Not yet recruitingNAINTERVENTIONAL

MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO)

Many adults with Cystic Fibrosis (CF) experience uncomfortable gut problems like bloating, gas, and constipation because the gut produces thick mucus. Current treatments aren't always ideal. This study aims to find better ways to help and understand how the CF gut works. Researchers will use a special type of MRI scan, which is painless and doesn't use radiation, to look at how fluid moves through the gut in adults with CF. Participants will take either a study medication called linaclotide or a dummy pill (placebo). Linaclotide is already used for chronic constipation and helps the gut release more fluid to ease movement. The study will see if these MRI scans can reliably show how linaclotide affects gut fluid and movement, paving the way for larger future studies.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Nottingham

Enrolment target

Start

01 Sep 2026

Estimated completion

01 Aug 2027

Cystic Fibrosis (CF)

What is this study about?

Cystic Fibrosis (CF) is a condition passed down through families that affects several parts of the body, including the digestive system. Many people with CF often feel uncomfortable because of problems like bloating, tummy pain, and constipation. This happens because the gut makes mucus that's thicker than usual, which slows everything down and makes it harder for food to move through properly.

Currently available treatments, such as laxatives or enemas, can be inconvenient and don't always fully solve the problem. Because of this, there's a real need to find better ways to help people manage their gut symptoms and to better understand exactly what's happening inside the gut of someone with CF and how it responds to different treatments.

This study, called FEMPTO, is using a special type of scan called an MRI (Magnetic Resonance Imaging). MRI scans are safe and don't involve radiation; they use strong magnets and radio waves to create detailed pictures inside your body. The researchers want to see how a medication called linaclotide affects how fluid moves through the gut. Linaclotide is a medicine already approved for treating long-term constipation and irritable bowel syndrome. It works by encouraging the gut to release more fluid, which helps everything move along more easily. It works directly in the gut and isn't absorbed into the bloodstream. Early studies suggest it might help in CF, not by fixing the underlying genetic problem, but by improving how the gut works day-to-day. The main goal of this study is to check if these MRI measurements are a good way to see changes in the gut and to help plan bigger studies in the future.

Key takeaways

Investigates new ways to help gut problems in adults with Cystic Fibrosis.
Uses safe MRI scans to look at how a medication affects fluid in the gut.
Linaclotide is a medication that helps the gut move more easily by increasing fluid.
This is a small, 'pilot' study to test if the MRI methods are effective for future research.
Participation involves MRI scans, taking medication, and tracking bowel habits for a few days.
Helps understand CF gut function for future improved treatments.

Who may be eligible?

This study is looking for adults aged between 18 and 50 years old who have a confirmed diagnosis of Cystic Fibrosis. You should be generally well enough to take part and be able to follow the study instructions, including diet changes, taking the study medication, and having MRI scans.

There are certain reasons why you might not be able to join. For example, if you are pregnant, planning to become pregnant, or breastfeeding. Also, if you have had surgery on your gut (apart from your appendix), have other serious digestive problems not related to CF, or if you can't have MRI scans due to certain metal implants in your body.

You should not be taking regular pain relief like ibuprofen or paracetamol (though some other medicines like CF treatments, some antidepressants, allergy medicines, and the contraceptive pill are usually fine). You also can't have taken a course of strong antibiotics in the last two weeks or have ongoing severe diarrhoea.

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.

Do I have a confirmed diagnosis of Cystic Fibrosis?
Am I aged between 18 and 50 years old?
Am I NOT pregnant, planning to be pregnant, or breastfeeding?
Can I have an MRI scan (e.g., no problematic metal implants)?
Have I avoided strong antibiotics in the last two weeks?
Do I generally feel well and can follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first need to give your informed consent, which means you understand what's involved and agree to participate. You will be randomly chosen to receive either linaclotide or a dummy pill (placebo) for the study. You will take this medication the day before and on the day of your MRI scans.

On the main study day, you will undergo several MRI scans over about 6 hours. During this time, you will also eat a standard rice pudding meal, and then a second meal later on. You'll need to follow specific dietary and lifestyle instructions, including fasting overnight before the study day. For a few days after the study, you'll be asked to keep a record of your bowel habits, such as how often you go to the toilet and the consistency of your stools.

This is a pilot study, meaning it’s a smaller trial to test the methods. The total time you'd be actively involved in the study assessments would be concentrated around the MRI scan day and the few days recording your bowel habits. The research team will explain all the details thoroughly before you decide to join.

Potential risks and benefits

By taking part in this study, you could help researchers better understand how gut problems affect people with CF and how new treatments might work. This could lead to improved care for others in the future. It’s important to know that you might not personally benefit from taking part, as this is a pilot study and you might receive a placebo. The main risks are generally low, as MRI scans are safe and linaclotide is an approved medication, though like all medicines, it can have side effects. You might experience some temporary discomfort from the study procedures, such as having to fast or spend several hours in the MRI scanner. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Sir Peter Mansfield Imaging Centre
Verified postcode
Nottingham, United Kingdom

Common questions

What is an MRI scan and is it safe?

An MRI scan uses magnets and radio waves to take pictures inside your body. It is generally very safe and doesn't use X-rays or radiation.

What is linaclotide and how does it work?

Linaclotide is a medicine that helps your gut release more fluid, making it easier for food and waste to move through, which can relieve constipation.

Will I definitely get the active medication?

No, this is a 'randomised' study, meaning you will be randomly assigned to receive either the active medication (linaclotide) or a dummy pill (placebo).

Why do I have to eat specific meals during the study?

Eating standard meals helps researchers understand how your gut processes food and fluid in a consistent way, which is important for comparing results between participants.

What is the main goal of this study?

The main goal is to see if special MRI measurements can accurately show changes in gut fluid and movement, to help plan bigger future studies on new treatments for CF.

How to find out more

Abi Spicer, PhD

ms-fempto@nottingham.ac.uk +44-7855 193162 Official trial record

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