Comparing the Efficacy of 10-day Reverse Hybrid Therapy and 10-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

2020-01-01

Study Completion Date

2022-12-31

Brief Summary

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Reverse hybrid therapy achieves a higher eradication rate than triple therapy plus bismuth therapy 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 10-day reverse hybrid therapy and 10-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 10-day reverse hybrid therapy and 10-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

SINGLE

Investigators

Study Groups

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(panto+amox+clar+metr)+(panto+amox)

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Group Type EXPERIMENTAL

(panto+amox+clar+metr)+(panto+amox)

Intervention Type DRUG

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

pantoprazole+bismuth+amox+clar

pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days

Group Type ACTIVE_COMPARATOR

pantoprazole+bismuth+amox+clar

Intervention Type DRUG

pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days

Interventions

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(panto+amox+clar+metr)+(panto+amox)

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Intervention Type DRUG

pantoprazole+bismuth+amox+clar

pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days

Intervention Type DRUG

Other Intervention Names

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pantoprazole 40 mg amoxicillin 1 g clarithromycin 500 mg metronidazole 500 mg pantoprazole 40 mg bismuth subcitrate 120 mg amoxicillin 1 g clarithromycin 500 mg

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