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Taking people in United KingdomPhase 4

Stopping Acid-Reducing Pills in People With Inactive Inflammatory Bowel Disease

Tests whether people with ulcerative colitis or Crohn's disease can stop PPI medicines.

Plain-language title generated from the registry record
Registry title: Stopping PPI Therapy in Inactive IBD

Key facts

Where
Nottingham, United KingdomSee the site
Phase
Phase 4

Where in United Kingdom

  • University of NottinghamNottingham, United KingdomTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Nottingham
Trial code
NCT07691138
Record updated
8 July 2026
Original description
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.Read full original descriptionShow less

STOpping PPI Therapy in Inactive IBD Study (STOP-IT): A Feasibility Study

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 to stop treatment, and how many would remain off treatment long term. In some cases, withdrawal of PPIs may result in a short-term increase in acid reflux symptoms. The willingness of patients to participate in such a study is also unknown. This study will be conducted in GP practices, a setting in which IBD trials have not previously been undertaken.

The study will recruit 80 participants with IBD aged 16 years and over who have been taking PPIs regularly for more than six months. Half of participants will be randomised to discontinue PPI therapy. Participants will be followed up for 12 months. The study will provide information regarding recruitment rates within GP practices, optimal methods for PPI withdrawal, and whether stopping PPIs affects IBD outcomes.

Inclusion: 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: Illicit drug misuse; Peptic disease at a recent upper GI endoscopy; Zollinger-Ellison Syndrome; History of dementia; Terminal illness; Present malignancy; Active history of mental illness; Unable to participate fully in all aspects of the clinical trial; Barrett's oesophagus; Eosinophilic oesophagitis; Chronic NSAID usage; Pulmonary fibrosis; Declined consent to data sharing; In a care home; Alcohol misuse.

ClinicalTrials.gov NCT07691138