Stopping PPI Therapy in Inactive IBD

NCT07691138 | Recruiting Phase 4 DMC

• 2 other identifiers: 250531013002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis (UC); Crohn's Disease

Keywords

proton pumb inhibitor; PPI; Crohn's Disease; Ulcerative Colitis; PPI Withdrawal

Outcome Measures

Primary Outcomes (4)

• Eligibility rate

  The proportion of screened patients meeting the study eligibility criteria.

  12 months

• Recruitment rate

  The proportion of eligible patients who consent to participate in the study. Baseline variables associated with non-recruitment among screened patients will also be explored.

  12 months

• Adherence to allocated intervention

  The proportion of participants adhering to their allocated treatment strategy (PPI withdrawal or PPI continuation). Factors associated with non-adherence will be explored.

  12 months

• Participant retention rate

  The proportion of recruited participants who complete study follow-up.

  12 months

Secondary Outcomes (4)

• Effect of PPI withdrawal on inflammatory bowel disease activity in participants with ulcerative colitis

  12 months

• Effect of PPI withdrawal on inflammatory bowel disease activity in participants with Crohn's disease

  12 months

• Gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS)

  12 months

• Dyspepsia symptoms measured using the Glasgow Dyspepsia Severity Score (GDSS)

  12 months

Study Arms (2)

Continue PPI Therapy

EXPERIMENTAL

Continue PPI Therapy

Drug: Continue PPI Therapy

Withdraw PPI Therapy

EXPERIMENTAL

Drug: Withdraw PPI Therapy

Interventions

Continue PPI Therapy DRUG

Continue PPI therapy

Continue PPI Therapy

Withdraw PPI Therapy DRUG

Withdraw PPI Therapy

Withdraw PPI Therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Gordon W Moran, MD, PhD

CONTACT

0115 9249924; Gordon.moran@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-group, open-label randomised controlled trial, 1:1 randomisation

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)