Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, rescue therapy
Brief summary
Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.
Interventions
DRUGVonoprazan
Proton pump inhibitor
DRUGBismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
DRUGTetracycline
Antibiotics for H. pylori eradication
DRUGMetronidazole
Antibiotics for H. pylori eradication
DRUGAmoxicillin
Antibiotics for H. pylori eradication
DRUGRifabutin
Antibiotics for H. pylori eradication
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Ability and willingness to participate in the study and to sign and give informed consent * Confirmed H. pylori infection and with previous treatment experience
Exclusion criteria
* subjects naive to H. pylori treatment, * under 18 or over 80 years old * history of gastrectomy * pregnant or lactating women * Previous history of tuberculosis * Allergy to any of the study drugs * severe systemic diseases or malignancy * administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradication rate | Six weeks after completion of therapy | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse effects | Within 7 days after completion of therapy | The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as mild (transient and well tolerated), moderate (causing discomfort and partially interfering with daily activities), or severe (causing considerable interference with daily activities). In addition, blood test were messured to access function of liver and kidney. |
| Compliance rate | Within 7 days after completion of therapy | Compliance was defined as poor when they had taken less than 80% of the total medication |
Countries
China
Outcome results
None listed