Stop PPI in active IBD: can you safely go without acid-suppressing meds?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4, open-label, parallel-group randomized trial conducted at a single center. It compares continuing PPI therapy versus withdrawing PPI therapy in adults with ulcerative colitis or Crohn's disease who have been on PPIs for more than six months. The trial aims to assess feasibility metrics such as the proportion eligible, recruitment rate, adherence, and retention, while also collecting disease activity and symptom scores through patient-reported outcomes and standardized measures. Results will inform the design of a future multi-center randomized controlled trial on the safety and impact of PPI withdrawal in IBD.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Nottingham
  Nottingham, United Kingdom Recruiting

Study contacts

• Study coordinator: Gordon W Moran, MD, PhD
• Email: Gordon.moran@nottingham.ac.uk
• Phone: 0115 9249924

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.