Around 14% of people with inflammatory bowel disease are taking acid-suppressing drugs called proton pump inhibitors, often long after the original reason for the prescription has passed. These drugs may worsen IBD by removing the stomach’s acid barrier, allowing bacteria to migrate into the gut and fuel inflammation. This study tests whether it is feasible to safely withdraw PPIs from IBD patients who no longer need them. The researchers will recruit patients through GP practices, using routine health data to identify candidates, and will monitor whether stopping the drugs affects disease activity. If PPI withdrawal proves feasible and reduces flare-ups, the intervention is simple and low-cost—requiring no new drugs or equipment. For the NHS, fewer severe relapses would mean fewer hospital admissions and substantial savings on both PPI prescriptions and emergency care. The study also includes interviews with patients to understand what helps or hinders adherence to stopping the medication, ensuring any future trial is designed around real-world barriers.
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Research question: What is the feasibility of conducting a trial to investigate the efficacy of PPI withdrawal for adults with IBD? Background: UK Inflammatory Bowel Disease (IBD) prevalence is 0.8%(1). Improving disease outcomes is a research priority set out by the James Lind Alliance Priority-Setting Partnership(2). 14% of IBD patients are co-prescribed Proton Pump Inhibitors (PPI)(3-5), most commonly due to historic symptoms of heartburn and during co-prescription with short courses of corticosteroids. Thereafter, PPI prescribing is not routinely audited in primary or secondary care and such prescriptions continue long term without a strong clinical indication. PPI use abolishes the gastric acid barrier which may increase bacterial migration to the intestinal lumen and (6) enhance chronic inflammation(7), which may worsen disease outcomes. Observational data suggests that a) a considerable proportion of PPI users do not need these medication(8, 9) and b) PPI use may worsen IBD outcomes (3, 10-12). Aims and Objectives: We aim to conduct this feasibility trial in primary care. The main aim of the trial is to investigate the feasibility of PPI withdrawal in IBD in order to inform a future definitive multi-centre randomised controlled trial. The main uncertainties to be addressed are: How many patients are eligible for this study. What is the recruitment rate per 10,000 patient population? What is the adherence to PPI withdrawal and continuation? What is the effect of PPI withdrawal on IBD disease activity? Methods: We will conduct an initial Delphi exercise inviting 30 expert participants to refine the intervention for use in the feasibility study. We will then conduct a parallel-group, open-label, RCT. We will recruit 80 IBD patients registered with up to 150 primary care general practices. We will use routinely collected data to identify patients, making this a cost-effective data driven trial. A bespoke trial web-based toolkit, secure trial database and software management system will be developed. Outcome data sets related to adherence and effect of PPI withdrawal on disease activity will be collected remotely or in person participant contact through clinical research forms with data collection every 3 months with a last follow-up at 12 months. There will be a nested qualitative interview, recruiting 20 participants from those already enrolled in the trial, study to explore factors impacting on PPI withdrawal adherence. Timelines for delivery: We plan to undertake this research over 36 months. Anticipated Impact and Dissemination: The proposed simple low-cost intervention is PPI withdrawal in IBD to reduce disease activity, and therefore hospitalisations. Based on assumptions regarding standard NHS based costs, the cost of a severe IBD relapse to be ~£10,000(13), this intervention could lead to a cost-saving > £50,000,000 over 5 years for the NHS apart from the cost saving of PPI withdrawal itself. Dissemination will be co-managed with a patient advisory group to ensure our findings are accessible to all patients. Findings will be disseminated via research papers for publication in peer reviewed journals, presentation at medical conferences and communication through patient symposia (Crohn s and Colitis UK and INVOLVE).
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