New natural gel could soothe heartburn without Long-Term drug risks
NCT ID NCT06984484
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study tests whether Afluxin®, a natural gel made from tamarind seed, pea protein, and polyacrylic acid, can reduce heartburn and regurgitation in people with mild-to-moderate GERD. About 208 adults will take the gel or an inactive placebo three times daily for 7 days. The goal is to see if Afluxin® provides faster symptom relief than placebo, offering a potential alternative to long-term acid-reducing drugs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Afluxin® (a mix of tamarind seed polysaccharide, pea protein, and polyacrylic acid)
- What this could lead to
- If it works, this could offer a natural, short-term option for people with mild-to-moderate GERD who want to avoid long-term side effects of standard acid-reducing drugs.
- What could go wrong
- This is a small, early-stage trial (208 people) testing only 7 days of treatment. The results may not apply to severe GERD or long-term use, and the placebo group may also improve.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 208 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female patients, aged ≥ 18 years and ≤ 75 years. 2. 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. 3. 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. 4. Patient has provided written informed consent after being informed of the study procedures and risks prior to any study-related events. 5. Patients are able to understand and adhere to the study procedures. 6. Females of childbearing potential must have a negative urine pregnancy test (dipstick) at Visit 1 and currently use or agree to use consistently and correctly (i.e., perfect use) a highly effective or acceptable effective contraceptive method for the individual subject and her partner(s) throughout the study treatment period. Exclusion Criteria: 1. Patient with hypersensitivity to any Afluxin® or inactive control components. 2. Rhinosinusitis or bronchitis. 3. Patients with a: 1. history and/or 2. symptom profile and/or 3. discovered on endoscopy suggestive of the following: any other Gastrointestinal (GI) disease, erosive GERD, BE, acute peptic ulcer and/or ulcer complications, hiatus hernia with a diameter which exceeds 3 cm, Zollinger-Ellison syndrome, esophageal or gastric cancer, pyloric stenosis, esophageal or gastric surgery, intestinal obstruction, current pernicious anemia, indication for H. pylori eradication therapy, known gastro-intestinal bleeding (hematochezia or hematemesis) within the last 12 months. 4. Patients diagnosed with functional dyspepsia characterized by postprandial distress syndrome (i.e., bothersome postprandial fullness and/or early satiation). 5. Patients with a history of gastro-esophageal surgery, anti-reflux, or bariatric procedure. 6. Presence of any active malignancy (except for non-invasive basal or squamous cell carcinoma of the skin). 7. Patients using any drug that could affect symptoms or affecting the gastrointestinal tract during the last week prior to screening: 1. prokinetics 2. systemic glucocorticosteroids 3. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 8. Patients who are pregnant or lactating. 9. Patients who are enrolled in or have participated in other clinical trials or investigations within 30 days prior to screening. 10. Clinically significant or unstable concurrent diseases whose sequelae or treatment might contraindicate study participation or interfere with the study evaluation parameters, as judged by the Investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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A.O.U. Città della Salute e della Scienza di Torino
RECRUITINGTorino, 10126, Italy
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AOU Federico II di Napoli
RECRUITINGNaples, 80131, Italy
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Azienda Ospedale Università Padova
RECRUITINGPadova, 35128, Italy
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Humanitas Research Hospital
RECRUITINGRozzano (MI), 20089, Italy
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IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
RECRUITINGMilan, 20122, Italy
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IRCCS Policlinico San Martino
RECRUITINGGenova, 16132, Italy
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S. Andrea Ospedale Universitario
RECRUITINGRoma, 00189, Italy
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