Intragastric pH and Bismuth Effect for H. Pylori Eradication
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedStudy Start
First participant enrolled
November 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2019
CompletedJune 3, 2019
October 1, 2016
11 months
July 27, 2016
May 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (7)
(A)Bismuth
ACTIVE COMPARATOR(A)Bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy
(B)Bismuth
ACTIVE COMPARATOR(B)Bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon
(C)Bismuth
ACTIVE COMPARATOR(C)Bismuth (120mg/tab) q.i.d. and endoscopy the next day
(D)Esomeprazole and Bismuth
ACTIVE COMPARATOR(D)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy
(E)Esomeprazole and Bismuth
ACTIVE COMPARATOR(E)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon
(F)Esomeprazole and Bismuth
ACTIVE COMPARATOR(F)3 days esomeprazole (40mg/tab) q.i.d. followed by bismuth (120mg/tab) q.i.d. and endoscopy the next day
(G)Control
OTHER(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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of gastric cancer
- Deferral criteria:
- Having received antibiotic treatment in the previous 15 days
- Need of time to decide participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 10002, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tsung-Hsien Chiang, MD, M.Sc.
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2016
First Posted
September 9, 2016
Study Start
November 15, 2016
Primary Completion
October 18, 2017
Study Completion
February 20, 2019
Last Updated
June 3, 2019
Record last verified: 2016-10