Skip to content

Comparison of 5-day and 10-day levofloxacin based triple regimen to eradication of helicobacter pylori: An open-label randomized clinical trial

Comparison of 5-day and 10-day levofloxacin based triple regimen to eradication of helicobacter pylori: An open-label randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250426065481N1
Enrollment
120
Registered
2025-05-27
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Helicobacter pylori infection. Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters

Interventions

Intervention 1: Intervention group: 5-day treatment group regimen: Amoxicillin: 1000 mg twice daily, Levofloxacin 500 mg once daily (Tavanex®, abidi pharma), Pantoprazole 40 mg twice daily (abidi Phar

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: All individuals aged 18 to 60 with a histologically confirmed Helicobacter pylori infection The patient's consent to participate in the study

Exclusion criteria

Exclusion criteria: Prior treatment for H. pylori eradication Severe and chronic medical conditions Pregnant women History of NSAID, antibiotic, or PPI use within the last 30 days Prior stomach surgery Severe kidney dysfunction [serum creatinine >2 mg/dL] Severe liver dysfunction Known hypersensitivity to levofloxacin, amoxicillin, or pantoprazole Gastric cancer

Design outcomes

Primary

MeasureTime frame
Helicobacter Pylori infection eradication. Timepoint: Five weeks after completing treatment (two weeks after stopping pantoprazole). Method of measurement: Helicobacter pylori stool antigen test.

Secondary

MeasureTime frame
Adverse effect- Constipation. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone.;Adverse effect- Diarrhea. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone.;Adverse effect- Nausea. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone.;Adverse effect- Vomiting. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone.;Adverse effect- Abdominal pain. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone.;Adverse effect- Heartburn. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone.;Adverse effect- Metallic taste. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone.;Adverse effect- Flatulence. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone.;Adverse effect- Dizziness. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone.;Adverse effect- Low appetite. Timepoint: Before starting the study, 5 days after starting treatment, and at the end of treatment. Method of measurement: Ask the patient in person or by phone.;Adverse effect- Headache. Timepoint: Before starting the study, 5 days after starting treatment, a

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmin Vahedi

Babol University of Medical Sciences

Dr.aminvahedi@gmail.com+98 11 4324 0633

Outcome results

None listed

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