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Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection

Phase 4
Completed
Conditions
Helicobacter Infection
Interventions
Drug: Lanzol
Drug: Tinafas
Drug: Klacid
Drug: Iramox
Drug: Tavanex
Registration Number
NCT02711176
Lead Sponsor
Zahra Vahdat Shariatpanahi
Brief Summary

This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.

Detailed Description

Multiple regimens have been evaluated for H. pylori therapy in randomized controlled trials The treatment regimen that is selected must be effective, but considerations such as cost, side effects, and ease of administration should also be taken into account. Despite the number of studies, the optimal therapeutic regimen has not yet been defined.

The regimen most commonly recommended for first line treatment of H. pylori is triple therapy with a PPI, amoxicillin and clarithromycin for 14 days. However, the multi-drug application is associated with remarkable side effects and it is not uncommon not to be able to complete a treatment course. Thus, treatment failure is associated with H. pylori strains that are resistant to the commonly used antibiotics. This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
212
Inclusion Criteria
  • The patients who proved H. pylori infection following three methods

    • Positive rapid urease test
    • Histologic evidence of H. pylori by modified Giemsa staining
    • Positive stool Antigen Test
Exclusion Criteria
  • Patients who received eradication therapy for H. pylori infection, previously
  • H. pylori eradication failure because of poor compliance
  • The administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
  • Advanced gastric cancer or other malignancy
  • Abnormal liver function or liver cirrhosis
  • Abnormal renal function or chronic kidney disease
  • Other severe concurrent diseases
  • Previous allergic reactions to the study drugs
  • Pregnant or lactating women

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lanzol & Klacid &IramoxLanzolPatients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days
Tavanex & Nexium & TinafasTinafasPatients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"
Lanzol & Klacid &IramoxIramoxPatients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days
Tavanex & Nexium & TinafasTavanexPatients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"
Lanzol & Klacid &IramoxKlacidPatients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days
Tavanex & Nexium & TinafasNexiumPatients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"
Primary Outcome Measures
NameTimeMethod
The rate of H.pylori eradication42 days after study completion

Breath Urea Test

Secondary Outcome Measures
NameTimeMethod
Drug Compliancewithin the first week after study completion

Interview

Trial Locations

Locations (1)

Ilam University of Medical Scienvc

🇮🇷

Ilam, Iran, Islamic Republic of

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