An observational study in H.Pylori Gastrointestinal Disease and H Pylori Infection, sponsored by University of Buenos Aires. Recruiting at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-30.
Sponsored by University of Buenos Aires · Observational
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
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
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →University of Buenos Aires is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Infected adult patients by Helicobacter pylori
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
Effectiveness of H pylori eradication regimens in the real world
Eradication (yes or No). Negative Urea Breath Test or stool antigen
Time frame: At least 4-6 weeks after the treatment
Diagnostic methods for H pylori detection and eradication
Test used
Time frame: 90 days
Frecuency of adverse events
Any possible adverse events during the treatment period. Treatment withdrawal due to adverse events
Time frame: 90 days
Effectiveness of the different H pylori treatments according to BMI
BMI
Time frame: 90 days
Compliance rate
Compliance was defined as good when subjects had taken more than 90% of the total medication
Time frame: 90 days
Plan to share: Yes — The plan is to share information during Digestive Congress and to publicate the results
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