Clinical trial NCT06579365: Argentinean Registry on the Management of Helicobacter Pylori Infection
Official title: Argentinean Registry on the Management of Helicobacter Pylori Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: H.Pylori Gastrointestinal Disease
H Pylori Infection
Keywords: H pylori
Lead sponsor: University of Buenos Aires
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infected adult patients by Helicobacter pylori

Brief 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

Detailed description: 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. 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. Recruiter Investigators The Recruiting Investigators must be gastroenterologists attending an adult population with a gastroenterology outpatient clinic that assists H. pylori infected patients. Before acceptance the outpatient clinic must attend, in a clinical routine basis, patients in which H. pylori diagnosis or treatment is indicated. Eradication confirmation tests have to be performed routinely. They will register the study variables of their own routine clinical practice in an e-CRF.

Study Variables Anonymised Patient Identifiers

Province/Centre/Investigator Gender Date of Birth Ethnic Background History and Comorbidity BMI Drug allergies Relevant comorbidities Current concomitant medication Data on Infection Indication for diagnosis and treatment Upper Gastrointestinal tract symptoms Diagnostic Test for current treatment Number and type of previous eradication attempts Prescribed Treatment Drugs Dosage and intakes per day Length of treatment Compliance Adherence to treatment (yes/no \>90%) Probiotics use Adverse Events Type of event, intensity, duration and relation with treatment Treatment withdrawal due to adverse events. Efficacy Eradication (yes/no), test used, and date

Eligibility criteria: Inclusion Criteria:

Infected adult patients by Helicobacter pylori

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Exclusion Criteria:

Pregnant or lactating women Subjects currently taking any antibiotics Administration of antibiotics or bismuth in the preceding 4 weeks or PPI 2 weeks previous Unable or refuse to give consent

Primary outcomes:
measure: Effectiveness of H pylori eradication regimens in the real world
timeFrame: At least 4-6 weeks after the treatment
Secondary outcomes:
measure: Diagnostic methods for H pylori detection and eradication
timeFrame: 90 days
measure: Frecuency of adverse events
timeFrame: 90 days
measure: Effectiveness of the different H pylori treatments according to BMI
timeFrame: 90 days
measure: Compliance rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Ciudad de Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Medicas Alfredo Lanari. Universidad de Buenos Aires
Study officials:
affiliation: Instituto de Investigaciones Médicas Alfredo Lanari. Universidad de Buenos Aires
name: Oscar M Laudanno, MD
role: STUDY_CHAIR
References:
citation: Laudanno O, Ahumaran G, Gollo P, Khoury M, Thome M, Gonzalez P. Tailored Helicobacter pylori eradication therapy in obese patients undergoing bariatric surgery. Rev Esp Enferm Dig. 2021 May;113(5):345-347. doi: 10.17235/reed.2020.7433/2020.