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Stopping PPI Therapy in Inactive IBD

RecruitingPhase 4Ages 16 Years - anyAllUniversity of Nottingham
NCT07691138 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

To investigate the feasibility of proton pump inhibitor (PPI) withdrawal in inflammatory bowel disease (IBD); the data collected will provide valuable information to inform a future multi-centre randomised controlled trial. Evidence suggests that patients with IBD taking PPIs respond less well to medication and require hospital treatment more frequently than patients not taking PPIs. This may be due to changes in the gut microbiota associated with PPI use. A future definitive trial is planned to investigate clinical outcomes in patients who stop PPIs compared with those who continue PPIs, in order to determine the safety implications of PPI use in IBD. However, several uncertainties remain which require investigation before such a trial can be undertaken. It is currently unknown how many patients with IBD take PPIs, how many can successfully stop taking PPIs, how many would be willing

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 16 years or older. * An IBD diagnosis as defined through SNOMED codes in primary care databases \[Appendix 5\] * Taking a PPI regularly for \>6 months prior to enrolment * Patient-confirmed compliance with PPI therapy (\>75% of prescribed doses) * Able to give full, independent valid Informed consent * Stable disease as defined by no change in medication or IBD-related surgery for the last 3 months. Exclusion Criteria: * Unable to participate fully in all aspects of the clinical trial. * Barrett's oesophagus * Peptic disease at a recent upper GI endoscopy * Zollinger-Ellison Syndrome * Eosinophilic oesophagitis * Chronic NSAID usage * Pulmonary fibrosis. * Declined consent to data sharing * History of dementia * Terminal illness * Present malignancy * Active history of mental illness * In a care home * Alcohol misuse * Illicit drug misuse
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What it tests

  • Continue PPI Therapy
  • Withdraw PPI Therapy
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Where

1 site
University of Nottingham
Nottingham, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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