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

NCT06984484 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2026-04-08

No results posted yet for this study

Summary

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 potential performance and tolerability in managing mild to moderate GERD symptoms. These alternatives could address the unmet needs of NERD patients, especially those with a low response to PPIs treatment and provide an option without the potential side effects of prolonged PPIs use. Afluxin® is a class III medical device, containing functional substances (tamarind seed polysaccharide, pea protein and polyacrylic acid), formulated for the treatment of mild to moderate GERD. Preclinical data have shown that Afluxin® is able to create a protective barrier over the gastroesophageal epithelium, preventing reflux damage. In vitro studies suggest that Afluxin® effectively binds to the esophageal and gastric mucosa, reducing abnormal permeability caused by acid reflux. Moreover, in vivo evidence shows that Afluxin® can increase gastric pH, reduce epigastric pain, esophageal damage, and inflammatory markers associated with GERD. Given the encouraging results obtained in preclinical investigations, this study is designed to provide clinical evidence to support the performance and safety of Afluxin® in reducing gastrointestinal symptoms of patients with mild to moderate GERD in a multicenter, randomized, double-blind, parallel-group, Afluxin® stick pack vs. inactive control clinical investigation.

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

DEVICE

Afluxin®

Afluxin® stick pack is an oral suspension to be taken without any liquid 3 times a day after breakfast, lunch and before going to bed, for 7 days.

DRUG

Placebo

Inactive control stick pack is an oral suspension to be taken without any liquid 3 times a day after breakfast, lunch and before going to bed, for 7 days.

Sponsors & Collaborators

  • Devintec Sagl

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-02
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06984484 on ClinicalTrials.gov