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Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy

Comparing the Efficacy and Impact on Gastrointestinal Microbiome of Reverse Hybrid Therapy and Bismuth Quadruple Therapy in Helicobacter Pylori Eradication

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02547038
Enrollment
352
Registered
2015-09-11
Start date
2015-02-28
Completion date
2018-10-31
Last updated
2019-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori, Eradication rate

Brief summary

Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Detailed description

A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Interventions

DRUGpantoprazole+bismuth+tetra+metro

pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

DRUG(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 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Sponsors

Kaohsiung Veterans General Hospital.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants in Which H. Pylori Was Eradicatedsixth week after the end of anti- H. pylori therapyEvaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori)

Countries

Taiwan

Participant flow

Recruitment details

recruitment period: August 2015 through February 2017. Type of location: Kaohsiung Veterans General Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital

Pre-assignment details

None were excluded following participant enrollment.

Participants by arm

ArmCount
Pantoprazole+Bismuth+Tetra+Metro
pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
176
(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 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily (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 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
176
Total352

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up32

Baseline characteristics

CharacteristicPantoprazole+Bismuth+Tetra+Metro(Panto+Amox+Clar+Metr)+(Panto+Amox)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
31 Participants39 Participants70 Participants
Age, Categorical
Between 18 and 65 years
145 Participants137 Participants282 Participants
Age, Continuous53.8 years
STANDARD_DEVIATION 12.1
54.5 years
STANDARD_DEVIATION 12.9
54.2 years
STANDARD_DEVIATION 12.5
History of smoking24 participants35 participants59 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
176 Participants176 Participants352 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Taiwan
176 participants176 participants352 participants
Sex: Female, Male
Female
97 Participants87 Participants184 Participants
Sex: Female, Male
Male
79 Participants89 Participants168 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1760 / 176
other
Total, other adverse events
86 / 17633 / 176
serious
Total, serious adverse events
0 / 1760 / 176

Outcome results

Primary

Number of Participants in Which H. Pylori Was Eradicated

Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori)

Time frame: sixth week after the end of anti- H. pylori therapy

Population: Intention to treat

ArmMeasureValue (NUMBER)
Pantoprazole+Bismuth+Tetra+MetroNumber of Participants in Which H. Pylori Was Eradicated169 participants
(Panto+Amox+Clar+Metr)+(Panto+Amox)Number of Participants in Which H. Pylori Was Eradicated170 participants

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026