H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy

Soon Chun Hyang University

Status: Completed

Conditions: H. Pylori Infection

Treatments: Drug: H. pylori eradication

Study type: Observational

Funder types: Other

Identifiers

NCT05002595

SCH-HP-2021

Details and patient eligibility

About

The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment.

Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.

Full description

The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.

Enrollment: 270 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gastroscopy can be performed
• H. pylori test and pathological analysis can be performed

Exclusion criteria

• Age < 20 or > 80 years
• Anemia (serum hemoglobin level < 10 g/dL)
• Severe systemic disease
• Advanced chronic liver disease
• Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
• History of H. pylori eradication
• History of gastric surgery
• Recent history of upper gastrointestinal bleeding

Trial design

270 participants in 2 patient groups

Modified quadruple therapy

Description:

pantoprazole 40mg bid, amoxicillin 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 14 days

Treatment:

Drug: H. pylori eradication

Tailored eradication

Description:

pantoprazole 40mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid or pantoprazole 40mg bid, tetracycline 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 7 days

Treatment:

Drug: H. pylori eradication