Concomitant Versus Hybrid Regimen for H. Pylori Eradication

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

Summary

10 day concomitant versus 14 day hybrid regimen as first line H. pylori eradication treatment in a high clarithromycin resistance area. A multicenter, randomized, equivalence trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alexandra Hospital, Athens, Greece
• Collaborator: Hellenic Society of Gastroenterology
• Treatments: Amoxicillin; Clarithromycin; Esomeprazole; Metronidazole

Criteria

Inclusion criteria:

• patients of 18 years or older referring for upper GI endoscopy

• infected with H. pylori (verified with 2 out of 3 tests - rapid urease test, histology, culture)

• without previous H. pylori eradication treatment (naïve)

Exclusion criteria are:

• age below 18 years

• presence of severe co-morbidities (i.e. liver cirrhosis, renal failure, haematological, neurological, psychiatric, cardiovascular or pulmonary disease)

• previous gastric surgery

• gastric malignancies

• Zollinger-Elisson syndrome

• known allergy or other contraindications to the study medications

• previous H. pylori treatment

• use of antibiotics , bismuth salts , NSAIDS or aspirin in the preceding month

• use of PPI in the preceding two weeks

• not willing to participate in the study

• pregnant or lactating women