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Comparing the efficacy of the bismuth-based quadruple therapy containing a high dose of metronidazole with a concomitant regimen containing clarithromycin for eradicating Helicobacter pylori infection

Comparing the efficacy of the bismuth-based quadruple therapy containing a high dose of metronidazole with a concomitant regimen containing clarithromycin for eradicating Helicobacter pylori infection

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200915048726N3
Enrollment
200
Registered
2023-11-25
Start date
2023-12-23
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

H. pylori infection. Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere

Interventions

Intervention 1: Intervention group: The A group (high dose metronidazole): amoxicillin 1 gr BD, metronidazole 1 gr BD, bismuth 240 mg BD, and pantoprazole 40 mg BD for 14 days. Intervention 2: Interve

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients have H. pylori eradication indication based on endoscopic evidence Patients with positive Rapid urease test Patients with positive histology of H. pylori infection

Exclusion criteria

Exclusion criteria: Age under 18 years Reluctance to participate in the study Pregnancy and lactation Patients taking concomitant anticoagulants, corticosteroids or ketoconazole. Patients with a history of gastric surgery Patients with a history of heart failure, lung disease, chronic kidney failure, liver disease (cirrhosis or chronic hepatitis for any reason), or a history of cancer Consumption of alcohol in any amount The presence of any type of malignancy History of drug allergy to the drugs in this study History of H. pylori eradication regimens at any time before this study

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradicating. Timepoint: At least the eighth week after starting treatment. Method of measurement: stool examination.

Secondary

MeasureTime frame
Drug compliance rate. Timepoint: 8th week of study. Method of measurement: questionnaire.;Severity of drug side effects. Timepoint: 8th week of study. Method of measurement: questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArash Kazemi

Mazandaran University of Medical Sciences

arash_6z@yahoo.com+98 11 3337 4977

Outcome results

None listed

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