Personalized Treatment for Refractory H Pylori Infection

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: rabeprazole+bismuth+2 antibiotics; Drug: rabeprazole+3 antibiotics; Drug: rabeprazole+amox+tetr+levo

Study type: Interventional

Funder types: Other

Identifiers

NCT02547025

VGHKS13-CT12-17

Details and patient eligibility

About

In this study, the investigators develop a personalized treatment according to culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori infection.

Full description

They are categorized into three groups: (1) patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics), (2) patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics), and (3) patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

Enrollment: 126 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent.

• positive results of both rapid urease test and histology,
• a positive result of Urea breath test,
• or a positive result of culture

Exclusion criteria

• ingestion of antibiotics, bismuth, or proton-pump inhibitor within the prior 4 weeks,
• patients with allergic history to the medications used,
• patients with previous gastric surgery,
• the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
• pregnant women.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 3 patient groups

rabeprazole+3 antibiotics

Experimental group

Description:

patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days

Treatment:

Drug: rabeprazole+3 antibiotics

rabeprazole+bismuth+2 antibiotics

Experimental group

Description:

patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days

Treatment:

Drug: rabeprazole+bismuth+2 antibiotics

rabeprazole+amox+tetr+levo

Active Comparator group

Description:

patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days

Treatment:

Drug: rabeprazole+amox+tetr+levo