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

NCT03616405 | Unknown Phase 4 DMC

• 1 other identifier: 2018SDU-QILU-G001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Sequential Therapy; Rescue Treatment

Outcome Measures

Primary Outcomes (1)

• Eradication rates

  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.

  6 months

Secondary Outcomes (3)

• The rate of adverse events happening

  6 months

• The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.

  6 months

• The rate of good compliance

  6 months

Study Arms (1)

14-day modified sequential therapy

EXPERIMENTAL

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)

Interventions

rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days) DRUG

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.

14-day modified sequential therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Xiuli Zuo

Jinan, Shandong, China

Location

MeSH Terms

Interventions

Rabeprazole; Amoxicillin; Tetracycline; Furazolidone; Single Person

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitrofurans; Nitro Compounds; Oxazolidinones; Oxazoles; Azoles; Furans; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Xiuli Zuo, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

15588818685; zuoxiuli@sina.com

Xiuli Zuo, MD,PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: April 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: April 30, 2020
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

CN (1)