Skip to content

Intragastric pH and Bismuth Effect for H. Pylori Eradication

Intragastric pH and Bismuth Effect for H. Pylori Eradication

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02894892
Enrollment
21
Registered
2016-09-09
Start date
2016-11-15
Completion date
2019-02-20
Last updated
2019-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Electron Microscopy, Helicobacter pylori, Bismuth

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.

Interventions

DRUG(A)Bismuth
DRUG(B)Bismuth
DRUG(C)Bismuth
DRUG(D)Esomeprazole and Bismuth
DRUG(E)Esomeprazole and Bismuth
DRUG(F)Esomeprazole and Bismuth
OTHER(G)Control

Sponsors

Ministry of Science and Technology, Taiwan
CollaboratorOTHER_GOV
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
No

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 6. Without history of gastric cancer

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

Design outcomes

Primary

MeasureTime frameDescription
The morphological changes of post-drug H. pylori by electron microscopy.3 yearsEndoscopy: 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026