Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori

Phase 4CompletedNCT02776371

Shandong University301 enrolled

Overview

Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

301

Conditions

Helicobacter Pylori Eradication Rate

Interventions

Modified non-clarithromycin triple therapyDRUG

H. pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.

Sequential therapyDRUG

H. pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who were intend to undergo upper endoscopy for any purpose and volunteered to written inform consent. Exclusion Criteria: * negative in rapid urease test (RUT) * previous standard eradication therapy for H. pylori; * history of esophagectomy or gastrectomy; * gastrointestinal malignancy; * contraindications or allergic to study drugs; * user of taking medicine that may affect the result of the study within 4 weeks (e.g., proton-pump inhibitors, H2-receptor antagonists, bismuth or antibiotics etc.); * cardiopulmonary, hepatic or renal insufficiency, and/or severe current diseases or malignancy; * pregnant or lactating women; * participants of other trial within the past 3 months; * unwilling or unable to participate in the study.

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

the difference of eradication rates between 2 groups

Time frame: 5 months

Secondary Outcomes

the different rates of adverse events between 2 groups

Time frame: 5 months

Data from ClinicalTrials.gov

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