Clinical trial NCT02711176: Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection
Official title: Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Infection
Lead sponsor: Ilam University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of H.pylori eradication
timeFrame: 42 days after study completion
Secondary outcomes:
measure: Drug Compliance
timeFrame: within the first week after study completion
Other outcomes:
Locations:
city: Ilam
country: Iran, Islamic Republic of
facility: Ilam University of Medical Scienvc
Study officials:
affiliation: Assistant Professor, Ilam University of Medical Sciences,Head of Faculty of Medicine
name: Shaahin Shahbazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shahbazi S, Vahdat Shariatpanahi Z. Comparison between daily single-dose triple therapy and conventional triple therapy on patient compliance and Helicobacter pylori eradication: A randomized controlled trial. Indian J Gastroenterol. 2018 Nov;37(6):550-554. doi: 10.1007/s12664-018-0916-z. Epub 2019 Jan 12.