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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01906879
• Other study ID #: 201304017MINB
• Status: Recruiting
• Phase: Phase 4
• First received: July 21, 2013
• Last updated: June 9, 2017
• Start date: June 2013
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: National Taiwan University Hospital
• Contact: Jyh-Ming Liou, MD, PhD
• Email: dtmed046[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1620
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• triple, quadruple, non-bismuth quadruple therapy
triple therapy, quadruple therapy, non-bismuth quadruple therapy

Locations

Country	Name	City	State
Taiwan	Chiayi Christian Hospital	Chiayi
Taiwan	National Taiwan University Hospital, Hsinchu Branch	Hsinchu
Taiwan	E- DA Hospital and I-Shou University	Kaohsiung
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	Mackay Memorial Hospital, Taipei	Taipei
Taiwan	Ming-Shiang Wu	Taipei
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Mackay Memorial Hospital, Taitung	Taitung
Taiwan	National Taiwan University Hospital, Yun-Lin Branch	Yun-Lin County

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reinfection rate	Eradication rates in the second line treatment in the three treatment groups; Overall eradication rates after first line and second line treatment in the three treatment groups; Antibiotic resistance of gut flora after first line and second line treatments in the three treatment groups; Changes of gut microbiota in the three treatment groups; Re-infection rate one year after eradication therapy	1 year
Primary	Eradication rate for H. pylori	Eradication rate in the first line according to intention to treat (ITT) and per-protocol (PP) analysis in the three treatment groups	6 weeks
Secondary	Adverse effects of each treatments	(1) Incidence of adverse effects in the first line therapy in the three treatment groups	2 weeks