H. Pylori Infection
Conditions
Brief summary
The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.
Detailed description
Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies. H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.
Interventions
DRUGesomeprazole plus amoxicillin
amoxicillin 750mg QID + esomeprazole 20mg QID for 14 days
DRUGamoxicillin, furazolidone, bismuth potassium citrate , esomeprazole
amoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patients who were diagnosed with persistent H. pylori infection and had previously failed one or more courses of eradication therapies that included amoxicillin, clarithromycin, or nitroimidazole.
Exclusion criteria
* Age \< 18 years old. * The time frame was less than 6 months from the previous eradication therapy. * The previous eradication therapy included furazolidone. * Allergic to the medication. * Pregnant or lactating women. * Comorbidities of severe conditions like hepatic, renal or cardiorespiratory diseases or malignancy. * Administration of antibiotics, bismuth or PPI in the preceding 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eradication rate | 42 days | eradication rate of H pylori, presenting with negative results on the 13C-UBT test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| frequency of the adverse events | 42 days | incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever. |
| compliance rate of the drugs | 42 days | Compliance was defined as good when they had taken more than 80% of the total medication. |
Countries
China
Contacts
Primary ContactJie Chen, MD
Backup ContactChengzhao Weng, MD
Outcome results
None listed