Argentinean Registry on the Management of Helicobacter Pylori Infection

NCT06579365 | Recruiting DMC

• 1 other identifier: Registro Argentino H pylori
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Conditions

H.Pylori Gastrointestinal Disease; H Pylori Infection

Keywords

H pylori

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Diagnostic methods for H pylori detection and eradication

  90 days

• Frecuency of adverse events

  90 days

• Effectiveness of the different H pylori treatments according to BMI

  90 days

• Compliance rate

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Infected adult patients by Helicobacter pylori

You may qualify if:

• Infected adult patients by Helicobacter pylori

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Buenos Aires: lead

Study Sites (1)

Instituto de Investigaciones Medicas Alfredo Lanari. Universidad de Buenos Aires

Ciudad de Buenos Aires, 1427, Argentina

RECRUITING

Related Publications (1)

• 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.

  PMID: 33244981 RESULT

Related Links

• Instituto de Investigaciones Médicas Alfredo Lanari. University of Buenos Aires

Study Officials

• Oscar M Laudanno, MD

  Instituto de Investigaciones Médicas Alfredo Lanari. Universidad de Buenos Aires

  STUDY CHAIR

Central Study Contacts

Oscar M Laudanno, MD

CONTACT

5491141693149; oscarlaudanno@gmail.com

Gabriel E Ahumarán, MD

CONTACT

5491162955388; drgabrielahumaran@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Gastroenterology Department. Institute of Medical Research A Lanari, University of Buenos Aires. Faculty of Medicine

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 30, 2024
• Study Start: May 17, 2021
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2034
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: As soon as we have new data
• Access Criteria: Undecided

Locations

AR (1)