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New natural gel could soothe heartburn without Long-Term drug risks

NCT ID NCT06984484

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 208 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • A.O.U. Città della Salute e della Scienza di Torino

    RECRUITING

    Torino, 10126, Italy

  • AOU Federico II di Napoli

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedale Università Padova

    RECRUITING

    Padova, 35128, Italy

  • Humanitas Research Hospital

    RECRUITING

    Rozzano (MI), 20089, Italy

  • IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

    RECRUITING

    Milan, 20122, Italy

  • IRCCS Policlinico San Martino

    RECRUITING

    Genova, 16132, Italy

  • S. Andrea Ospedale Universitario

    RECRUITING

    Roma, 00189, Italy

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