A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication

Helicobacter Pylori Clinical Trial

Official title:

A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716622
• Other study ID #: 2018SDU-QILU-G112
• Status: Completed
• Phase: Phase 4
• Start date: July 31, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: June 2020
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We aim to assess and compare the effectiveness of clarithromycin- and furazolidone-based regimens as primary therapies in eradicating H. pylori.

Description:

Helicobacter pylori plays a pivotal role in many diseases such as peptic ulcer disease and MALT lymphomas. And the prevalence of H. pylori is increasing in some parts of the world.

However, the eradication becomes increasingly difficult due to the growing antibiotic resistance. Bismuth-containing quadruple regimens are now recommended to serve as first-line therapies. Bismuth-clarithromycin-containing and bismuth-furazolidone-containing quadruple regimens are both in the list of the first regimens. And recent antimicrobial susceptibility tests showed us that the clarithromycin was increasingly resisted while furazolidone remained hardly resisted. The comparison between the effects of bismuth-clarithromycin-containing and bismuth-furazolidone-containing quadruple regimens is not so clear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients, aged between 18 and 75years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

• Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Related Conditions & MeSH terms

• Helicobacter Pylori

Intervention

Drug:
• Furazolidone
bismuth-furazolidone-containing quadruple regimens
• Clarithromycin
bismuth-clarithromycin-containing quadruple regimens

Locations

Country	Name	City	State
China	Qilu hosipital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the eradication rate of the two groups		26 months