- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02894892
Intragastric pH and Bismuth Effect for H. Pylori Eradication
May 30, 2019 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: (A)Bismuth
(A)Bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy
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Other Names:
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Active Comparator: (B)Bismuth
(B)Bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon
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Other Names:
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Active Comparator: (C)Bismuth
(C)Bismuth (120mg/tab) q.i.d. and endoscopy the next day
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Other Names:
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Active Comparator: (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
|
Other Names:
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Active Comparator: (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
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Other Names:
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Active Comparator: (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
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Other Names:
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Other: (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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The morphological changes of post-drug H. pylori by electron microscopy.
Time Frame: 3 years
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tsung-Hsien Chiang, MD, M.Sc., National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2016
Primary Completion (Actual)
October 18, 2017
Study Completion (Actual)
February 20, 2019
Study Registration Dates
First Submitted
July 27, 2016
First Submitted That Met QC Criteria
September 4, 2016
First Posted (Estimate)
September 9, 2016
Study Record Updates
Last Update Posted (Actual)
June 3, 2019
Last Update Submitted That Met QC Criteria
May 30, 2019
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201512127MINC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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