RecruitingPHASE4INTERVENTIONAL

Stopping PPI Therapy in Inactive IBD

This study, for people with inactive Ulcerative Colitis or Crohn's Disease, is about safely stopping a type of stomach medicine called PPIs. We want to see if it's possible for people to stop taking these medicines, how many would want to, and if it affects their gut health. Some research suggests that people with gut conditions who take PPIs might have more health problems. This small study, done in GP practices, will help us plan a larger study in the future. We'll follow participants for a year to see what happens when they stop taking PPIs compared to those who continue, and if it impacts their gut condition.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University of Nottingham

Enrolment target

Start

01 Jul 2026

Estimated completion

01 Jul 2027

Ulcerative Colitis (UC)Crohn's Disease

What is this study about?

This study is looking into a common type of medicine called proton pump inhibitors, or PPIs, which are often used to reduce stomach acid. Some people with gut conditions like Ulcerative Colitis or Crohn's Disease take these medicines. We've noticed that people with these conditions who take PPIs sometimes have more health issues than those who don't, and this might be due to changes in the helpful bacteria in their gut.

Because of this, we want to find out if it's safe and possible for people with inactive Ulcerative Colitis or Crohn's Disease to stop taking their PPIs. Before we can do a big study to answer this question fully, we need to understand a few things. For example, how many people with these gut conditions actually take PPIs, how many would be able to stop without problems, and how many would be willing to take part in such a study. We also need to understand if stopping PPIs might temporarily increase acid reflux symptoms.

This small study will help us gather important information to plan a much larger, more detailed study in the future. We will invite people to take part through their local GP practice, which is a new way for us to do research for these conditions. We'll follow people for a year to see if stopping PPIs changes their gut condition. Half of the participants will stop taking their PPIs, and the other half will continue, allowing us to compare the two groups.

Key takeaways

The study looks at common stomach medicines (PPIs) and IBD.
It aims to see if people with inactive IBD can safely stop PPIs.
Half of participants will stop PPIs, half will continue.
Participants will be followed for 12 months.
The study helps plan future, bigger research into PPIs and IBD.
It's being run through GP practices.

Who may be eligible?

To join this study, you need to be at least 16 years old and have a diagnosis of Ulcerative Colitis or Crohn's Disease. You also need to have been taking a PPI medicine regularly for at least six months and usually take your medicine as prescribed.

There are some reasons why you might not be able to join. For example, if you have certain other serious health problems like Barrett's oesophagus, specific stomach conditions (like recent ulcers), or other long-term illnesses. You also can't join if you take certain pain medications called NSAIDs regularly, or if you've recently had changes to your IBD medicine or surgery in the last three months.

We also need to make sure you can fully take part in the study and understand what's involved. If you have conditions like dementia, issues with alcohol or drug misuse, or are in a care home, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years old or older?
Do you have Ulcerative Colitis or Crohn's Disease?
Have you been taking a PPI medicine regularly for at least 6 months?
Has your IBD been stable without recent medication changes or surgery (last 3 months)?
Do you feel you can fully understand and take part in the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of 80 people taking part. Half of the participants will be asked to gradually stop taking their PPI medicine, while the other half will continue taking it as usual. We'll follow your progress for 12 months. During this time, we'll ask you to answer questions about your health and how you're feeling, especially regarding your gut condition and any stomach symptoms. For people with Ulcerative Colitis, we'll be looking at things like stool frequency and any bleeding. For those with Crohn's Disease, it will be about abdominal pain and stool frequency. Some participants may also be invited to have an online chat with us for up to an hour to talk about their experience.

Potential risks and benefits

Taking part in this study could help us learn valuable information about treating Ulcerative Colitis and Crohn's Disease in the future, which could benefit many patients. You might experience a temporary increase in acid reflux symptoms if you stop your PPI. However, we'll be carefully monitoring everyone involved. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Nottingham
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What are PPIs?

PPIs (Proton Pump Inhibitors) are common medicines used to reduce the amount of acid in your stomach, often prescribed for conditions like heartburn or indigestion.

What is inactive IBD?

Inactive IBD means your Ulcerative Colitis or Crohn's Disease is currently stable, and you haven't had recent changes in your medication or surgery for it.

Why are you doing this study?

We want to see if safely stopping PPIs in people with IBD is possible and if it affects their gut health, as some research suggests PPIs might not be ideal for everyone with IBD long-term.

Will I have to stop my PPI if I join?

Not necessarily. Half of the participants will gradually stop their PPI medicine, and the other half will continue taking it as they do now.

How long will the study last for me?

If you join the study, we will follow your health and progress for 12 months (one year).

How to find out more

Gordon W Moran, MD, PhD

gordon.moran@nottingham.ac.uk 0115 9249924 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.