Not yet recruitingNAINTERVENTIONAL

Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD

This research investigates a common liver condition called MASLD, which affects many adults, especially those with obesity or type 2 diabetes. We are particularly interested in how the bacteria living in our gut (the 'gut microbiota') produce certain chemicals. Previous research suggests these chemicals might play a role in making MASLD worse, particularly in how much fat builds up in the liver and how much scarring occurs. By understanding how these gut-produced chemicals affect the liver, we hope to find new ways to treat MASLD. To do this, we will collect samples of stool, blood, and urine, and look at diets of people with MASLD and healthy volunteers.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

01 May 2026

Estimated completion

01 Nov 2026

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Metabolic Dysfunction-Associated Steatohepatitis (MASH)

What is this study about?

This study is about a very common liver condition called MASLD, which stands for Metabolic Dysfunction-Associated Steatotic Liver Disease. Lots of people have MASLD, especially if they are overweight or have type 2 diabetes. It means there's too much fat in the liver. Sometimes, this can get worse and lead to another condition called MASH, where the liver not only has fat but also becomes inflamed and can get damaged over time.

We know that the 'gut bacteria' – the tiny living organisms in our intestines – play a big role in our overall health, including the health of our liver. This connection is sometimes called the 'gut-liver axis'. Scientists have found that the types of bacteria in the gut can be different in people with MASLD. These gut bacteria can produce various chemicals from the food we eat. We are particularly interested in certain chemicals made from building blocks called amino acids (like tryptophan and phenylalanine).

Previous studies have shown that some of these specific chemicals, such as NAPA, PAA, HPL, and PL, might be linked to how severe MASLD is, especially how much fat is in the liver. We believe that if we can understand exactly which gut bacteria produce these chemicals and how they affect the liver, we might be able to develop new treatments for MASLD. This study aims to explore this idea by looking at samples from people with MASLD.

Key takeaways

MASLD is a common liver condition often linked to being overweight or having type 2 diabetes.
The study explores how gut bacteria produce chemicals that might affect MASLD.
Researchers will collect stool, blood, and urine samples, and assess diet.
The findings could lead to new treatments for MASLD in the future.
Participation contributes to scientific understanding, not a direct treatment for you.

Who may be eligible?

To take part in this study, you would need to be between 18 and 80 years old. If you're a woman who could become pregnant, you'd need to be using reliable contraception. You must be in good overall health, without serious ongoing illnesses, and have regular bowel movements every 24 to 48 hours. You also can't have had certain operations like removing part of your bowel or gallbladder, and you shouldn't have used antibiotics, prebiotics, or probiotics in the last three months.

If you have MASLD, you'd need to have been diagnosed through a scan that showed fat in your liver within the past year. You also need to have at least one other health factor like high cholesterol, high blood pressure, being overweight, or having issues with blood sugar. Importantly, you shouldn't drink excessive alcohol and must be cared for by the Endocrinology, Diabetes and Nutrition Department at Lyon Sud Hospital. We're specifically looking for people who are not diabetic or whose diabetes is well-managed without insulin or other strong medication, and who haven't had a liver transplant.

People who cannot take part include those who are pregnant or breastfeeding, people with chronic constipation, or those who use laxatives frequently. We also can't include anyone with active inflammatory conditions, infections, heart problems, or cancer. The study is for people living within 100 km of the Lyon Sud Hospital Center who are willing to give written agreement 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 between 18 and 80 years old?
Do you have a diagnosis of MASLD confirmed by a scan within the last year?
Do you have regular bowel movements (every 24-48 hours)?
Have you *not* taken antibiotics, prebiotics, or probiotics in the last 3 months?
Do you live within 100 km of the Lyon Sud Hospital Center and are you cared for by their Endocrinology, Diabetes and Nutrition Department?
Are you *not* pregnant, breastfeeding, or suffering from chronic constipation or other serious ongoing illnesses?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to provide several samples. This will include stool samples, which help us look at your gut bacteria, as well as blood and urine samples to check for specific chemicals. We will also ask you about your diet to understand what foods you typically eat.

We will use two main approaches in the study. One involves growing and studying your gut bacteria in a laboratory. The other might involve a treatment called 'Fecal Microbiota Transplantation' (FMT), where healthy gut bacteria are introduced into a patient's gut, although the details of this are not fully described here. The study does not mention specific visits, follow-up schedules, or total duration, but it will involve providing samples and potentially dietary information.

Potential risks and benefits

There are no direct personal benefits from taking part in this study, but your contribution will help us learn more about MASLD and potentially lead to new treatments for this common liver condition, benefiting many people in the future. As with any medical study involving sample collection, there might be minor discomforts like a brief sting from blood draws. There's also the chance of unforeseen risks, which will be explained in detail before you agree to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Centre Hospitalier Lyon Sud Service Endocrinologie, Diabète et nutrition
Verified postcode
Pierre-Bénite, France

Common questions

What is MASLD?

MASLD is a common liver condition where too much fat builds up in the liver. It's often linked to being overweight or having type 2 diabetes.

What are 'gut bacteria'?

These are trillions of tiny living organisms that live in your intestines and help with digestion and overall health. We sometimes call them the 'gut microbiota'.

Why are you looking at stool, blood, and urine samples?

We're collecting these samples to find specific chemicals produced by your gut bacteria. These chemicals might affect your liver and could be key to understanding MASLD.

Will taking part in this study cure my MASLD?

No, this is a research study to understand the causes of MASLD. It's not designed to treat your condition, but it could help develop future treatments.

What is a 'dietary assessment'?

This is where we ask you about the foods you usually eat. It helps us understand how your diet might influence your gut bacteria and the chemicals they produce.

How to find out more

Cyrielle CAUSSY, MD, PhD

cyrielle.caussy@chu-lyon.fr +33 4 78 86 44 48 Official trial record

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