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New treatment option for Ulcerative Colitis (UC)
Official title Stopping PPI Therapy in Inactive IBD
ClinicalTrials.gov ID: NCT07691138
What this study is testing
What is Continue PPI Therapy?
Continue PPI Therapy is an investigational medicine, being studied as a potential treatment for ulcerative colitis (uc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.