Intraluminal Mono-antibiotic Therapy for Helicobacter Pylori Infection - A Comparison of Levofloxacin Powder and Levofloxacin Solution

Summary

Helicobacter pylori (H. pylori) is an important causal factor of chronic gastritis, peptic ulcer disease, gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above diagnosis for patient with H. pylori infection. The eradication of H. pylori can reduce the recurrence rate of peptic ulcer disease and even has the potential to prevent gastric cancer. H. pylori is the most common chronic bacterial infection in humans. The prevalence of H. pylori is about 30-50% in the Western adult population. It is estimated that about 50% of people are infected with this bacterium in Taiwan.

Triple therapy which contains a proton pump inhibitor and two antibiotics among clarithromycin, amoxicillin, and metronidazole is the most commonly used regimen for H. pylori eradication. The treatment duration is 7 to 14 days. However, the eradication rate of standard triple therapy has fallen below 80% in many countries due to the worldwide increasing prevalence of antibiotic resistant strains.

Several strategies have been proposed to increase the eradication rate in the first line therapy or as a rescue therapy, including extending the treatment duration to 14 days, increasing the doses of antibiotics, the use of four or even five drugs regimen (sequential, concomitant, quadruple or quintuple therapy), and other antibiotics such as levofloxacin. However, these therapies may increase the side effects and costs of treatment, decrease the compliance of patients and increase the rate of worldwide antibiotic resistance steadily. The WHO has listed H. Pylori as one of 16 antibiotic-resistant bacteria that have the greatest threat to human health in February, 2017.

The most commonly used oral antibiotics for the treatment of H. pylori are Amoxicillin、Clarithromycin、Metronidazole、Levofloxacin and Tetracycline.

However, with the increasing rates of antibiotic-resistance for Clarithromycin and Metronidazole, the Clarithromycin and Metronidazole were replaced by Levofloxacin as a first line or second line treatment in some area. However, the eradication rate of Levofloxacin-containing triple therapy is suboptimal in many countries. The investigators aim to compare the efficacy of different formulation between Levofloxacin Powder and Levofloxacin Solution in the Intraluminal levofloxacin therapy, and to improve the eradication efficacy of one-week Levofloxacin-containing triple therapy via the Intraluminal therapy.

Conditions

• Helicobacter Pylori Infection

Interventions

DRUG

Levofloxacin film-coated tablet

50 participants are randomly assigned to receive intraluminal eradication of H. pylori. with medicaments containing levofloxacin powder or levofloxacin solution.

DRUG

Levofloxacin intravenous solution

50 participants are randomly assigned to receive intraluminal eradication of H. pylori. with medicaments containing levofloxacin powder or levofloxacin solution.

Sponsors & Collaborators

• Mackay Memorial Hospital

  lead OTHER

Principal Investigators

• Tai-cherng Liou, MD · Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-14

Primary Completion

2020-07-01

Completion

2020-12-27

Countries

• Taiwan

Study Locations