Intragastric pH and Bismuth Effect for H. Pylori Eradication

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: (E)Esomeprazole and Bismuth; Drug: (B)Bismuth; Drug: (D)Esomeprazole and Bismuth; Drug: (A)Bismuth; Drug: (C)Bismuth; Drug: (F)Esomeprazole and Bismuth; Other: (G)Control

• Registration Number: NCT02894892
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-09-04
• Study First Posted: 2016-09-09
• Status Verified: 2016-10
• Study Start: 2016-11-15
• Primary Completion: 2017-10-18
• Study Completion: 2019-02-20
• Last Update Submitted: 2019-05-30
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
(E)Esomeprazole and Bismuth	(E)Esomeprazole and Bismuth	(E)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon
(B)Bismuth	(B)Bismuth	(B)Bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon
(D)Esomeprazole and Bismuth	(D)Esomeprazole and Bismuth	(D)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy
(A)Bismuth	(A)Bismuth	(A)Bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy
(C)Bismuth	(C)Bismuth	(C)Bismuth (120mg/tab) q.i.d. and endoscopy the next day
(F)Esomeprazole and Bismuth	(F)Esomeprazole and Bismuth	(F)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) q.i.d. and endoscopy the next day
(G)Control	(G)Control	(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.

Primary Outcome Measures

Name	Time	Method
The morphological changes of post-drug H. pylori by electron microscopy.	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan