithromycin resistance is the major cause of eradication failure for stand triple therapy. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20% because the per-protocol eradication rates of standard therapies are often less than 85% and the intention-to-treat eradication rates are usually less than 80%..7-10 day non-bismuth containing quadruple therapy (Concomitant therapy) had been successful in the presence of clarithromycin resistance. Another novel treatment with 14-day high dose PPI and amoxicilin dual therapy could also attained \>90 eradication rate in some studies. This novel treatment is simple and involved only two drugs and the most important of all is that amoxicillin resistance is still 0% in Taiwan . High dose PPI has been used in several studies for H. pylori eradication in order to increase the intra-gastric PH for optimal eradication So far, there is still unclear which one is the best first-line H. pylori eradication regimen with highest eradication rate and least adverse effects. We therefore design a randomized controlled trial to simultaneously assess the efficacy novel 14-day high dose dual therapy by comparing to the 7-day non-bismuth containing quadruple therapy in Taiwan and to investigate the host and bacterial factors predicting the treatment outcomes of eradication therapies.

Detailed Description

The Asian-Pacific Consensus Report has recommended that proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. As a general rule for the treatment of other infectious diseases, clinicians should prescribe therapeutic regimens that have a per-protocol eradication rate ≥ 90% for anti-H pylori therapy. However, the eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently.\[3-9\] The reasons for this fall in efficacy with time may relate to the increasing incidence of clarithromycin-resistant strains of H. pylori. The main reasons for eradication failure for H pylori infection include antibiotic resistance, poor compliance and rapid metabolism of PPI. Clarithromycin resistance is the major cause of eradication failure for stand triple therapy. The rate of clarithromycin-resistant strains ranged from 49% (Spain) to 1% (Netherland) worldwide. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20% because the per-protocol eradication rates of standard therapies are often less than 85% and the intention-to-treat eradication rates are usually less than 80%. 7-10 day non-bismuth containing quadruple therapy (Concomitant therapy) had been successful in the presence of clarithromycin resistance. Another novel treatment with 14-day high dose PPI and amoxicilin dual therapy could also attained \>90 eradication rate in some studies. This novel treatment is simple and involved only two drugs and the most important of all is that amoxicillin resistance is still 0% in Taiwan. High dose PPI has been used in several studies for H. pylori eradication in order to increase the intra-gastric PH for optimal eradication So far, there is still unclear which one is the best first-line H. pylori eradication regimen with highest eradication rate and least adverse effects. We therefore design a randomized controlled trial to simultaneously assess the efficacy novel 14-day high dose dual therapy by comparing to the 7-day non-bismuth containing quadruple therapy in Taiwan and to investigate the host and bacterial factors predicting the treatment outcomes of eradication therapies.

Study Timeline

• Study Start: 2016-03-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-17
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-26
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. H. pylori-infected outpatients with endoscopically proven peptic ulcer diseases or gastritis.

Exclusion Criteria

1. Previous H. pylori-eradication therapy
2. ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
3. patients with allergic history to the medications used
4. patients with previous gastric surgery
5. the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
6. pregnant women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose dual therapy	Amolin	Esomeprezole (Nexium)40 mg tid. and amoxicillin (Amolin) 750 mg qid. for 14 days
Non-bismuth quadruple therapy	Amolin	Esomeprezole (Nexium) 40 mg bid.,clarithromycin (Klaricid) 500 mg bid., amoxicillin (Amolin) 1 g bid. and metronidazole (Flagyl) 500 mg bid. for 7 days
Non-bismuth quadruple therapy	Klaricid	Esomeprezole (Nexium) 40 mg bid.,clarithromycin (Klaricid) 500 mg bid., amoxicillin (Amolin) 1 g bid. and metronidazole (Flagyl) 500 mg bid. for 7 days
High dose dual therapy	Nexium	Esomeprezole (Nexium)40 mg tid. and amoxicillin (Amolin) 750 mg qid. for 14 days
Non-bismuth quadruple therapy	Nexium	Esomeprezole (Nexium) 40 mg bid.,clarithromycin (Klaricid) 500 mg bid., amoxicillin (Amolin) 1 g bid. and metronidazole (Flagyl) 500 mg bid. for 7 days
Non-bismuth quadruple therapy	Flagyl	Esomeprezole (Nexium) 40 mg bid.,clarithromycin (Klaricid) 500 mg bid., amoxicillin (Amolin) 1 g bid. and metronidazole (Flagyl) 500 mg bid. for 7 days

Primary Outcome Measures

Name	Time	Method
The rates of H.pylori eradication	6-8 weeks after treatment	The primary outcome variables were the rates of eradication. Chi-square test with or without Yates correction for continuity and Fisher's exact test were used when appropriate to compare the major outcomes between groups. A P value less than 0.05 was considered statistically significant.

Trial Locations

Locations (1)

Wei-Chen Tai; 🇨🇳 Kaohsiung, Taiwan