NCT07691138 Stopping PPI Therapy in Inactive IBD
| NCT ID | NCT07691138 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Nottingham |
| Condition | Ulcerative Colitis (UC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2026-07-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07691138 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Ulcerative Colitis (UC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07691138 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07691138 currently recruiting?
Yes, NCT07691138 is actively recruiting participants. Contact the research team at Gordon.moran@nottingham.ac.uk for enrollment information.
Where is the NCT07691138 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom.
Who is sponsoring the NCT07691138 clinical trial?
NCT07691138 is sponsored by University of Nottingham. The trial plans to enroll 80 participants.
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