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Comparison of 3 or 4 times daily amoxicillin administration in a triple therapy for Helicobacter pylori eradication.

Comparison of the effectiveness of administering amoxicillin 3 or 4 times daily in triple-drug regimens containing esomeprazole, bismuth, and amoxicillin for eradication of Helicobacter pylori in patients with this infection

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240507061691N1
Enrollment
200
Registered
2025-02-09
Start date
2025-02-03
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

Interventions

Intervention 1: First intervention group: Patients in this group receive amoxicillin capsules (Farabi Company) 1 gram half an hour after breakfast, lunch and dinner
bismuth subcitrate tablets (Pursina Company) 240 mg half an hour before breakfast, lunch and dinner
and esomeprazole capsules (Abidi Company) 40 mg half an hour before breakfast and dinner for 14 days. Intervention 2: Second intervention group: Patients in this group receive amoxicillin capsules (Fa
and esomeprazole capsules (Abidi Company) 40 mg half an hour before breakfast and dinner for 14 days.

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Subjects with dyspepsia who undergo endoscopy Biopsy during endoscopy confirms the presence of Helicobacter pylori For the first time, a Helicobacter pylori eradication regimen is prescribed for them.

Exclusion criteria

Exclusion criteria: Unwillingness to participate in the study Patients who are taking anticoagulants, corticosteroids or ketoconazole at the same time Patients who have a history of stomach surgery Patients who have 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 alcoholic beverages in any amount The presence of any type of malignancy History of drug sensitivity to the drugs of this study History of H. pylori eradication regimens at any time Pregnancy and breastfeeding

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate in treatment groups. Timepoint: 4 weeks after completion of treatment. Method of measurement: Stool Helicobacter Pylori Antigen.

Secondary

MeasureTime frame
Drug compliance rate in treatment groups. Timepoint: Fifteenth day from the start of treatment. Method of measurement: The medication bag is checked and if more than 90% of the medication has been consumed, it is considered excellent acceptance.;Side effects in treatment groups. Timepoint: If during treatment (14 days) there are severe complications (drug complications prevent daily life), the patient will make a phone call to the clinical caregiver. If there are no severe complications, the patient will be visited on day 15 and complications will be assessed. Method of measurement: Phone calls and visit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud Hosseini

Mazandaran University of Medical Sciences

masoud.hosseini@mazums.ac.ir+98 11 3337 7178

Outcome results

None listed

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