Stopping PPI Therapy in Inactive IBD (STOP-IT)

July 6, 2026 updated by: University of Nottingham

STOpping PPI Therapy in Inactive IBD Study (STOP-IT): A Feasibility Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PURPOSE

The purpose of this study is to explore the feasibility of proton pump inhibitor (PPI) withdrawal in patients with IBD in order to inform the running of a larger scale study.

PRIMARY OBJECTIVES

To understand the feasibility of PPI withdrawal in order to inform a future definitive multi-centre randomised controlled trial by investigating:

How many patients are eligible for this study. What the recruitment rate is - baseline variables predicting non-recruitment from screened patients will be investigated.

What adherence to PPI withdrawal and continuation is - non-adherence amongst recruited participants will be investigated.

What the retention of participants throughout the follow-up period of the trial is.

SECONDARY OBJECTIVES

What is the effect of PPI withdrawal on IBD disease activity?

Effect of withdrawal: For ulcerative colitis, a standardised patient-reported outcome quantifying stool frequency and rectal bleeding scores will be collected. For participants with Crohn's disease, a standardised patient-reported outcome quantifying abdominal pain and stool frequency scores will be collected. Moreover, participants will also be asked to complete the Gastrointestinal Symptom Rating Scale (GSRS) and the Glasgow Dyspepsia Severity Score (GDSS).

TRIAL DESIGN

Parallel-group, open-label randomised controlled trial recruiting participants from primary care. This is an open-label study as it is not possible to blind the clinician delivering the intervention, i.e. the withdrawal of PPI, nor the participant receiving the intervention.

Qualitative study: A semi-structured interview study will be undertaken to investigate the acceptability of and adherence to the study protocol. Interview duration will be up to one hour and will take place online via MS Teams. This may also be available to take place in person, should the participant request this instead. This will allow for further understanding of the underlying mechanisms impacting the study outcomes. This will help inform recruitment processes for downstream research proposals, improving recruitment and attrition. Interviews will follow a semi-structured interview schedule to gain greater clarification through exploration of detailed descriptions of the desired topic from participants. A sample size of approximately 20 participants was chosen. The adequacy of the final sample size will be continually assessed during the data collection process using factors of both 'data saturation' and 'information power'. Data collection and transcription will be undertaken in parallel, and NVivo 12 software will be used to aid data analysis.

RANDOMISATION AND BLINDING

The Randomisation Scheme

Participants will be randomly assigned in a 1:1 ratio to one of two study arms using a random minimisation algorithm, stratified by IBD type (50% Crohn's disease, 50% ulcerative colitis), and current use of advanced therapy (yes/no). Randomisation will be conducted through an online randomisation system, with participants allocated to one of the following groups:

Continue PPI therapy

Withdraw PPI therapy

The randomisation system will be provided by the Derby CTSU. Randomisation will be undertaken by the University of Nottingham research team using the online randomisation tool 'Sealed Envelope' hosted by Derby CTSU. Participants will be contacted by the research team at the University of Nottingham by phone or email to explain their treatment allocation. Participants will also receive a letter via DocMail to confirm their treatment allocation, and a letter (sent via electronic mail) will be sent to the GP explaining participant enrolment and treatment allocation for entry into the medical records.

This is an open-label study as it is not possible to blind the clinician delivering the intervention, i.e. the withdrawal of PPI. The data analyses will be undertaken by the research team, who will be blinded to participant allocation.

TRIAL MANAGEMENT

The trial will be managed by the study team at the University of Nottingham. There is a Trial Manager based at the University of Nottingham.

Derby CTSU will provide a web-based randomisation service and statistical services during the development, conduct, analysis and reporting stages of the feasibility trial. TCR Nottingham will be responsible for setting up the study database and data management while the team at the University of Nottingham will lead trial management, qualitative analyses and overall project delivery.

The TMG will report to the independent TSC, which will be responsible for oversight of the trial including safety oversight. Membership will include patient representation and relevant expertise. The TSC will meet (in person) prior to commencement of the trial to agree the protocol, and then at least annually (in person or by telephone conference) until completion of the trial. The TSC will be responsible for approving the trial protocol, reviewing trial progress and resolving problems brought to it by the co-ordinating centre. Reflecting the feasibility nature of this study, there will be no data monitoring committee.

The Chief Investigator has overall responsibility for the study and shall oversee all study management.

The data custodian will be the Chief Investigator.

DURATION OF THE TRIAL / STUDY AND PARTICIPANT INVOLVEMENT

Participant Duration: From the point of enrolment, participants will be invited to take part in the study for 12 months. Follow-up time points are questionnaire completion at 3, 6 and 12 months and these will be undertaken online or over the phone. Data related to outcomes 3-6 will be collected at these time points. After 3 months in the trial, participants will be invited to take part in the qualitative sub-study, which is a one-off qualitative interview study of up to one hour duration. Participants reach the end of their study participation after their month 12 follow-up is complete.

Study Duration: The planned total study duration is 24 months.

End of the Trial

Once the last 12-month follow-up is completed, the qualitative interviews for those participants who adhered to the study protocol will take place. Therefore, the end of the study is the last interview of the last fully completed participant.

SELECTION AND WITHDRAWAL OF PARTICIPANTS

Recruitment

Routinely collected data will be used to identify patients, making this data-driven trial cost-effective.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continue PPI Therapy
Drug: Continue PPI Therapy
Continue PPI therapy
Experimental: Withdraw PPI Therapy
Drug: Withdraw PPI Therapy
Withdraw PPI Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eligibility rate
Time Frame: 12 months
The proportion of screened patients meeting the study eligibility criteria.
12 months
Recruitment rate
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
The proportion of recruited participants who complete study follow-up.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of PPI withdrawal on inflammatory bowel disease activity in participants with ulcerative colitis
Time Frame: 12 months
For participants with ulcerative colitis, disease activity will be assessed using a patient-reported outcome measuring stool frequency and rectal bleeding scores.
12 months
Effect of PPI withdrawal on inflammatory bowel disease activity in participants with Crohn's disease
Time Frame: 12 months
For participants with Crohn's disease, disease activity will be assessed using a patient-reported outcome measuring abdominal pain and stool frequency scores.
12 months
Gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: 12 months
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
12 months
Dyspepsia symptoms measured using the Glasgow Dyspepsia Severity Score (GDSS)
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25053
  • 1013002 (Other Identifier: IRAS Project ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be shared with and analysed only by staff from the University of Nottingham and Derby CTSU De-identified pre-analysed data may be shared with collaborators at other UK institutions for the purposes of writing up results and dissemination. All transfers will be via encrypted file transfer.

Data generated as part of the outputs of the project (published manuscripts, published protocols) will be freely available and appropriately licensed for re-use under a CC-BY or CC-BY-NC licence.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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