Argentinean Registry on the Management of Helicobacter Pylori Infection
NCT Number: NCT06579365
Acronym: ArgReg-Hp
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: H.Pylori Gastrointestinal Disease|H Pylori Infection
Sponsor: University of Buenos Aires
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-05-17
Completion Date: 2034-01-01
Locations: Instituto de Investigaciones Medicas Alfredo Lanari. Universidad de Buenos Aires, Ciudad de Buenos Aires, 1427, Argentina

Summary:
Helicobacter pylori (H pylori) is the main cause of chronic gastritis and peptic ulcer disease. In addition, is the main risk factor for gastric adenocarcinoma and mucosa-associated lymphoid tissue lymphoma. It is estimated that around 50% of the Argentinean population is infected with H pylori. The optimal management of H pylori remains unclear. In Argentina, most treatments are prescribed on an empiric basis, unaware of the bacterial antibiotic resistance profile.

Meta-analysis showed that susceptibility-guided treatment is not better than empirical treatment in first and second line treatment therapy if the most effective local regimens are prescribed. Updated information concerning local data is needed to design the best strategy to treat H pylori infection in order to reach high eradication rates and to introduce the principles of antimicrobial stewardship to reduce inappropriate antibiotic use.

The Argentinean Registry on H pylori (ArgReg-Hp) management was launched in May 2021 in order to obtain a large and representative sample of routine clinical practice of Argentinean gastroenterologist. Its main focus was to identify therapies that are highly effective and can be used empirically. Test of cure data is a surrogate method for susceptibility testing and resistance Primary aim To obtain a database registering systematically of a large and representative sample of routine clinical practice of Argentinean gastroenterologists in order to produce descriptive studies of the management of H. pylori infection.

Secondary aims To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori.

The Argentinean Registry on H pylori management is a National , multicenter, prospective, non interventional registry recording data on H pylori management since May 2021. The ArgReg-Hp is promoted by Instituto de Investigaciones Médicas Alfredo Lanari (IDIM), Universidad de Buenos Aires and Club Argentino Estómago y duodeno (CADED).

Ethics: ArgReg-Hp was approved by the Ethics Committee IDIM, University of Buenos Aires as the reference IRB, and was approved by each center participant

Primary Outcome Measures: Effectiveness of H pylori eradication regimens in the real world, Eradication (yes or No). Negative Urea Breath Test or stool antigen, At least 4-6 weeks after the treatment
Secondary Outcome Measures: Diagnostic methods for H pylori detection and eradication, Test used, 90 days|Frecuency of adverse events, Any possible adverse events during the treatment period. Treatment withdrawal due to adverse events, 90 days|Effectiveness of the different H pylori treatments according to BMI, BMI, 90 days|Compliance rate, Compliance was defined as good when subjects had taken more than 90% of the total medication, 90 days