Pilot Study of a 14-day Modified Sequential Therapy for Helicobacter Pylori Infection

• ClinicalTrials.gov Identifier: NCT03616405
• Recruitment Status: Not yet recruiting
• First Posted: August 6, 2018
• Last Update Posted: March 8, 2019
• Sponsor: Shandong University
• Information provided by (Responsible Party): Xiuli Zuo, Shandong University

Study Description

Brief Summary:

The purpose of this study is to assess efficacy of a 14-day sequential therapy for the rescue treatment of refractory Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.

Condition or disease	Intervention/treatment	Phase
Helicobacter Pylori Infection	Drug: rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)	Phase 4

Detailed Description:

Half of the world's population is infected with Helicobacter pylori. Strong evidence supports that H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly emerging antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.

Traditional sequential therapy failed to achieve an ideal eradication rates (over>95%) as a third line treatment in the region with high antibiotic resistance. The investigator's study aims to evaluate the efficacy 14-day modified sequential therapy in the patients with two or more treatment failure, and whether the adverse effects of this new modified sequential therapy are tolerable.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of a 14-day Modified Sequential Therapy for Refractory Helicobacter Pylori Infection: a Pilot Study
• Estimated Study Start Date: April 1, 2019
• Estimated Primary Completion Date: November 30, 2019
• Estimated Study Completion Date: April 30, 2020

Arms and Interventions

Arm

Intervention/treatment

Experimental: 14-day modified sequential therapy; All the participants will go through a gastroscopy. Biopsy specimens will be taken for histologic assessment and rapid urease test. Two additional biopsy samples will be obtained from the antrum and body for bacterial culture and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy for the Helicobacter pylori eradication irrespective of antimicrobial susceptibility test results. The regimen contains rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole，amoxicillin, tetracycline and colloidal bismuth pectin for the second 7 days. Drugs: 1. rabeprazole 10mg bid for 14 days, 2. amoxicillin 1000mg bid for 14 days, 3. tetracycline 500mg qid for 14 days, 4. furazolidone 100mg tid for the firs 7 days, 5. colloidal bismuth pectin 200mg bid for the second 7 days.

Drug: rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days); Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy for the Helicobacter pylori eradication. The regimen contains rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole，amoxicillin, tetracycline and colloidal bismuth pectin for the second 7 days.

Outcome Measures

Primary Outcome Measures :

1. Eradication rates [ Time Frame: 6 months ]
   Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

Secondary Outcome Measures :

1. The rate of adverse events happening [ Time Frame: 6 months ]
   Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.
2. The rate of improving dyspepsia symptoms after Helicobacter pylori eradication. [ Time Frame: 6 months ]
   Dyspepsia symptoms will also be measured using a 8-point Likert scale
3. The rate of good compliance [ Time Frame: 6 months ]
   Patients taken over 90% of drugs are considered to have a good compliance.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients aged 18-70 with persistent H. pylori infection.
• Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

Exclusion Criteria:

• Patients unable or unwilling to receive gastroscopy.
• Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
• Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
• History of allergy to any of the drugs used in the study.
• Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
• Currently pregnant or lactating.
• Severe neurologic or psychiatric disorders.
• Alcohol abuse or drug addiction.
• Patients with compliance lower than 90% in any previous treatment are not included.
• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Contacts and Locations

Contacts

Contact: Xiuli Zuo, MD,PhD; 15588818685; zuoxiuli@sina.com

Contact: Xiuli Zuo, MD,PhD

Locations

China, Shandong

Xiuli Zuo

Jinan, Shandong, China

Sponsors and Collaborators

Shandong University

Investigators

• Principal Investigator: Xiuli Zuo, MD,PhD; Qilu Hospital of Shandong University

More Information

• Responsible Party: Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University
• ClinicalTrials.gov Identifier: NCT03616405 History of Changes
• Other Study ID Numbers: 2018SDU-QILU-G001
• First Posted: August 6, 2018
• Last Update Posted: March 8, 2019
• Last Verified: March 2019

• 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:

Sequential Therapy; Rescue Treatment

Additional relevant MeSH terms:

Tetracycline; Infection; Communicable Diseases; Helicobacter Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Amoxicillin; Furazolidone; Rabeprazole; Bismuth; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antacids; Protein Synthesis Inhibitors; Anti-Infective Agents, Local; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Antiprotozoal Agents; Antiparasitic Agents; Monoamine Oxidase Inhibitors