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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03156855
Enrollment
620
Registered
2017-05-17
Start date
2015-09-30
Completion date
2019-12-31
Last updated
2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter

Keywords

efficacy, safety, H. pylori eradication

Brief 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.

Interventions

DRUG14-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

D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days

Sponsors

E-DA Hospital
CollaboratorOTHER
National Taiwan University Hospital Hsin-Chu Branch
CollaboratorOTHER
Taipei Veterans General Hospital, Taiwan
CollaboratorOTHER_GOV
Kaohsiung Medical University
CollaboratorOTHER
Chiayi Christian Hospital
CollaboratorOTHER
Mackay Memorial Hospital
CollaboratorOTHER
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1\. H. pylori infected patients naïve to eradication therapies will be eligible in this study.

Exclusion criteria

1. children and teenagers aged less than 20 years, 2. history of gastrectomy, 3. gastric malignancy, including adenocarcinoma and lymphoma, 4. previous allergic reaction to antibiotics (bismuth, amoxicillin, metronidazole, clarithromycin, tetracycline) and PPI (esomeprazole), 5. contraindication to treatment drugs, 6. pregnant or lactating women, 7. severe concurrent disease, 8. concomitant use of clopidogrel, or (9) Unwilling to accept random assignment of subjects

Design outcomes

Primary

MeasureTime frameDescription
Eradication rate: determined by urea breath test (13C-UBT, according to ITT analysis)6 weeksNo eradicated divided by total cases by intention to treat analysis. 13C-UBT will be used to determine the H. pylori status at least 6 weeks after completion of treatment. A delta value of \> 4 units will be defined as positive for H. pylori infection as our previous studies.

Secondary

MeasureTime frameDescription
changes of antibiotic resistance2 weeks, 8 weeks, 1 yearchanges of antibiotic resistance of E. coli by per protocol analysis
adverse effect: occurrence of any adverse effect during the treatment2 weeksadverse effects related to treatment by per protocol analysis. The patients will be informed of the common side effects from the studied drugs prior to therapy. They will also be asked to record these symptoms during treatment. A standardized interview at the outpatient clinic at the end of treatment will be arranged. The adverse events and compliance will be assessed by the research staffs with pre-defined case report form.

Other

MeasureTime frameDescription
changes of gut microbiota2 weeks, 8 weeks, 1 yearchanges of gut microbiota before and after HP eradication by per protocol analysis

Countries

Taiwan

Contacts

Primary ContactJyh-Ming Liou, MD, PhD
dtmed046@pchome.com.tw

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026