Comparison of the Efficacy of a Triple Therapy Regimen Containing High-Dose Esomeprazole, Bismuth, and Amoxicillin with the Standard Bismuth-Based Quadruple Therapy in the Treatment of Helicobacter pylori Infection

Comparison of a triple-drug regimen with a high dose of esomeprazole, bismuth, and amoxicillin with the standard 4-drug regimen containing bismuth in the treatment of Helicobacter pylori

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251001067450N1

Enrollment

216

Registered

2025-10-26

Start date

2025-11-05

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

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

Interventions

Intervention 1: Group 1: Bismuth-containing Quadruple TherapyDrug composition and dosage:Bismuth subcitrate 120 mg, 2 tablets every 8 hoursClarithromycin 500 mg, every 12 hoursAmoxicillin 1 g, every 1

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age Presenting with gastrointestinal symptoms With gastritis confirmed by esophagogastroduodenoscopy (EGD)

Exclusion criteria

Exclusion criteria: Patients with gastrointestinal bleeding and peptic ulcer Pregnant or breastfeeding women Patients who have previously received eradication therapy for Helicobacter pylori Patients who have previously undergone gastric surgery Patients with malignant neoplasms or those with other severe comorbid diseases

Design outcomes

Primary

Measure	Time frame
Eradication rate of Helicobacter pylori. Timepoint: Baseline: At enrollment ? demographic data and endoscopic findingsDuring treatment: Monitoring of compliance and adverse drug reactions (daily/weekly)End of treatment: At the completion of the two-week therapyFollow-up: Six weeks after the end of therapy (at least two weeks off PPI), for assessment of Helicobacter. Method of measurement: Study outcomes are measured using the following tools: H. pylori eradication assessed by stool antigen test, medication adherence evaluated by pill count, adverse events and drug tolerability recorded through patient interviews, and endoscopic findings including gastritis, erosion, and nodular changes assessed via an endoscopy questionnaire.	—

Measure

Time frame

Eradication rate of Helicobacter pylori. Timepoint: Baseline: At enrollment ? demographic data and endoscopic findingsDuring treatment: Monitoring of compliance and adverse drug reactions (daily/weekly)End of treatment: At the completion of the two-week therapyFollow-up: Six weeks after the end of therapy (at least two weeks off PPI), for assessment of Helicobacter. Method of measurement: Study outcomes are measured using the following tools: H. pylori eradication assessed by stool antigen test, medication adherence evaluated by pill count, adverse events and drug tolerability recorded through patient interviews, and endoscopic findings including gastritis, erosion, and nodular changes assessed via an endoscopy questionnaire.

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Secondary

Measure	Time frame
Adverse drug reactions: All patient-reported symptoms including abdominal bloating, abdominal pain, nausea, vomiting, bitter taste, constipation, dizziness, headache, epigastric pain, general weakness, halitosis, oral ulcers, skin rash, and drowsiness.Treatment compliance: Percentage of medication taken based on pill count; non-adherence is defined as <80% of prescribed doses consumed. Timepoint: Baseline: At study enrollment ? collection of demographic data and endoscopic findings.During Treatment: Monitoring patient compliance and recording adverse drug reactions (via interviews or weekly/daily questionnaires).End of Treatment: At the completion of the two-week therapy, initial assessment of compliance and adverse effects.Follow-up: Six weeks after the end of therapy (at least two weeks off PPI) to assess Helicobacter pylori eradication using the stool antigen test. Method of measurement: Study outcomes are measured using the following tools: H. pylori eradication assessed by stool antigen test, medication adherence evaluated by pill count, adverse events and drug tolerability recorded through patient interviews, and endoscopic findings including gastritis, erosion, and nodular changes assessed via an endoscopy questionnaire.	—

Measure

Time frame

Adverse drug reactions: All patient-reported symptoms including abdominal bloating, abdominal pain, nausea, vomiting, bitter taste, constipation, dizziness, headache, epigastric pain, general weakness, halitosis, oral ulcers, skin rash, and drowsiness.Treatment compliance: Percentage of medication taken based on pill count; non-adherence is defined as <80% of prescribed doses consumed. Timepoint: Baseline: At study enrollment ? collection of demographic data and endoscopic findings.During Treatment: Monitoring patient compliance and recording adverse drug reactions (via interviews or weekly/daily questionnaires).End of Treatment: At the completion of the two-week therapy, initial assessment of compliance and adverse effects.Follow-up: Six weeks after the end of therapy (at least two weeks off PPI) to assess Helicobacter pylori eradication using the stool antigen test. Method of measurement: Study outcomes are measured using the following tools: H. pylori eradication assessed by stool antigen test, medication adherence evaluated by pill count, adverse events and drug tolerability recorded through patient interviews, and endoscopic findings including gastritis, erosion, and nodular changes assessed via an endoscopy questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmin sabaghan

Ahvaz University of Medical Sciences

sabbaghanamin@yahoo.com+98 61 3332 5431

Outcome results

None listed

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