Helicobacter Pylori InfectionNCT02894892
Intragastric pH and Bismuth Effect for H. Pylori Eradication
A study testing (A)Bismuth, (B)Bismuth and (C)Bismuth in people with Helicobacter Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- (A)Bismuth, (B)Bismuth and (C)Bismuth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Nov 2016to 20 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 1.History of gastric cancer
- Deferral criteria:
- Having received antibiotic treatment in the previous 15 days
- Need of time to decide participation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- (A)Bismuth, (B)Bismuth, (C)Bismuth, (D)Esomeprazole and Bismuth, (E)Esomeprazole and Bismuth
- Keywords
- Electron Microscopy, Helicobacter pylori, Bismuth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(A)BismuthDrug
Also called (A)Active Comparator-Bismuth
(B)BismuthDrug
Also called (B)Active Comparator-Bismuth
(C)BismuthDrug
Also called (C)Active Comparator-Bismuth
(D)Esomeprazole and BismuthDrug
Also called (D)Active Comparator-Esomeprazole and Bismuth
(E)Esomeprazole and BismuthDrug
Also called (E)Active Comparator-Esomeprazole and Bismuth
(F)Esomeprazole and BismuthDrug
Also called (F)Active Comparator-Esomeprazole and Bismuth
(G)ControlOther
Also called (G)Other-Control
| Study group | Role | What they receive |
|---|---|---|
| (A)Bismuth | Active comparator | (A)Bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy Receives: Drug: (A)Bismuth |
| (B)Bismuth | Active comparator | (B)Bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon Receives: Drug: (B)Bismuth |
| (C)Bismuth | Active comparator | (C)Bismuth (120mg/tab) q.i.d. and endoscopy the next day Receives: Drug: (C)Bismuth |
| (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 Receives: Drug: (D)Esomeprazole and Bismuth |
| (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 Receives: Drug: (E)Esomeprazole and Bismuth |
| (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 Receives: Drug: (F)Esomeprazole and Bismuth |
| (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. Receives: Other: (G)Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start15 Nov 2016
- Primary completion18 Oct 2017
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Tsung-Hsien Chiang, MD, M.Sc., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894892
- Sponsor's protocol ID
- 201512127MINC
- Status last verified
- Oct 2016
- First submitted
- 27 Jul 2016
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intragastric pH and Bismuth Effect for H. Pylori Eradication
- ClinicalTrials.gov ID
- NCT02894892
- Acronym / sponsor ID
- 201512127MINC
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Electron Microscopy, Helicobacter pylori, Bismuth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| (A)Bismuth | Active comparator | Drug: (A)Bismuth(A)Bismuth (120mg/tab) 1 dose prior 1 hr before endoscopy |
| (B)Bismuth | Active comparator | Drug: (B)Bismuth(B)Bismuth (120mg/tab) 1 dose in the morning and endoscopy in the afternoon |
| (C)Bismuth | Active comparator | Drug: (C)Bismuth(C)Bismuth (120mg/tab) q.i.d. and endoscopy the next day |
| (D)Esomeprazole and Bismuth | Active comparator | 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 |
| (E)Esomeprazole and Bismuth | Active comparator | 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 |
| (F)Esomeprazole and Bismuth | Active comparator | 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 |
| (G)Control | Other | 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. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (A)BismuthAlso: (A)Active Comparator-Bismuth | Drug | (A)Bismuth |
| (B)BismuthAlso: (B)Active Comparator-Bismuth | Drug | (B)Bismuth |
| (C)BismuthAlso: (C)Active Comparator-Bismuth | Drug | (C)Bismuth |
| (D)Esomeprazole and BismuthAlso: (D)Active Comparator-Esomeprazole and Bismuth | Drug | (D)Esomeprazole and Bismuth |
| (E)Esomeprazole and BismuthAlso: (E)Active Comparator-Esomeprazole and Bismuth | Drug | (E)Esomeprazole and Bismuth |
| (F)Esomeprazole and BismuthAlso: (F)Active Comparator-Esomeprazole and Bismuth | Drug | (F)Esomeprazole and Bismuth |
| (G)ControlAlso: (G)Other-Control | Other | (G)Control |
Primary outcome
The morphological changes of post-drug H. pylori by electron microscopy.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsung-Hsien Chiang, MD, M.Sc. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (A)Bismuth, (B)Bismuth and (C)Bismuth in people with Helicobacter Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The morphological changes of post-drug H. pylori by electron microscopy. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.