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Trial record 41 of 215 for:    TETRACYCLINE

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

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ClinicalTrials.gov Identifier: NCT03658733
Recruitment Status : Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

Brief Summary:
The purpose of this study is to assess efficacy of a new 14-day sequential therapy for the rescue treatment of refractory Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates. The researchers also want to testify whether a double-dose rabeprazole has equal efficacy to double-dose esomeprazole to provide sufficient acid inhibition.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: esomeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days) 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. This study aims to evaluate the efficacy of 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. Then, this study will also compare the performance of a double-dose esomeprazole with double-dose rabeprazole containing therapy to optimize therapeutic regimen.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel 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: an Open Randomized Pilot Study
Estimated Study Start Date : December 15, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : October 31, 2019


Arm Intervention/treatment
Experimental: Esomeprazole-containing 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 containing esomeprazole for the Helicobacter pylori eradication irrespective of antimicrobial susceptibility test results. The regimen contains esomeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by esomeprazole,amoxicillin, tetracycline and colloidal bismuth pectin for the second 7 days.

Drugs: 1. esomeprazole 40mg bid for 14 days, 2. amoxicillin 1000mg bid for 14 days, 3. tetracycline 500mg qid for 14 days, 4. furazolidone 100mg tid for the first 7 days, 5. colloidal bismuth pectin 200mg bid for the second 7 days.

Drug: esomeprazole, 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 containing esomeprazole for the Helicobacter pylori eradication. The regimen contains a double dose esomeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by esomeprazole, amoxicillin , tetracycline and colloidal bismuth pectin for the second 7 days.

Active Comparator: Rabeprazole-containing 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 containing rabeprazole 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 20mg bid for 14 days, 2. amoxicillin 1000mg bid for 14 days, 3. tetracycline 500mg qid for 14 days, 4. furazolidone 100mg tid for the first 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 containing rabeprazole for the Helicobacter pylori eradication. The regimen contains a double-dose rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole, amoxicillin , tetracycline and colloidal bismuth pectin for the second 7 days.




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 ]
    Parameters of liver and kidney function before and after the treatment will be compared. Common adverse events will be measured and patients will rate the severity of their symptoms from 0 (none) to 8 (severe) points during the treatment process.

  2. The change of dyspepsia symptoms after Helicobacter pylori eradication [ Time Frame: 6 months ]
    Dyspepsia symptoms will be recorded before and after the treatment. Patients will rate the severity of their symptoms from 0 (none) to 8 (severe) points.

  3. The rate of good compliance [ Time Frame: 6 months ]
    Patients taken over 90% of drugs are considered to have a good compliance.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT03658733


Contacts
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Contact: Xiuli Zuo, PhD,MD 8653182169025 ext 8653182169025 qlywc@163.com

Locations
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China, Shandong
Xiuli Zuo Recruiting
Jinan, Shandong, China
Contact: Xiuli Zuo, PhD,MD    15588818685 ext 053188369277    zuoxiuli@sina.com   
Sub-Investigator: Yue Li, MD         
Sub-Investigator: Chaoran Ji, MD         
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Xiuli Zuo, PhD,MD Qilu Hospital of Shandong University

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Responsible Party: Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University
ClinicalTrials.gov Identifier: NCT03658733     History of Changes
Other Study ID Numbers: 2018SDU-QILU-G002
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 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:
Sequential therapy
Rescue treatment
Additional relevant MeSH terms:
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Tetracycline
Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Anti-Bacterial Agents
Furazolidone
Esomeprazole
Rabeprazole
Bismuth
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