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

Phase 2

Withdrawn

• Conditions: H. Pylori Infection
• Interventions: Drug: Acetazolamide group; Drug: Standard regimen group

• Registration Number: NCT02090738
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Last Update Submitted: 2014-04-27
• Last Update Posted: 2014-04-29
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm1	Acetazolamide group	Treatment group
Arm2	Standard regimen group	Control group

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate	1 month from the eradication therapy	H. pylori eradication rate will be assessed by urea breath test after eradication therapy.

Trial Locations

Locations (1)

severnace Hospital; 🇰🇷 Seoul, Seodaemun-gu, Korea, Republic of