NCT06579365 Argentinean Registry on the Management of Helicobacter Pylori Infection
| NCT ID | NCT06579365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Buenos Aires |
| Condition | H.Pylori Gastrointestinal Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2021-05-17 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2021-05-17 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: Infected adult patients by Helicobacter pylori \- 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
Contact & Investigator
Oscar M Laudanno, MD
STUDY CHAIR
Instituto de Investigaciones Médicas Alfredo Lanari. Universidad de Buenos Aires
Frequently Asked Questions
Who can join the NCT06579365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying H.Pylori Gastrointestinal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06579365 currently recruiting?
Yes, NCT06579365 is actively recruiting participants. Contact the research team at oscarlaudanno@gmail.com for enrollment information.
Where is the NCT06579365 trial being conducted?
This trial is being conducted at Ciudad de Buenos Aires, Argentina.
Who is sponsoring the NCT06579365 clinical trial?
NCT06579365 is sponsored by University of Buenos Aires. The principal investigator is Oscar M Laudanno, MD at Instituto de Investigaciones Médicas Alfredo Lanari. Universidad de Buenos Aires. The trial plans to enroll 5,000 participants.