RecruitingOBSERVATIONAL

DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis

The DELIVER study is exploring a new, simple breath test to detect liver scarring, also known as cirrhosis, at an earlier stage. Many people don't know they have cirrhosis until it's quite advanced, making treatments less effective. This research aims to change that. We know that when your liver isn't working as it should, it changes how your body deals with certain substances. This study involves participants drinking a special liquid containing common food additives. Researchers then measure the tiny amounts of these substances that your body breathes out. By comparing people with suspected cirrhosis to those without, the study hopes to create a reliable breath test to help doctors find liver problems sooner, allowing for more effective treatment.

At a glance

Status

Recruiting

Sponsor

Owlstone Ltd

Enrolment target

240

Start

10 May 2024

Estimated completion

01 Dec 2025

Cirrhosis, Liver

What is this study about?

The DELIVER study is looking for new and simpler ways to detect liver scarring, a condition called cirrhosis. Currently, many people don't find out they have cirrhosis until it's quite advanced, sometimes when they end up in A&E. At this late stage, treatments are often less effective, and the disease has progressed significantly. This study aims to help change that by finding a way to spot cirrhosis earlier.

At the moment, finding cirrhosis early can be difficult because you might not have many symptoms, or any at all. The tests that are available can sometimes be uncomfortable or not very accurate. The DELIVER study is researching whether a new breath test could be an easy and non-invasive way to check for liver scarring, helping doctors diagnose it sooner when treatments have a better chance of working well to protect your liver health.

Here's how the breath test idea works: Our bodies naturally produce certain substances that we breathe out. When someone has a health condition like cirrhosis, the way their body processes things can change, and this might alter the substances in their breath. This study focuses on giving participants a special drink containing common food additives. These additives are processed by your liver. If your liver isn't working as it should (because of cirrhosis), it might process these additives differently, leading to different substances being breathed out. Researchers will then collect breath samples to see if these differences can help them develop an accurate test to identify cirrhosis.

Key takeaways

This study aims to develop a new, easier breath test for liver scarring (cirrhosis).
It involves drinking a special liquid and breathing into a machine.
Early detection of cirrhosis is crucial for more effective treatment.
The study hopes to create a test suitable for wider use, including in local GP clinics.
Participation could help improve future diagnosis for others.

Who may be eligible?

The study is looking for adults aged 18 or over who have been told by their doctor in the last six months that they suspect they might have liver scarring (cirrhosis). Your doctor's suspicion could be based on a combination of things, like certain risk factors (such as viral hepatitis or a history of heavy drinking), or symptoms you might be experiencing (like tiredness, tummy pain, or changes in certain blood tests).

However, some people won't be able to join the study. This includes women who are pregnant or breastfeeding, or if you've recently had treatment for your liver condition that aimed to change its course. Also, if you're on kidney dialysis, have certain other serious health conditions like liver cancer, or have known allergies to ingredients in the special drink, you won't be eligible. The researchers also need to make sure you can comfortably take part in the breath test, so if that's not possible, you might not be able to join.

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 18 years old or older?
Has a doctor told you in the last six months that they suspect you might have liver scarring?
Are you able to agree in writing to take part in the study?
Are you not pregnant, breastfeeding, or planning to become pregnant?
Do you have any known allergies to common food additives like natural flavourings (limonene), artificial sweeteners (sucralose), or an ingredient called polysorbate 80 (Tween-80)?
Have you had any treatment in the last six months specifically to change the course of your liver condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to drink a special liquid (called Libra Oral Solution). Afterwards, you'll need to breathe into a machine so researchers can collect samples of your breath. This process helps them see how your body has processed the liquid. The study is designed to compare people with suspected liver scarring against those without, helping to develop a new test. We're not given details about the number of visits, how long each visit will be, how often you'll need to attend, or the total duration of your participation in this summary.

Potential risks and benefits

Taking part in this study could help scientists develop a new, non-invasive breath test that could one day lead to earlier and easier diagnosis of liver scarring (cirrhosis) for many people. The main risk associated with the study is a potential allergic reaction to the special drink, as it contains common food additives like certain flavourings and thickeners. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Arizona Liver Health
Verified postcode
Chandler, United States· Recruiting
Hospital Padre Hurtrado
Verified postcode
Santiago, Chile· Recruiting
Norfolk and Norwich Hospital
Verified postcode
Norwich, United Kingdom· Recruiting
Peterborough City Hospital
Verified postcode
Peterborough, United Kingdom· Recruiting

Common questions

What is cirrhosis?

Cirrhosis is a serious condition where your liver becomes badly scarred, stopping it from working properly. It can have many different causes.

What is a 'breath test'?

A breath test is a simple way to check your health by analysing substances you breathe out. In this study, it involves drinking a liquid and then breathing into a machine.

Is the special drink safe?

The special drink contains common food additives. However, if you have known allergies to certain ingredients like limonene or sucralose, then this study may not be suitable for you.

Why is early diagnosis important for liver disease?

Finding liver scarring early means treatments are often more effective at protecting your liver and improving your long-term health.

Will this test immediately diagnose my cirrhosis?

No, this study is about developing and testing a new diagnostic method. The results will help the researchers refine the test, but it's not a diagnostic test for immediate use.

How to find out more

Chloe Ms Bartlett

chloe.bartlett@owlstone.co.uk + 44 07821 655984 Official trial record

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