Intragastric pH and Bismuth Effect for H. Pylori Eradication

NCT ID: NCT02894892

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-15
• Study Completion Date: 2019-02-20

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.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

(A)Bismuth

(A)Bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy

Group Type: ACTIVE_COMPARATOR

(A)Bismuth

Intervention Type: DRUG

(B)Bismuth

(B)Bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon

Group Type: ACTIVE_COMPARATOR

(B)Bismuth

Intervention Type: DRUG

(C)Bismuth

(C)Bismuth (120mg/tab) q.i.d. and endoscopy the next day

Group Type: ACTIVE_COMPARATOR

(C)Bismuth

Intervention Type: DRUG

(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

Group Type: ACTIVE_COMPARATOR

(D)Esomeprazole and Bismuth

Intervention Type: DRUG

(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

Group Type: ACTIVE_COMPARATOR

(E)Esomeprazole and Bismuth

Intervention Type: DRUG

(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

Group Type: ACTIVE_COMPARATOR

(F)Esomeprazole and Bismuth

Intervention Type: DRUG

(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.

Group Type: OTHER

(G)Control

Intervention Type: OTHER

Interventions

(A)Bismuth

Intervention Type: DRUG

(B)Bismuth

Intervention Type: DRUG

(C)Bismuth

Intervention Type: DRUG

(D)Esomeprazole and Bismuth

Intervention Type: DRUG

(E)Esomeprazole and Bismuth

Intervention Type: DRUG

(F)Esomeprazole and Bismuth

Intervention Type: DRUG

(G)Control

Intervention Type: OTHER

Other Intervention Names

(A)Active Comparator-Bismuth; (B)Active Comparator-Bismuth; (C)Active Comparator-Bismuth; (D)Active Comparator-Esomeprazole and Bismuth; (E)Active Comparator-Esomeprazole and Bismuth; (F)Active Comparator-Esomeprazole and Bismuth; (G)Other-Control

Eligibility Criteria

Inclusion Criteria

1. Age 20-69

2. Confirmed H. pylori infection by urea breath test or previous histology

3. Scheduled endoscopy

4. Mentally competent to be able to understand the consent form for individuals equal to or older than 20

5. Able to communicate with study staff for individuals equal to or older than 20

Exclusion Criteria

1.History of gastric cancer

Deferral criteria:

1. Having received antibiotic treatment in the previous 15 days

2. Need of time to decide participation

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsung-Hsien Chiang, MD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201512127MINC

Identifier Type: -

Identifier Source: org_study_id