Guiding the safe reduction of unnecessary proton pump inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DROPIT Trial is an interventional, open-labelled, cluster-randomized controlled trial conducted in Swiss primary care settings. It aims to evaluate an intervention designed to guide the deprescribing of inappropriate proton pump inhibitors (PPIs) while ensuring patient safety. The trial will assess the effectiveness of this intervention compared to usual care, focusing on the deprescribing process, clinical outcomes, and cost-effectiveness. Additionally, the study will provide necessary tools and training for general practitioners and patients to facilitate safe deprescribing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient of a participating GP.
2. Age: minimum 18 years old.
3. Daily PPI intake for minimum 8 weeks.
4. PPI in one of the following doses:

   * minimum 40mg/day pantoprazole;
   * minimum 40mg/day omeprazole;
   * more than 30mg/day lansoprazole;
   * more than 30mg/day dexlansoprazole;
   * more than 20mg/day esomeprazole;
   * more than 20mg/day rabeprazole.
5. Sufficient knowledge of German language to understand the trial and follow-up according to GP assessment.

Exclusion Criteria:

1. Limited life expectancy according to GP judgement (patients with terminal disease and a life expectancy of less than 12 months.
2. Unable to provide informed consent.
3. PPI in an appropriate dose (see Appendix Table A1) and with an established indication for long-term PPI, such as:

   * History of bleeding ulcer.
   * Peptic ulcer due to cause other than NSAID or H. Pylori.
   * Barrett's oesophagus.
   * Severe erosive reflux disease (Los Angeles grade C/D).
   * GERD with symptoms or complications (oesophageal ulcer, peptic stricture).
   * Other indications (i.e., Zollinger-Ellison-Syndrome, PPI-sensitive eosinophilic esophagitis, chronic pancreatitis with steatorrhea refractory to enzyme replacement therapy, idiopathic pulmonary fibrosis.)
4. Two or more of the following medications, or one of the following medications and one or more of the mentioned risk factors mentioned below.

Medications (any dose):

* Daily use of non-steroidal anti-inflammatory drug (NSAID) for more than 7 days.
* Antiplatelet therapy.
* Additional antiplatelet therapy (e.g., ticagrelor or similar).
* Anticoagulant(s).
* Systemic steroid(s) for more than 1 month.

Risk factors:

* History of gastrointestinal ulcer.
* Age of 75 years and older.
* Selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) use.
* Severe concomitant disease with increased risk of GI bleeding according to the GP's assessment (e.g., severe liver disease, neoplasia, nicotine or alcohol abuse).

Where it's running

• University of Bern
  Bern, Switzerland Recruiting
• Prof. Dr. med. Dr. phil. Sven Streit
  Bern, Switzerland Not yet recruiting

Study contacts

• Principal investigator: Sven Streit, Prof. Dr. med. Dr. phil — University of Bern, Institute of Primary Health Care (BIHAM)
• Study coordinator: Sven Streit, Prof. Dr med. Dr. phil.
• Email: sven.streit@unibe.ch
• Phone: +41 31 684 58 75

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Probiotic support for GERD patients on PPI therapy

  A small, two-arm study tests a probiotic supplement versus placebo to see if it changes gut and oral microbes and improves GERD symptoms and quality of life for people on PPI therapy.

  Recruiting Early Phase 1 University Hospital Olomouc · Olomouc · NCT07600008

• Improving the use of proton pump inhibitors through pharmacist education

  This study tests if teaching pharmacists how to better educate patients and doctors can help reduce unnecessary use of proton pump inhibitors in adults.

  Recruiting RAK Medical and Health Sciences University · Ras al-Khaimah · NCT06858384

• Comparing Vonoprazan and oral PPIs for bleeding peptic ulcers

  This study tests whether a new medication called Vonoprazan is as good as standard proton pump inhibitors in preventing bleeding from peptic ulcers after treatment.

  Recruiting Phase 4 Chinese University of Hong Kong · Guangzhou, Guangdong and 7 other locations · NCT05582174

• Predictors of symptom improvement after laparoscopic fundoplication

  This study tests what preoperative factors help predict which GERD patients will feel better after laparoscopic fundoplication.

  Recruiting Minia University · Minya, Minya Governorate · NCT07809620

• Thread-Embedding Acupuncture plus a Proton Pump Inhibitor for GERD

  This study tests whether adding thread-embedding acupuncture to standard omeprazole treatment helps people with GERD who have a traditional Liver-Stomach constraint-heat pattern.

  Recruiting University of Science Ho Chi Minh City · Ho Chi Minh City · NCT07797959

• Managing GERD with personalized dietary changes and guided education

  A dietary plan and written education are being tested to see if they help adults with chronic GERD reduce symptoms.

  Recruiting Hualien Tzu Chi General Hospital · Hualien City, Taiwan · NCT07754721

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.