NCT03156855

Sequential Therapy Versus Quadruple Therapy in H. Pylori Eradication

Comparison of the Efficacy of Sequential Therapy and Bismuth Quadruple Therapy in the First Line and Second Line Therapy for Helicobacter Pylori Infection- A Multi-center Randomized Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 620 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

The investigators aimed to 1. compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the first line and second line treatment 2. assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens 3. assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora 4. assess the impact of eradication therapy on the metabolic factors

Detailed description

Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection reduces the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. Sequential therapy for 10 days has been shown to be more effective than triple therapy for 7 and 10 days. The investigators further demonstrated that sequential therapy given for 14 days was superior to triple therapy given for 14 days. Recently, the investigators also found that bismuth quadruple therapy given for 10 days appeared to be more effective than triple therapy given for 14 days in the first line therapy. However, whether sequential therapy given for 14 days is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown.

Conditions

• Helicobacter

Interventions

Type	Name	Description
DRUG	14-day sequential therapy	D1-D7: (esomeprazole 40mg qid + amoxicillin 500mg qid) for 7 days D8-D14: (esomeprazole 40mg qid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days
DRUG	Bismuth quadruple therapy	D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2017-05-17
• Last updated: 2017-05-17

Locations

7 sites across 1 country: Taiwan