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Stopping PPI Therapy in Inactive IBD

ConditionsUlcerative Colitis (UC)Crohn's Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Nottingham

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continue PPI Therapy

    Drug

    Continue PPI therapy

  • Withdraw PPI Therapy

    Drug

    Withdraw PPI Therapy

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Continue PPI TherapyExperimental treatment 1 intervention
Group B: Withdraw PPI TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Eligibility rate

The proportion of screened patients meeting the study eligibility criteria.

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months
4

Participant retention rate

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

Time frame
12 months

Secondary outcomes

1

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

For participants with ulcerative colitis, disease activity will be assessed using a patient-reported outcome measuring stool frequency and rectal bleeding scores.

Time frame
12 months
2

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

For participants with Crohn's disease, disease activity will be assessed using a patient-reported outcome measuring abdominal pain and stool frequency scores.

Time frame
12 months
3

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

The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item patient-reported questionnaire assessing gastrointestinal symptoms across five domains: abdominal pain, reflux, indigestion, diarrhoea and constipation. Each item is scored from 1 to 7, resulting in an overall score ranging from 1 to 7, where higher scores indicate worse gastrointestinal symptoms

Time frame
12 months
4

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

The Glasgow Dyspepsia Severity Score (GDSS) is a patient-reported measure of dyspepsia severity with scores ranging from 0 to 20, where higher scores indicate more severe dyspeptic symptoms.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nottingham

Lead sponsor

Source ClinicalTrials.gov
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