NCT03524833

Intraluminal Metronidazole Powder Monotherapy for Helicobacter Pylori Infection

Completed Phase 4 Last updated 15 February 2019

What this trial tests

Phase 4 trial testing Metronidazole in Helicobacter Pylori Infection in 20 participants. Completed in 8 February 2019.

Timeline

7 May 2018

Primary endpoint
8 January 2019

8 February 2019

Quick facts

Lead sponsor	Mackay Memorial Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	7 May 2018
Primary completion	8 January 2019
Estimated completion	8 February 2019
Sites	1 location across Taiwan

Drugs / interventions tested

• Metronidazole (METRONIDAZOLE) — full drug profile →
• Lansoprazole, Amoxicillin, Metronidazole — full drug profile →

Conditions studied

• Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →

Sponsor

Mackay Memorial Hospital

Who can join

Adults 20 to 75, any sex, with Helicobacter Pylori Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Helicobacter pylori (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. Many studies have shown that 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. Eradication of H. pylori infection reduces the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. Several strategies have been proposed to overcome the declining eradication rate, including (1) extending the treatment duration of triple therapy to 14 days; (2) the use of bismuth quadruple therapy which contains bismuth, a proton pump inhibitor, and two antibiotics (usually metronidazole and tetracycline); (3) non-bismuth quadruple therapy (concomitant therapy) which contains a proton pump inhibitor and three antibiotics (usually amoxicillin, metronidazole, and clarithromycin); (4) sequential therapy which contains a proton pump inhibitor (PPI) plus amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another five days. The investigators aim to evaluate the efficacy of Metronidazole powder in the Intraluminal therapy for Helicobacter pylori infection while an endoscopic examination is performed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Factors Affecting the Intraluminal Therapy for <i>Helicobacter pylori</i> Infection.
   Ho CY, Liu TW, Lin YS, Chen YP, et al · · 2022 · cited 5× · PMID 35208870 · DOI 10.3390/microorganisms10020415