Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication

Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication: a Multicentre, Randomised, Controlled Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06723197

Enrollment

330

Registered

2024-12-09

Start date

2024-12-10

Completion date

2025-11-30

Last updated

2024-12-11

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

Conditions

HELICOBACTER PYLORI INFECTIONS

Brief summary

The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

Interventions

DRUGvonoprazan+amoxicillin

Drug combinations for dual regimens：vonoprazan+amoxicillin

OTHERDuration of eradication regimen: 7-day

Duration of eradication regimen: 7-day

DRUGvonoprazan+amoxicillin+tetracycline+bismuth

Drug combinations for quadruple regimens: vonoprazan+amoxicillin+tetracycline+bismuth

OTHERDuration of eradication regimen: 10-day

Duration of eradication regimen: 10-day

OTHERDuration of eradication regimen: 14-day

Duration of eradication regimen: 14-day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Patients aged 18-70 years old 2. Patients with H.pylori infection (13C/14C-urea breath test) 3. Patients without previous treatment for H. pylori eradication

Exclusion criteria

1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75% 2. Patients with active gastrointestinal bleeding 3. Patients with a history of upper gastrointestinal surgery 4. Patients allergic to treatment drugs 5. Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks 6. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial 7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse 8. Patients who are unwilling or incapable to provide informed consents

Design outcomes

Primary

Measure	Time frame	Description
Eradication rate	Six weeks after treatment	13C-urea breath test was used to determine whether eradication was successful. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in the three groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

Secondary

Measure	Time frame	Description
Rate of adverse reactions	Immediately after treatment	Drug-related adverse reactions needs to be recorded after treatment
Patient compliance	Immediately after treatment	The number of missed and overdosed doses of medication needs to be completed after treatment.

Countries

China

Contacts

Primary ContactYanqing Li, Ph.D

liyanqing@sdu.edu.cn+8653188369277

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026