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Efficacy comparison of 7 and 14-days P-CAB based bismuth-containing quadruple regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori infection: open-label, randomized controlled trial

Efficacy comparison of 7 and 14-days P-CAB based bismuth-containing quadruple regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori infection: open-label, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007444
Enrollment
366
Registered
2022-06-28
Start date
2022-07-11
Completion date
Unknown
Last updated
2022-09-20

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

Conditions

None listed

Interventions

Drug : Eligible patients will be randomized in three groups. In the first group, patients will be assigned to a 7-day PC-BMT therapy (Tegoprazan 50mg bid, bismuth subcitrate 300mg qid, metronidazole 2

Sponsors

Hallym University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) age >19 or <85 years 2) patients who tested positive for H. pylori 3) patients who had endoscopically confirmed gastric ulcer, duodenal ulcer (including scar), low grade gastric MALT lymphoma, gastric dysplasia or early gastric cancer, Atrophic gastritis, H. pylori gastritis 4) patients who will be compliant to study procedures 5) patients who have signed the Informed Consent 6) patients who have agreed to use acceptable contraception methods

Exclusion criteria

Exclusion criteria: 1) previous H. pylori eradication therapy 2) patients with severe concurrent disease or malignancy 3) history of gastrectomy 4) patients who used PPI, H2 blocker, Histamine H2-receptor antagonists 14 days prior to trial 5) patients who have taken bismuth-containing drugs or antibiotics within 28 days prior to trial 6) pregnant or lactating women 7) liver cirrhosis or Hepatic insufficiency 8) renal insufficiency 9) other organ cancer within 5 years 10) history of stomach operation 11) addiction to alcohol or illicit and recreational drugs 12) a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine 13) patients receiving statin therapy

Design outcomes

Primary

MeasureTime frame
H. pylori eradication rate

Secondary

MeasureTime frame
drug compliance

Countries

Korea, Republic of

Contacts

Public ContactHyun Lim

Hallym University

hlim77@hallym.or.kr+82-31-380-3710

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 9, 2026