A Randomized, Open-label Study on Helicobacter Pylori Eradication With Standard Triple Regimen Plus Acetazolamide

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02090738

Enrollment

Registered

2014-03-18

Start date

2014-03-31

Completion date

Unknown

Last updated

2014-04-29

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

Conditions

H. Pylori Infection

Brief summary

Helicobacter pylori infection is associated with several gastric diseases, including gastritis, peptic and duodenal ulcers, gastric carcinoma and MALToma. In 1994, the WHO classified the organism as a type 1 carcinogen. In order to eradicate H. pylori, at least two antibiotics and a proton pump inhibitor are used as a standard therapy regimen. Emerging antibiotic resistance to metronidazole or clarithromycin, however, has made successful treatment of infection progressively more difficult, with the success rate of standard triple therapy now at 70%, well below the 80% required for treatment of infectious diseases. Therefore, new treatment regimen is required for successful H. pylori eradication. On the other hands, many in vitro studies revealed that bacterial carbonic anhydrase in H. pylori has an important role for surviving of H. pylori in the stomach. It was demonstrated that mutation of carbonic anhydrase affected survival of H. pylori. The investigators therefore expected that administration of carbonic anhydrase inhibitor (acetazolamide) with standard H. pylori eradication regimen would increase the eradication rate. Here, the investigators aim to evaluate the efficacy of standard triple regimen plus acetazolamide for H. pylori eradication.

Interventions

DRUGAcetazolamide group

DRUGStandard regimen group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Age, between 19 and 70 2. H. pylori infected patients

Exclusion criteria

1. Previous history of H. pylori eradication 2. Previous history of gastrectomy 3. Administration of PPI, H2 blocker, antibiotics, or bismuth within 1 month prior to enrollment 4. Allergy to sulfonamide 5. Electrolyte imbalance 6. Adrenal insufficiency 7. Pregnancy or breast milk feeding 8. Active infection 9. Severe hepatic dysfunction 10. Severe renal dysfunction 11. Severe bone marrow dysfunction 12. Significant neurologic or psychologic disease

Design outcomes

Primary

Measure	Time frame	Description
H. pylori eradication rate	1 month from the eradication therapy	H. pylori eradication rate will be assessed by urea breath test after eradication therapy.

Countries

South Korea

Outcome results

None listed

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