Comparing the Efficacy of 14-day Reverse Hybrid Therapy and 14-day Triple Therapy Plus Bismuth Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-12-31

Brief Summary

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Reverse hybrid therapy achieves a higher eradication rate than bismuth (triple therapy plus bismuth) remains unanswered

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Detailed Description

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With the rising prevalence of antimicrobial resistance, the failure rate of the 7-day standard triple therapy has declined to unacceptable level (\<80%) worldwide. Several regimens were suggested to replace standard triple therapy in the area with high clarithromycin resistance, including sequential therapy, concomitant therapy, hybrid therapy and bismuth containing quadruple therapy. A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving eradication rates of 95%. A clinical trial by Hsu et al from our hospital showed 12-day reverse hybrid therapy also achieved high eradication rate, and improved the compliance of patients. Even prolong the treatment duration of standard triple therapy from 7 days to 12 days, the efficacy of eradication was still \< 90% (85-88%). The limitation of triple therapy in against resistant-stains was still existed. The addition of bismuth (triple therapy plus bismuth) can improve cure rates despite a high prevalence of antimicrobial resistance. The major bismuth effect is to add an additional 30%-40% to the success with resistant infections. However the direct compare the efficacy between 14-day reverse hybrid therapy and 14-day triple therapy plus bismuth is still insufficiency in Taiwan and worldwide. Choosing a navel therapy or a modifying triple therapy can get better efficacy, it is remained to be determined. Besides genotyping polymorphism of CYP2C19 influenced the metabolism of proton pump inhibit, and could cause decreasing of eradication rate of standard triple therapy. But the influence in 14-day reverse hybrid therapy and 14-day triple therapy plus bismuth is unclear.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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triple therapy plus bismuth therapy

pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.

Group Type EXPERIMENTAL

triple therapy plus bismuth therapy

Intervention Type DRUG

pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.

reverse hybrid therapy

(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days)

Group Type ACTIVE_COMPARATOR

reverse hybrid therapy

Intervention Type DRUG

(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days)

Interventions

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triple therapy plus bismuth therapy

pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.

Intervention Type DRUG

reverse hybrid therapy

(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days)

Intervention Type DRUG

Other Intervention Names

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pantoprazole 40 mg amoxicillin 1g clarithromycin 500mg bismuth subcitrate 240mg pantoprazole 40mg amoxicillin 1g clarithromycin 500mg metronidazole 500mg

Eligibility Criteria

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Inclusion Criteria

* Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria

* previous H pylori-eradication therapy
* ingestion of antibiotics or bismuth 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No