Stopping PPI Therapy in Inactive IBD

Recruiting now · Phase 4

Conditions studied: Ulcerative Colitis (UC), Crohn's Disease

In brief

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.

Key facts

Study ID

NCT07691138

Run by

University of Nottingham

People needed

80

Starts

2026-07-01

Expected to finish

2027-07-01

Last updated by the study team

2026-07-08

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Nottingham — Nottingham, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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