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Study on Reducing Proton Pump Inhibitor Use in Patients with Heartburn, Reflux, or Dyspepsia: Comparing On-Demand Use, Alginate Therapy, and Gradual Dose Reduction

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on finding the best way to stop using a type of medication called proton pump inhibitors (PPIs) in people who have been taking them for a long time without a clear reason. PPIs are often used to treat conditions like heartburn, reflux, and functional dyspepsia, which is a type of indigestion. The study will compare three different methods to stop using PPIs. The first method involves using PPIs only when needed, known as on-demand use. The second method replaces PPIs with a different type of medication called an alginate formulation, which helps to protect the stomach lining. The third method is the traditional approach, which gradually reduces the PPI dose over time.

The purpose of the study is to determine which of these methods is most effective in helping patients stop using PPIs while still managing their symptoms. Participants in the study will be randomly assigned to one of the three methods and will be monitored to see how well they do with their assigned method. The study will look at how many people successfully stop using PPIs, how satisfied they are with their treatment, and whether they are willing to continue with the new method. The study will also track how often participants use PPIs during the follow-up period.

This trial is expected to provide valuable information on the best strategies for safely reducing or stopping the use of PPIs in patients who do not have a long-term need for them. The study will run for a set period, and participants will have regular check-ins to assess their progress and any changes in their symptoms. The findings from this study could help improve the way PPIs are prescribed and used in the future, ensuring that patients receive the most appropriate care for their condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the study, you will be assigned to one of three groups. Each group will follow a different strategy to reduce or stop the use of proton pump inhibitors (PPIs), which are medications used to reduce stomach acid.

  2. Step 2

    Group assignment

    Group A will use PPIs only when needed, known as on-demand use.

    Group B will replace PPI therapy with a medication containing sodium hydrogen carbonate, calcium carbonate, and sodium alginate, which helps manage symptoms like heartburn and reflux.

    Group C will gradually reduce the PPI dose through a fixed schedule, known as intermittent intake.

  3. Step 3

    Medication administration

    If you are in Group A, take your PPI medication only when you experience symptoms.

    If you are in Group B, take the replacement medication as directed, which may be in the form of an oral suspension.

    If you are in Group C, follow the schedule provided to gradually decrease your PPI dosage.

  4. Step 4

    Follow-up visits

    Throughout the trial, you will have regular follow-up visits. During these visits, your progress will be evaluated based on your use of PPIs, your satisfaction with the treatment, and your willingness to continue with the treatment.

  5. Step 5

    Evaluation of outcomes

    The success of the treatment will be determined by the percentage of patients achieving a successful therapeutic outcome, which includes reduced PPI use, treatment satisfaction, and willingness to continue the treatment.

  6. Step 6

    End of trial

    The trial is expected to end by August 29, 2025. At the end of the trial, the results will be analyzed to determine the most effective strategy for reducing or stopping PPI use.

Who can join the trial?

3 criteria

  • Adults who are older than 18 years old.
  • Both males and females can participate.
  • Patients who have been using proton pump inhibitors (PPIs) every day for more than 12 weeks without a specific medical reason for long-term use. PPIs are medications that reduce stomach acid.

Who cannot join the trial?

3 criteria

  • Patients with **functional dyspepsia**, which is a type of indigestion that doesn't have a clear cause, cannot participate.
  • Patients experiencing **heartburn**, a burning feeling in the chest, are excluded.
  • Patients with **reflux**, where stomach acid flows back into the tube connecting your mouth and stomach, are not eligible.
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Investigated drugs

  • Proton Pump Inhibitors (PPIs)

    are medications that reduce the amount of acid produced in the stomach. They are often used to treat conditions like heartburn, acid reflux, and stomach ulcers. In this trial, the focus is on patients who have been using PPIs for a long time without a clear reason to continue. The study is exploring different ways to stop or reduce the use of PPIs safely.

  • Alginate Formulation

    is a type of medication that helps manage symptoms of acid reflux by forming a protective barrier on top of the stomach contents. This barrier helps prevent acid from flowing back into the esophagus, which can cause discomfort. In this trial, alginate is being tested as an alternative to PPIs to see if it can effectively manage symptoms when patients stop using PPIs.

What is already known about the treatment

Proton Pump Inhibitors (PPIs) – PPIs are typically taken orally in the form of tablets or capsules and are used to reduce stomach acid production. They are commonly prescribed for conditions like functional dyspepsia, heartburn, and reflux. In medical literature, PPIs are well-established for their effectiveness in managing these conditions, but there is ongoing research to optimize their use, especially in patients without a clear need for long-term therapy. PPIs work by blocking the enzyme in the stomach lining responsible for acid production, providing relief from acid-related symptoms. They belong to the pharmacological class of acid-suppressing medications.

Investigated diseases

  • Functional dyspepsia

    Functional dyspepsia is a common disorder characterized by persistent or recurring pain or discomfort in the upper abdomen. It is not caused by any identifiable structural or biochemical abnormalities. Symptoms often include bloating, nausea, and feeling full quickly when eating. The condition can fluctuate, with periods of symptom relief followed by flare-ups. It is considered a functional gastrointestinal disorder, meaning the symptoms are real but not linked to any visible disease or damage in the digestive system.

  • Heartburn

    Heartburn is a burning sensation in the chest, just behind the breastbone, often after eating. It occurs when stomach acid backs up into the esophagus, causing irritation. The sensation can last for a few minutes to several hours and may worsen when lying down or bending over. Heartburn is a common symptom of gastroesophageal reflux disease (GERD) but can also occur occasionally in people without GERD. It is often accompanied by a sour or bitter taste in the mouth.

  • Gastroesophageal reflux disease (GERD)

    Gastroesophageal reflux disease (GERD) is a chronic condition where stomach acid frequently flows back into the esophagus, leading to irritation. This backwash, or reflux, can cause symptoms such as heartburn, regurgitation, and difficulty swallowing. Over time, GERD can lead to inflammation of the esophagus, known as esophagitis. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more severe, persistent issues. GERD is often managed by lifestyle changes and medications to reduce acid production.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502375-37-00Protocol codePEPPEREstimated enrolment745 patientsSponsorUZ Leuven

sourced from the EU Clinical Trials Register and site verification

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