Argentinean Registry on the Management of Helicobacter Pylori Infection (ArgReg-Hp)

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

Study Overview

• Status: Recruiting
• Conditions: H Pylori Infection; H.Pylori Gastrointestinal Disease

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

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Oscar M Laudanno, MD; Phone Number: 5491141693149; Email: oscarlaudanno@gmail.com
• Study Contact Backup: Name: Gabriel E Ahumarán, MD; Phone Number: 5491162955388; Email: drgabrielahumaran@gmail.com

Study Locations

• Argentina
  • Ciudad de Buenos Aires, Argentina, 1427
    • Recruiting
    • Instituto de Investigaciones Medicas Alfredo Lanari. Universidad de Buenos Aires
    • Contact: Oscar M Laudanno, MD; Phone Number: 5491141693149; Email: oscarlaudanno@gmail.com
    • Contact: Gabriel E Ahumarán, MD; Phone Number: 5491162955388; Email: drgabrielahumaran@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infected adult patients by Helicobacter pylori

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Buenos Aires
• Investigators: Study Chair: Oscar M Laudanno, MD, Instituto de Investigaciones Medicas Alfredo Lanari. Universidad de Buenos Aires

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2034

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: H pylori
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: Registro Argentino H pylori

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The plan is to share information during Digestive Congress and to publicate the results
• IPD Sharing Time Frame: As soon as we have new data
• IPD Sharing Access Criteria: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No