Skip to main content
OpenTrials
Completed

NCT Number: NCT02894892

Intragastric pH and Bismuth Effect for H. Pylori Eradication

Gastric cancer is one of the leading causes of cancer-related deaths worldwide. In Taiwan, there are around 3800 fresh cases annually, with about 5% of total cancers cases. Gastric cancer development is known to follow a multistate process from non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, dysplasia, and carcinoma; H. pylori infection plays the key role of this carcinogenic process. Although H. pylori eradication would result in a marked gastric cancer reduction, treatment success using standard regimens has become more difficult in recent years, and increased antibiotic resistance is considered the most important reason for decreased treatment efficacy. As no specific new medications have been introduced in recent years, novel treatment regimens have been created using different combinations, durations and sequences of available medications. The addition of bismuth improved the cure rates despite a high prevalence of resistance, and resistance of H. pylori to bismuth has not been reported. Bismuth absorption is not required for efficacy in H. pylori treatment regimens, suggesting a local mechanism of action. The mechanisms of bismuth with responsible for rapid destruction of H. pylori within the stomach remain unclear. Knowledge of the mechanism of action of bismuth compounds against H. pylori would be beneficial in the development of improved treatment regimens in this era of declining eradication success rates. We conduct the pilot study to evaluate the bacteria fragments of H. pylori in specimen through electron microscopy after bismuth therapy and provide insight into the mechanism of action of pH on bismuth therapy. We also help to develop optimal H. pylori therapeutic strategies.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20-69
  • Confirmed H. pylori infection by urea breath test or previous histology
  • Scheduled endoscopy
  • Mentally competent to be able to understand the consent form for individuals equal to or older than 20
  • Able to communicate with study staff for individuals equal to or older than 20
  • Without history of gastric cancer Exclusion criteria

1.History of gastric cancer

Deferral criteria:

  • Having received antibiotic treatment in the previous 15 days
  • Need of time to decide participation

Treatment and study plan

(A)Bismuth

Drug

Other names: (A)Active Comparator-Bismuth

(B)Bismuth

Drug

Other names: (B)Active Comparator-Bismuth

(C)Bismuth

Drug

Other names: (C)Active Comparator-Bismuth

(D)Esomeprazole and Bismuth

Drug

Other names: (D)Active Comparator-Esomeprazole and Bismuth

(E)Esomeprazole and Bismuth

Drug

Other names: (E)Active Comparator-Esomeprazole and Bismuth

(F)Esomeprazole and Bismuth

Drug

Other names: (F)Active Comparator-Esomeprazole and Bismuth

(G)Control

Other

Other names: (G)Other-Control

Primary outcomes

  1. The morphological changes of post-drug H. pylori by electron microscopy.

    Time frame: 3 years

    Endoscopy: The biopsy procedure protocol specified sampling gastric mucosa in the locations of gastric antrum, body and cardia (two specimens from each location). Specimens would be sent for electron microscopy.

    Electron microscopy: Bacteria fragments of H. pylori would be observed.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Sep 9, 2016
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.