Overview

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

Status:
Unknown status
Trial end date:
2019-10-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shandong University
Treatments:
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Bismuth
Esomeprazole
Furazolidone
Pectin
Rabeprazole
Tetracycline
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.