NCT07691138RecruitingPhase 4
Stopping PPI Therapy in Inactive IBD
STOpping PPI Therapy in Inactive IBD Study (STOP-IT): A Feasibility Study
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- University of Nottingham
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07691138
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- From 1 Jul 2026 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Illicit drug misuse
Other illness
- Peptic disease at a recent upper GI endoscopy
- Zollinger-Ellison Syndrome
- History of dementia
- Terminal illness
- Present malignancy
- Active history of mental illness
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Nottingham Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.