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Study identifier: NCT06984484 Synced from ClinicalTrials.gov · August 02, 2026
● Recruiting

Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease

Condition: Gastroesophageal Reflux Disease (GERD)  ·  Sponsor: Devintec Sagl

PhaseNA
Planned participants208
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

Gastroesophageal Reflux Disease (GERD) is a chronic condition in which stomach acid flows back into the esophagus, causing irritation and inflammation. GERD is categorized into Nonerosive Reflux Disease (NERD), Erosive Esophagitis (EE), and Barrett's esophagus (BE). Common symptoms include heartburn and acid regurgitation. Lifestyle factors such as smoking, obesity, and Helicobacter pylori infection can increase the risk of developing GERD. The clinical management of GERD typically involves Proton Pump Inhibitors (PPIs) therapy, which, although effective, may not benefit all patients and can be associated with long-term risks. The American College of Gastroenterology (ACG) suggests PPIs discontinuation or on-demand therapy for uncomplicated GERD after an 8-week trial. However, evidence indicates that PPIs are used more frequently, often long-term and in high doses, and not necessarily according to recommendations. Moreover, the availability of Over-The-Counter (OTC) PPIs has led to prolonged use by patients without medical guidance. Concerns have been raised due to potential side effects of long-term PPIs use, including enteric, respiratory, and urinary tract infections, as well as an increased risk of vitamin and mineral deficiencies and osteoporosis. Alternatives to PPIs include Histamine-2 Receptor Antagonists (H2RAs), antacids and alginate-based formulations. Among OTC treatments, medical devices formulated with natural components are also gaining attention for their pot…

This description comes directly from the study's public registry record.

Talk to the study team

Daniela Salvati  ·  +39 3334828012  ·  daniela.salvati@prineos.com

Maria Dini  ·  +39 3383236335  ·  maria.dini@prineos.com

Always discuss trial participation with your own doctor first.

Locations (7)

IRCCS Policlinico San MartinoGenova, ItalyRecruiting
IRCCS Ca' Granda Ospedale Maggiore Policlinico FoundationMilan, ItalyRecruiting
AOU Federico II di NapoliNaples, ItalyRecruiting
Azienda Ospedale Università PadovaPadova, ItalyRecruiting
S. Andrea Ospedale UniversitarioRoma, ItalyRecruiting
Humanitas Research HospitalRozzano (MI), ItalyRecruiting
A.O.U. Città della Salute e della Scienza di TorinoTorino, ItalyRecruiting

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