Ulcerative Colitis (UC)Phase 4STOP-ITNCT07691138
Stopping PPI Therapy in Inactive IBD
A Phase 4 study testing Continue PPI Therapy and Withdraw PPI Therapy in people with Ulcerative Colitis (UC) and Crohn's Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ulcerative Colitis (UC), Crohn's Disease
- What is being tested?
- Continue PPI Therapy and Withdraw PPI Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2026to 1 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham
Nottingham
Gordon W Moran, MD, PhD, 0115 9249924 ext. 80608, Gordon.moran@nottingham.ac.uk
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Ulcerative Colitis (UC), Crohn's Disease
- Being tested
- Continue PPI Therapy, Withdraw PPI Therapy
- Keywords
- proton pumb inhibitor, PPI, Crohn's Disease, Ulcerative Colitis, PPI Withdrawal
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continue PPI TherapyDrug
Continue PPI therapy
Withdraw PPI TherapyDrug
Withdraw PPI Therapy
| Study group | Role | What they receive |
|---|---|---|
| Continue PPI Therapy | Experimental | Continue PPI Therapy Receives: Drug: Continue PPI Therapy |
| Withdraw PPI Therapy | Experimental | Not described Receives: Drug: Withdraw PPI Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility rate
The proportion of screened patients meeting the study eligibility criteria.
Measured: 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.
Measured: 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.
Measured: 12 months
Participant retention rate
The proportion of recruited participants who complete study follow-up.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
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.
Measured: 12 months
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
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group, open-label randomised controlled trial, 1:1 randomisation
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691138
- Sponsor's protocol ID
- 25053
- Other IDs
- 1013002
- Acronym
- STOP-IT
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOpping PPI Therapy in Inactive IBD Study (STOP-IT): A Feasibility Study
- ClinicalTrials.gov ID
- NCT07691138
- Acronym / sponsor ID
- STOP-IT / 25053
- Conditions
- Ulcerative Colitis (UC), Crohn's Disease
- Keywords
- proton pumb inhibitor, PPI, Crohn's Disease, Ulcerative Colitis, PPI Withdrawal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group, open-label randomised controlled trial, 1:1 randomisation
| Arm | Type | Receives |
|---|---|---|
| Continue PPI Therapy | Experimental | Drug: Continue PPI TherapyContinue PPI Therapy |
| Withdraw PPI Therapy | Experimental | Drug: Withdraw PPI Therapy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continue PPI TherapyContinue PPI therapy | Drug | Continue PPI Therapy |
| Withdraw PPI TherapyWithdraw PPI Therapy | Drug | Withdraw PPI Therapy |
Primary outcome
Eligibility rate
Time frame: 12 months
The proportion of screened patients meeting the study eligibility criteria.
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.
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.
Participant retention rate
Time frame: 12 months
The proportion of recruited participants who complete study follow-up.
4 secondary outcomes
Effect of PPI withdrawal on inflammatory bowel disease activity in participants with ulcerative colitis
Time frame: 12 months
Effect of PPI withdrawal on inflammatory bowel disease activity in participants with Crohn's disease
Time frame: 12 months
Gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 12 months
Dyspepsia symptoms measured using the Glasgow Dyspepsia Severity Score (GDSS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continue PPI Therapy and Withdraw PPI Therapy in people with Ulcerative Colitis (UC) and Crohn's Disease, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gordon W Moran, MD, PhD (0115 9249924 ext. 80608, Gordon.moran@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility rate (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.