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Efficacy and safety of PPI based triple therapy with low dose clarithromycin for clarithromycin sensitive Helicobacter pylori eradication

Efficacy and safety of proton pump inhibitor-based triple therapy with half dose clarithromycin for clarithromycin sensitive Helicobacter pylori eradication

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0009996
Enrollment
234
Registered
2024-12-05
Start date
2024-09-24
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

None listed

Interventions

Drug : The dosage of clarithromycin for the treatment regimen for H. pylori eradication therapy will be adjusted as follows
1) study group
Dexilant 60mg , ampicillin 500mg, clarithromycin SR 250 mg 2) control group: Dexilant 60mg , ampicillin 500mg, clarithromycin SR 500 mg

Sponsors

Chonnam National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients eligible for eradication therapy were selected based on the following criteria after undergoing gastroscopy and H. pylori PCR testing, confirming the absence of clarithromycin resistance gene mutations (A2143G, A2142G): 1) Aged between 18 and 75 years 2) Positive for H. pylori PCR 3) No A2143G or A2142G mutations 4) History of conditions such as atrophic gastritis, peptic ulcer, low-grade MALT lymphoma, functional dyspepsia, idiopathic thrombocytopenic purpura, iron 5) deficiency anemia, hyperplastic polyps, history of endoscopic resection for gastric cancer or adenoma, or family history of gastric cancer 6) Patients who voluntarily signed the consent form.

Exclusion criteria

Exclusion criteria: 1) Previous experience with eradication therapy 2) History of surgeries that may affect gastric acid secretion or plans for such surgeries 3) Conditions associated with increased gastric acid secretion (e.g., Zollinger-Ellison syndrome) 4) Gastric outlet obstruction 5) Pregnant or breastfeeding women 6) History of allergies to the study medication 7) Patients unwilling to undergo eradication therapy 8) Patients taking contraindicated medications (e.g., atazanavir, nelpivirine, or rilpivirine) or those with hypersensitivity or intolerance to these medications 9) Renal impairment (e-GFR three times the upper limit of normal) 10) Patients with gastrointestinal bleeding 11) Patients showing abnormal ECG results, such as QT prolongation 12) Patients with central nervous system infections, infectious mononucleosis, or electrolyte imbalances (e.g., hypokalemia, hypomagnesemia) 13) Patients who do not agree to use appropriate contraception during the study period, either personally or with their partner.

Design outcomes

Primary

MeasureTime frame
The eradication rate of H. pylori

Secondary

MeasureTime frame
Medication adherence and medication side effects

Countries

Korea, Republic of

Contacts

Public ContactSeon-Young Park

Chonnam National University Hospital

drpsy@naver.com+82-62-220-6205

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026