Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDevintec Sagl
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients, aged ≥ 18 years and ≤ 75 years.
Evidence of symptomatic GERD: patients with ongoing heartburn and/or regurgitation (with or without dyspepsia symptoms of epigastric pain and/or burning) of at least mild to moderate severity or experienced during the least 7 days before starting the treatment, as assessed on a clinical basis by the Investigator.
Patients not pre-treated with PPIs, even for problems different from GERD (e.g., gastroprotection, PPI-based triple or quadruple therapy for eradication of H. pylori), H2RAs, and/or with antiacids, alginates or medical devices made of substances (i.e., substance-based medical devices to treat GERD, gastroesophageal reflux and similar conditions) in the last week prior to screening.
Patient has provided written informed consent after being informed of the study procedures and risks prior to any study-related events.
Disqualifiers
Patient with hypersensitivity to any Afluxin® or inactive control components.
Rhinosinusitis or bronchitis.
history and/or
symptom profile and/or
Trial design
Design model
Parallel
Treatments tested in this trial
Afluxin®
DeviceAfluxin® 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.
Placebo
DrugInactive 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.
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: Afluxin®Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Assess the superiority of a 7-day treatment course with Afluxin® over inactive control in terms of difference between treatment groups in terms of proportion of responders
The primary endpoint is the difference between treatment groups (Afluxin® and placebo) in terms of proportion of responders, defined as patients who report a reduction in the GERD dimension of the RDQ (Reflux Disease Questionnaire) equal to 1.5 points (clinically significant difference, according to Wilkinson et al., 2019), between baseline and the end of the 7-day treatment. In the RDQ questionnaire validated in Italian language, patients are asked to rate GERD-related symptoms they have been experiencing over the past 7 days. The questionnaire consists of 12 items to report the frequency and severity of heartburn, regurgitation and dyspepsia. In this study the two subscales for heartburn and regurgitation will be combined into the GERD dimension. Symptom frequency and severity will be measured on 6-point scales (ranging from 0=none to 5 =daily/severe).
Time frame
From enrollment to the end of the 7-day treatmentSecondary outcomes
1
RDQ GERD dimension, including single item scores
GERD dimension evaluated through the RDQ (Reflux Disease Questionnaire) and evaluation of the single item scores, at the baseline and at the end of the 7-day treatment. In the RDQ questionnaire validated in Italian language, patients are asked to rate GERD-related symptoms they have been experiencing over the past 7 days. The self-assessed questionnaire will consist of 12 items to report the frequency and severity of heartburn, regurgitation and dyspepsia. The two subscales for heartburn and regurgitation will be combined into the GERD dimension. Symptom frequency and severity will be measured on 6-point scales (ranging from 0=none to 5 =daily/severe).
Time frame
Baseline and at the end of the 7-day treatment2
RDQ dyspepsia dimension total and single item scores
Dyspepsia dimension evaluated through the RDQ (Reflux Disease Questionnaire) total and single item scores, at the baseline and at the end of the 7-day treatment. In the RDQ questionnaire validated in Italian language, patients are asked to rate GERD-related symptoms they have been experiencing over the past 7 days. The self-assessed questionnaire will consist of 12 items to report the frequency and severity of heartburn, regurgitation and dyspepsia (burning/pain in the upper stomach). Symptom frequency and severity will be measured on 6-point scales (ranging from 0=none to 5 =daily/severe).
Time frame
Baseline and at the end of the 7-day treatment3
Total and single item scores of the Reflux Symptom Index (RSI)
Total and single item scores of the Reflux Symptom Index (RSI) at baseline and at the end of the 7-day treatment, assessing the severity of Laryngopharyngeal Reflux (LPR) symptoms. The RSI validated in Italian language, will be used for the evaluation of LPR symptoms that patients have been experiencing within the last month. The RSI examines 9 items, to be scored from 0 (no problem) to 5 (severe problem), with a higher score indicating a higher severity of the symptom (range of total score: 0-45) .
Time frame
Baseline and at the end of the 7-day treatment4
Severity of GERD cardinal symptoms (i.e., heartburn and regurgitation)
Severity of GERD cardinal symptoms (i.e., heartburn and regurgitation) throughout the 7-day treatment, as self-assessed daily by patients using a 7-point Likert scale ranging from 1 = no discomfort to 7 = very severe discomfort.
Time frame
Throughout the 7-day treatmentSponsors and contacts
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Source ClinicalTrials.gov