Study of Levofloxacin-based Concomitant Therapy for H. Pylori Eradication in Diabetic Patients

Chung-Tai Wu114 enrolled

Overview

The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel 10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Helicobacter Pylori Infection

Interventions

PantoprazoleDRUG

H. pylori eradication therapy

AmoxicillinDRUG

H. pylori eradication therapy

MetronidazoleDRUG

H. pylori eradication therapy

Levofloxacin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetic patients with Helicobacter pylori infection Exclusion Criteria: * Pregnancy or physically poor performance status * Patients with contraindication for upper endoscopy * Severe coagulopathy for endoscopic biopsy * Chronic kidney disease (eGFR \< 50) or end stage renal disease * Known allergy to interventional drugs * Previous eradication failure

Outcomes

Primary Outcomes

Helicobacter pylori eradication rate

C13-UBT to confirm the H. pylori eradication

Time frame: 1-4 months after eradication therapy

Secondary Outcomes

Acute inflammatory score

Gastric tissue obtained from antrum (2 pieces), body (2 pieces) and cardia (1 piece) were scoring by modified Sydney system and specific staining. Acute inflammatory score (AIS) can be assessed by the sum of these five pathologic tissues