Dual vonoprazan and amoxicillin therapy for Helicobacter pylori infection in Uruguay

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults with Helicobacter pylori infection treated at Uruguayan tertiary centers, the study compares a vonoprazan-amoxicillin dual therapy given for 14 days to the traditional non-bismuth quadruple regimen (omeprazole, clarithromycin, amoxicillin, and metronidazole) given for 14 days. The primary goal is to see if the dual therapy reduces the frequency and severity of adverse events while achieving adequate eradication. The trial is interventional and randomized, conducted at multiple Uruguayan sites, with specific eligibility criteria including confirmed infection and no prior eradication therapy. The results could influence first-line treatment choices where clarithromycin resistance is a consideration and access to alternative drugs is limited.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 to 75 years attending one of the four participating tertiary-care centres
* Helicobacter pylori infection confirmed by at least one of the following: gastric histology, endoscopic rapid urease test, stool antigen test, serology, or urea breath test
* Indication for eradication therapy according to the Maastricht VI/Florence consensus
* Written informed consent

Exclusion Criteria:

* \* Known allergy or hypersensitivity to any of the study drugs (vonoprazan, amoxicillin, omeprazole, clarithromycin or metronidazole).
* Previous Helicobacter pylori eradication treatment.
* Antibiotic use within the month before enrolment.
* Use of histamine H2-receptor antagonists, proton pump inhibitors or potassium-competitive acid blockers within the two weeks before enrolment.
* Pregnancy.
* Previous gastric resection.
* Unwillingness to participate.

Where it's running

• Asistencial Médica - Hospital Cantegril
  Maldonado, Departamento de Maldonado, Uruguay Recruiting
• Hospital de Clínicas "Dr. Manuel Quintela"
  Montevideo, Montevideo Department, Uruguay Recruiting
• Cooperativa Médica de Paysandú
  Paysandú, Paysandú Department, Uruguay Recruiting
• Dirección Nacional de Sanidad Policial
  Montevideo, Montevideo Department, Uruguay Not yet recruiting

Study contacts

• Study coordinator: Manuela Arocena, Resident
• Email: manuela.arocena@gmail.com
• Phone: 0059898504008

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dual-drug therapy with linlarase glutarate and amoxicillin vs bismuth quadruple therapy for first-line Helicobacter pylori eradication

  This trial tests whether a dual-drug regimen of linlarase glutarate capsules plus amoxicillin can match the effectiveness of a standard bismuth-containing quadruple therapy for first-line Helicobacter pylori eradication.

  Recruiting at 24 sites Phase 4 Xijing Hospital of Digestive Diseases · Zhengzhou, Henan and 23 other locations · NCT07897994

• Feasibility of FFPE qPCR to Detect H. pylori and Clarithromycin Resistance

  This study tests whether tissue samples already collected during gastroscopy can be used with qPCR to find Helicobacter pylori and its clarithromycin resistance.

  Recruiting Clinique Bizet · Paris · NCT07821294

• Adding bismuth to vonoprazan‑amoxicillin therapy for H. pylori

  This study will test whether adding bismuth to a 14-day vonoprazan‑amoxicillin regimen improves H. pylori cure rates in adults who have never had eradication therapy.

  Recruiting Phase 3 National Taiwan University Hospital · Taipei · NCT07576959

• Endoscopic screening for H. pylori, intestinal metaplasia, and Barrett's mucosa during screening colonoscopy

  This project will try adding a gastroscopy with biopsies to routine screening colonoscopy to see how often H. pylori and early stomach changes appear in adults without upper GI symptoms.

  Recruiting Sigmund Freud PrivatUniversitat · Vienna · NCT07346521

• Registry for managing Helicobacter pylori infection in Shandong Province

  This registry will collect real-world information on H. pylori treatments given to adults in Shandong Province to see which approaches work best and are safest.

  Recruiting Qilu Hospital of Shandong University · Jinan, Shandong and 1 other locations · NCT07335406

• Treating H. pylori infection to help metabolic syndrome by changing gut bacteria.

  This study will see if adding a probiotic or berberine to standard H. pylori treatment helps adults with H. pylori infection and newly diagnosed metabolic syndrome improve blood sugar, cholesterol, weight, and other metabolic measures.

  Recruiting Phase 4 Nanjing First Hospital, Nanjing Medical University · Nanjing, Jiangsu · NCT07306988

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.