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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03716622
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

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

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Drug: Furazolidone Drug: Clarithromycin Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: bismuth-clarithromycin-containing group
Patients in bismuth-clarithromycin-containing group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and clarithromycin (Klacid) 500mg po bid for 14d
Drug: Clarithromycin
bismuth-clarithromycin-containing quadruple regimens

Experimental: bismuth-furazolidone-containing quadruple group
patients in bismuth-furazolidone-containing quadruple group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 240mg po bid, and furazolidone (Liteling) 100mg po bid for 14d
Drug: Furazolidone
bismuth-furazolidone-containing quadruple regimens

Primary Outcome Measures :
  1. the eradication rate of the two groups [ Time Frame: 26 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03716622

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Contact: Xiuli Zuo, MD,PhD 15588818685 ext 15588818685
Contact: Xiuli Zuo, MD,PhD

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China, Shandong
Qilu hosipital Recruiting
Jinan, Shandong, China, 257000
Contact: Xiuli Zuo, MD,PhD    15588818685 ext 053188369277   
Sub-Investigator: Chen Qiao, MD         
Sub-Investigator: Yueyue Li, MD,PhD         
Sponsors and Collaborators
Shandong University
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Principal Investigator: Xiuli Zuo, MD,PhD Qilu Hospital of Shandong University

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Responsible Party: Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University Identifier: NCT03716622    
Other Study ID Numbers: 2018SDU-QILU-G112
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiuli Zuo, Shandong University:
Helicobacter Pylori
bismuth-containing quadruple regimen
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Gastrointestinal Agents
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Monoamine Oxidase Inhibitors