Stopping PPI Therapy in Inactive IBD
Phase 4 · Testing Continue PPI Therapy and Withdraw PPI Therapy · 1 site · University of Nottingham
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Continue PPI Therapy (a drug) and Withdraw PPI Therapy (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC) and Crohn's Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 16 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 3 more requirement(s). There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2026-07-01 (planned).
- Main results expected around 2027-07-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Main thing being measured
- Eligibility rate (12 months)
In the researchers’ words
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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); Crohn's Disease |
| Lead sponsor | University of Nottingham |
| Enrollment | 80 (estimated) |
| Start date | 2026-07-01 |
| Primary completion (est.) | 2027-07-01 |
| First posted | 2026-07-08 |
| Last updated | 2026-07-08 |
| Official title | STOpping PPI Therapy in Inactive IBD Study (STOP-IT): A Feasibility Study |
| ClinicalTrials.gov ID | NCT07691138 |
Interventions
- Continue PPI Therapy (Drug)
Continue PPI therapy - Withdraw PPI Therapy (Drug)
Withdraw PPI Therapy
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Nottingham | Nottingham | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.