Skip to content

Triple Therapy Versus Quadruple Therapies in the First Line Therapy of Helicobacter Pylori Infection

Comparison of the Efficacy of Clarithromycin-based Triple Therapy Versus Quadruple Therapies in the First Line Therapy of Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01906879
Enrollment
1620
Registered
2013-07-24
Start date
2013-06-30
Completion date
2017-12-31
Last updated
2017-06-12

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

Conditions

Helicobacter Pylori Infection

Brief summary

Whether non-bismuth quadruple therapy (concomitant therapy) is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown. Therefore, we aim to compare the eradication rates and long term re-infection rates of quadruple therapy for 10 days versus non-bismuth quadruple therapy for 10 days vs. triple therapy for 14 days. Methods: This will be a multi-center, open labeled, randomized control trial Patients: H. pylori infected patients who have willingness to receive eradication therapy Testing for H. pylori infection Before First Line Ttreatment (1)Any two positive of rapid urease test, histology, serology and culture or a positive UBT will be considered as H. pylori infected After First Line Treatment: C13-Urea breath test will be used to assess the existence of H. pylori 6-8 weeks after first line therapy. Long term reinfection: C13- Urea breath test will be used to assess the recurrence of H. pylori 1 year after eradication therapy

Detailed description

First line therapy: open labeled, randomized control trial, randomized into one of the three groups Group (A): triple therapy for 14 days D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid Group (B): non-bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + amoxicillin 1gm bid + clarithromycin 500mg bid + metronidazole 500mg bid Group (C): bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid Second line therapy: patients who fail from first line treatment will be rescue with the following treatment Group (A) Patient who fail from triple therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid Group (B) Patient who fail from non-bismuth quadruple therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid Group (C) Patients who fail from bismuth quadruple therapy will be retreated with non-bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + amoxicillin 1gm bid + clarithromycin 500mg bid + metronidazole 500mg bid

Interventions

DRUGtriple, quadruple, non-bismuth quadruple therapy

triple therapy, quadruple therapy, non-bismuth quadruple therapy

Sponsors

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

Patients aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrolment. Written informed consents will be obtained from all patients prior to enrollment.

Exclusion criteria

Patients will be excluded from the study if any one of the following criteria is present: (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 (amoxicillin, clarithromycin, metronidazole, or levofloxacin) and prompt pump inhibitors (lansoprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent diseases, and (8) Patients who cannot give informed consent by himself or herself.

Design outcomes

Primary

MeasureTime frameDescription
Eradication rate for H. pylori6 weeksEradication rate in the first line according to intention to treat (ITT) and per-protocol (PP) analysis in the three treatment groups

Secondary

MeasureTime frameDescription
Adverse effects of each treatments2 weeks(1) Incidence of adverse effects in the first line therapy in the three treatment groups

Other

MeasureTime frameDescription
Reinfection rate1 year1. Eradication rates in the second line treatment in the three treatment groups 2. Overall eradication rates after first line and second line treatment in the three treatment groups 3. Antibiotic resistance of gut flora after first line and second line treatments in the three treatment groups 4. Changes of gut microbiota in the three treatment groups 5. Re-infection rate one year after eradication therapy

Countries

Taiwan

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026