Intragastric pH and Bismuth Effect for H. Pylori Eradication

Study Overview
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Brief Summary
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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.

Official Title
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Intragastric pH and Bismuth Effect for H. Pylori Eradication

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: (A)Bismuth
* Drug: (B)Bismuth
* Drug: (C)Bismuth
* Drug: (D)Esomeprazole and Bismuth
* Drug: (E)Esomeprazole and Bismuth
* Drug: (F)Esomeprazole and Bismuth
* Other: (G)Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (A)Bismuth<br>(A)Bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy | Drug: (A)Bismuth<br> <br> * Other names: (A)Active Comparator-Bismuth;|
| Active Comparator: (B)Bismuth<br>(B)Bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon | Drug: (B)Bismuth<br> <br> * Other names: (B)Active Comparator-Bismuth;|
| Active Comparator: (C)Bismuth<br>(C)Bismuth (120mg/tab) q.i.d. and endoscopy the next day | Drug: (C)Bismuth<br> <br> * Other names: (C)Active Comparator-Bismuth;|
| Active Comparator: (D)Esomeprazole and Bismuth<br>(D)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy | Drug: (D)Esomeprazole and Bismuth<br> <br> * Other names: (D)Active Comparator-Esomeprazole and Bismuth;|
| Active Comparator: (E)Esomeprazole and Bismuth<br>(E)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon | Drug: (E)Esomeprazole and Bismuth<br> <br> * Other names: (E)Active Comparator-Esomeprazole and Bismuth;|
| Active Comparator: (F)Esomeprazole and Bismuth<br>(F)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) q.i.d. and endoscopy the next day | Drug: (F)Esomeprazole and Bismuth<br> <br> * Other names: (F)Active Comparator-Esomeprazole and Bismuth;|
| Other: (G)Control<br>(G)These patients underwent endoscopy due to abdominal discomfort or other symptoms and did not have cancers in the digestive tract after series of workup. | Other: (G)Control<br> <br> * Other names: (G)Other-Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The morphological changes of post-drug H. pylori by electron microscopy. | 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. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electron Microscopy, Helicobacter pylori, Bismuth