Clinical Trial

Pylori Duo for Adjunctive Treatment and Prevention of Recurrence of Helicobacter Pylori Infection

Not Yet Recruiting
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Summary
This randomized, double-blind, placebo-controlled, single-center clinical trial will evaluate the efficacy and safety of Pylori Duo as an adjunctive treatment in adult patients with confirmed Helicobacter pylori infection. Approximately 140 participants will be randomized to receive standard quadruple therapy (omeprazole plus Pylera®) combined with either placebo or Pylori Duo for 10 days, followed by placebo or Pylori Duo for 3 months. The primary objective is to assess the effect of Pylori Duo on gastrointestinal adverse effects associated with standard eradication therapy. Secondary objectives include assessment of H. pylori eradication, recurrence at 3 and 12 months, gastrointestinal symptoms, quality of life, and safety.
Trial Details
NCT Number NCT07729293
Lead Sponsor Gala Servicios Clinicos S.L.
Conditions Helicobacter Pylori Infection, Dyspepsia, Gastrointestinal Adverse Effects
Enrollment 140 participants
Start Date 2026-08-31
Primary Completion 2027-10-07 (estimated)
Study Completion 2028-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-27