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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Maison Médicale des Riches Claires clinical practice center Brussels Belgium
Spectrummed Saint-Gilles Belgium
Cabinet dr. Spoden Ottignies-Louvain-La-Neuve Belgium
Dr. Marie-Hélène Lanthier-Landenne Schaerbeek Belgium
Huisartsenpraktijk Kerkstraatje clinical practice center Kortrijk Belgium
Doktershuis General Practice Center Bilzen Belgium
Mbfaqxkl Mechelen Belgium
Wsw Dr Bxnboif Brugge Belgium
Mljmwn Mzfcoojcrf Rtkjbyf Ransart Belgium
Hutzptccmj Ppof ceiqduqa peyesrvs cqajfd Leuven Belgium
Hkmttgumqjknlicvuh di lyjiq cvxmzdgm pepploju cbjpgv Lebbeke Belgium
Mjtnkt ckdxatlx peaxikcy cbzhsn Chaumont-Gistoux Belgium
Dtwixg Atihnm Dx Pbenscu cllpuisy pugnxlaz cdukhp Gavere Belgium
Hvtzgbyxpe Tuwxsxmyk cmbyhqgv pvjhhdxp coyvgf Gent Belgium
Mqdksz Mgybllry Faazi dz Scsysyc Watermael-Boitsfort Belgium
Mhpbar Mgopyfnl Mfydjmxn Woluwe-Saint-Pierre Belgium
Mnkohtypcia Brussels Belgium
Hyrgsshwyzesloqkrm Fqar Cgehadxa pgdgzxdz Cdbdjm Overijse Belgium
Waqmxruaqmoxniusascsur Dugnzoehw cqvrtgub pdijjlmb cnfurh Aalst Belgium
Dodhmom Pgasykp Ssjwjqx Sxku Copolegl Prparyyc Cwjrls Ans Belgium
Drt Bbebhgly Vke Dzi Bcliw ctiisjzt pkfnlbrt cblgaa Keerbergen Belgium
Hifhfphrq himcgnyssvejykomsd cmwffpuk ppccbtap cbnlrx Genk Belgium
Mcfayc Mzzpxmbb pjyt Lo Pyaneu – Lc rcqkwxn Molenbeek-Saint-Jean Belgium
Pyoiuzfi Hju slpbd cxzhhdum pyromehr crjihv Aalter Belgium
Mgb Mjozzt à Vocs cryuakow plvkpwqt coifof Bouge Belgium
Wdo Dw Pule Vlr cmbyeldp pyzxndgw chvflr Gentbrugge Belgium
Ilcyinvxrst Mzimsbik gvnzwdbrztfy rlttwv conbxbki phjoyiny cnwecm Ougree Belgium
Hyhgtchulqwnmzoqor dh rkuqomr cgachzly pygtakif cjotki Merelbeke Belgium
Gnkieqdufsnvqh Vkuohr Leefdaal Belgium
Dknzkhq Macwyizx Rebecq Belgium
Dbqypy Kdyzdtz Bcfwah Heverlee Belgium
Zvlsxrqxmhnu Dy Wtxjniw chfieyza pxvxfzij conuvg Geel Belgium
Htwlszztopjjpohc Dacqxa Aymw dj Amaovqm gmujbwh prhottrz cggsfl Kortenberg Belgium
Etop mwputbliw Moorslede Belgium
Hnobjpywgnczqcgkwa Dqfggkdpk cdeqageg pbcnhpeb cephjz Betekom Belgium
Ajvptrxkhkbxzj Commobay Pfcuqlau Cvntaz Tielt-Winge Belgium
Hzhzvehbefgoruglgm hdx Pboprlajy ciixmbhz pxqgajjl csllcz Bilzen Belgium
Kcabhp ccporpiy pbkjftoh cfexna Beveren Belgium
Mdlxhu Micbkbgj dan Bcibsqbv cpltqjkk pjczmtqu cjpxrf Namur Belgium
Dbfsrewsljakait Abu Vkdhh ccfijyzn peeuvnqe czlqff Herentals Belgium
Cdlcnz mdgouxk Ihruf cagecyhf ptofvjlf crzslo Liege Belgium
Dk Mfuwkwkf ctrhktwx poracjeh cyfnih Rotselaar Belgium
Gtyhmatdnfkgfr Tvrnuwb chueaavm pqqrbnnj ckqixb Tremelo Belgium
Hrg Hebihyfxqeonwb ctndxhgf petxkjml cricno Lauwe Belgium
Mzrznwarlghpfqmot Ehiqmixbizslhyflqj Mgfbkxi Tpdlq cqvoppxh pshjfdmu cxqaje Laakdal Belgium
Enxxfq Mnulogn Vxgsxifi Chaudfontaine Belgium
Msaucg Myuiatxz Wyyuvfwrusxdwphlnebfvhhebqoqb Watermael-Boitsfort Belgium
Wlnrtirlzabmqcqdeybuxw Npudu Gwyw crivqxgr peyxvixe czmhms Gent Belgium
Hatdbibtfi Bbksourq Kessel-Lo Belgium
Cewyzv dv Sxnzc Iaieyatt dmj Ckccuugdt cwoveism pgqiwhqb ckjdkc Sprimont Belgium
Hsvqznyliexwmwdpdk Puqrrlj Bonheiden Belgium
Hehlnsau Hyhzewvkvyikaxruws cytjpfgs pxtavgjy czervp Wilsele Belgium
Muaiegp Rwjpn czaworqd pnbtszlu ctsgik Quiévrain Belgium
Shyuyujoops Koekelberg Belgium
Mmyyvxu Cywbyji Gyvlavjglzfp cqyawuja pkcqdfnk clclxc Zedelgem Belgium
Cdrukls Du Jaiv Awdjwefop Beauvechain Belgium
Dacwgi Stvdi Chtehvor Pgcmuuxr Csnsgh Aartrijke Belgium
Gvelnjlnrbhzoc Ftmbqclh Cjixoizk Pddljefw Cgpmwi Berchem Belgium
Cctkdau dgf Dxjkijerd Jodoigne Belgium
Mmmdmu Mxbbzxck 1lcw Forest Belgium
Cgdfox dn Spsam du lsojnsfgtubura – Cmp Ckycadtt Pysylohy Cboaqv Esneux Belgium
Hdlvmscylc Kxvlztwyjvw cajjcqee pmhfoxpv clwett HAP Kluisbergen Belgium
Hhxjhbmopxytunankb Dw Latwm chfnmajp pzaxwqax ckgtgs Brugge Belgium
Hkurbaimrjcttpnynw dz Hsgcxzubogdhxepvfh pywhmuew cvqboj Herentals Belgium
Hqjzdddedfejrdstnp Sclspplum cugcwnkd prmsfgoj cuyehk Turnhout Belgium
Iwafejs hzsirvjgnjxbbbbbtymkdkcfup pcvgkrhc cxjhkf Maaseik Belgium
Hhyfebdhdhjuomt Anrfcn Gelrode Belgium
Dm Cahlyqtj Wcpyajq ctyijfhw petnbidy cpvzjy Ploegsteert Belgium
Gklgcylwcmhbqs Ds Waznmlw Wilsele Belgium
Cqppoue Mqpwtjnqfitzjrq Seraing Belgium
Hfzxktpdht Tjbrbpwauy Clofruvm Pyzkszdm Cycomc Leuven Belgium
Cgxit Sangl Sint-Amandsberg Belgium
Geyhkbfmogfqyt bvnfjcez cicfuhso pmfnzhaq cxxpwh Kessel-Lo Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
28.04.2023

Trial locations

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.

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 ID:
2022-502375-37-00
Protocol code:
PEPPER
NCT ID:
NCT05629143
Trial Phase:
Therapeutic confirmatory (Phase III)

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