Helicobacter pylori was discovered in 1982, and since then, it has been known to increase the risk of gastrointestinal diseases such as chronic gastritis, peptic ulcers, and gastric cancer. Therefore, eradication therapy is performed in cases of peptic ulcers, gastric cancer, and atrophic gastritis.
According to the Korean guideline for Helicobacter pylori treatment, therapies including proton pump inhibitors are recommended for eradication. Recently, a potassium-competitive acid blocker (PCAB), which has a stronger inhibitory effect on gastric acid secretion than proton pump inhibitors, has been developed, raising expectations that this new drug may aid in the eradication of Helicobacter pylori. The Japanese guideline for Helicobacter pylori treatment recommend vonoprazan, a potassium-competitive acid blocker, as an eradication agent.
Fexuprazan, a potassium-competitive acid blocker approved by the KFDA, has been verified for its strong and longer-lasting acid inhibitory effects and could be used for the eradication of Helicobacter pylori.
In first-line treatment for Helicobacter pylori, the Korean guideline suggests triple therapy, sequential therapy, or concomitant therapy. However, American and European guidelines do not recommend triple therapy in regions where the clarithromycin resistance rate exceeds 15%, instead recommending concomitant therapy. Recent papers report the clarithromycin resistance rate in Korea to be between 17.8% and 31.0%. Considering the increasing trend of clarithromycin resistance in Korea, concomitant therapy may be more advantageous for eradication than triple therapy.
Therefore, this study aims to verify the efficacy and safety of a 10-day concomitant therapy based on fexuprazan as a first-line treatment for Helicobacter pylori.

Treatment

A regimen of fexuprazan 40 mg, clarithromycin 500 mg, amoxicillin 1 g, and metronidazole 500 mg twice daily for 10 days will be administered to patients diagnosed with Helicobacter pylori infection. Following this treatment, the eradication status and any adverse reactions will be assessed.

Arm Label

Target Number of Participant

Arm Type

Arm Description

A regimen of fexuprazan 40 mg, clarithromycin 500 mg, amoxicillin 1 g, and metronidazole 500 mg twice daily for 10 days will be administered.

Gender

Age

Description

1. Aged between 19 and under 75 years old.
2. Diagnosed with Helicobacter pylori infection. Diagnosis is confirmed if any of the following criteria are met: positive rapid urease test during esophagograstroduodenoscopy, positive Helicobacter pylori PCR on tissue samples, detection of Helicobacter pylori in tissue biopsy (histochemical staining), or positive urea breath test.
3. Meeting one of the following indications: peptic ulcer (including scar), early gastric cancer, gastric adenoma, atrophic gastritis, iron deficiency anemia, MALT lymphoma, idiopathic thrombocytopenic purpura, functional dyspepsia, or a family history of gastric cancer.
4. Individuals who have voluntarily provided written consent.
5. Female patients of childbearing age willing to maintain contraception during the study period:
  Surgical sterilization: tubal ligation/resection, hysterectomy, vasectomy/resection, etc.
  Intrauterine device or system
  Hormonal contraceptives: progesterone-only or estrogen-progesterone combination oral contraceptives, transdermal contraceptives, depot injections, etc.
  Dual barrier method: combining a male physical barrier (e.g., male condoms) and a female physical barrier (e.g., female condoms, cervical caps, diaphragms, contraceptive sponges) with spermicides (Note: using both male and female condoms is not recommended due to the potential decrease in contraceptive efficacy from physical friction).
Women medically deemed unable to become pregnant may participate in the trial: postmenopausal (no menstruation for at least 24 months), women who have undergone a hysterectomy, salpingectomy, or bilateral oophorectomy.

1. History of previous Helicobacter pylori treatment.
2. Underwent or planning to undergo surgery that affects gastric acid secretion.
3. Diagnosed with Zollinger-Ellison syndrome.
4. History of previous gastrectomy.
5. Patients with uncontrolled severe heart, lung, or liver diseases (screening test showing AST, ALT, ALP > 2 times the upper limit), kidney disease (CCr or GFR < 30), severe uncontrolled diabetes, severe neurologic disorders leading to high comorbidity.
6. Patients with cognitive or intellectual disabilities such as delirium or dementia, making effective communication difficult.
7. Patients who have shown hypersensitivity to potassium-competitive acid blockers, clarithromycin, amoxicillin, or metronidazole.
8. Patients currently taking contraindicated medications with fexuprazan, clarithromycin, amoxicillin, metronidazole (such as atazanavir, nelfinavir, rilpivirine, terfenadine, cisapride, pimozide, astemizole, ergot alkaloids, mizolastine, retinoid-containing products, etc).
9. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
10. Patients with contraindications to antibiotics (clarithromycin, amoxicillin, metronidazole) such as central nervous system infections, electrolyte disturbances (hypokalemia, hypomagnesemia), prolonged QT interval, infectious mononucleosis, hypothyroidism, adrenal insufficiency, alcohol consumption within the past 3 days.
11. History of malignant tumors other than early gastric cancer treated with endoscopic resection within the past 5 years from the screening.
12. Pregnant or breastfeeding women.
13. Patients who have taken histamine receptor blockers (H2 blockers), proton pump inhibitors (PPIs), or potassium-competitive acid blockers (P-CABs) within a week prior to trial drug administration (use of mucosal protectants, gastrointestinal prokinetics, etc., is irrelevant).
14. Patients who have taken bismuth or antibiotics effective for Helicobacter pylori eradication within 4 weeks prior to trial drug administration.
15. Participation in another clinical trial within 30 days before screening, involving the use of trial medication.
16. Others deemed unsuitable for participation in the trial by the investigator.

Eradication rate

Urea breath test on the visit 3

adverse reaction

Visit 3

eradication rate according to CYP2C19 polymorphism

CYP2C19 polymorphism testing on the visit 3