Stopping PPI Therapy in Inactive IBD

Sponsor
University of Nottingham
Study ID
NCT07691138
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continue PPI Therapy — DRUG
    Continue PPI therapy
  • Withdraw PPI Therapy — DRUG
    Withdraw PPI Therapy

Study Details

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 Dates

First listed
Jul 8, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Continue PPI Therapy
    Continue PPI Therapy
  • Experimental: Withdraw PPI Therapy

Primary Outcome Measure

Eligibility rate [ Time Frame: 12 months ]

Central Contacts

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