BridgeMD
New treatment option for MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Official title Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD
ClinicalTrials.gov ID: NCT07313007
What this study is testing
- What it's testing
- Metabolic dysfunction-associated steatotic liver disease (MASLD) encompasses a spectrum of liver disorders ranging from simple steatosis-a relatively benign and non-progressive condition-to metabolic dysfunction-associated steatohepatitis (MASH), characterized by hepatocellular inflammation. MASLD is now the leading cause of chronic liver disease worldwide, affecting approximately one in three adults, particularly those with obesity or type 2 diabetes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- For patients and healthy volunteers:
- Age between 18 and 80 years.
- Non-diabetic participant (fasting blood glucose \< 1.26 g/L, or absence of insulin therapy or oral antidiabetic medication).
- Body mass index (BMI) between 18 and 30 kg/m².
- For women of childbearing potential, use of at least one recognized effective contraceptive method.
You likely can't join if
- For patients and healthy volunteers:
- Participant with active inflammatory, infectious, cardiovascular, or neoplastic disease.
- Participant with a history of colectomy, small bowel resection, or cholecystectomy.
- Participant who received antibiotics, prebiotics, or probiotics within the past 3 months.
- Participant using laxatives (more than 2 doses per day over the past 3 months).
- Participant with chronic constipation.
See the full eligibility criteria
- For patients and healthy volunteers:
- Age between 18 and 80 years.
- Non-diabetic participant (fasting blood glucose \< 1.26 g/L, or absence of insulin therapy or oral antidiabetic medication).
- Body mass index (BMI) between 18 and 30 kg/m².
- For women of childbearing potential, use of at least one recognized effective contraceptive method.
- Very regular bowel movements every 24 to 48 hours.
- Participant living within 100 km of the Lyon Sud Hospital Center (CHLS).
- Participant willing to participate in the study and providing written informed consent.
- Participant affiliated with the general French Social Security system or an equivalent scheme.
- For patients:
- Presence of MASLD according to the definition of the European Association for the Study of the Liver (EASL), defined by hepatic steatosis on imaging performed within the previous year (abdominal ultrasound, abdominal CT...
- No history of liver transplantation.
- No excessive alcohol consumption (less than 20 g/day for women and less than 30 g/day for men).
- Patient followed in the Endocrinology, Diabetes and Nutrition Department at Lyon Sud Hospital.
- For patients and healthy volunteers:
- Participant with active inflammatory, infectious, cardiovascular, or neoplastic disease.
- Participant with a history of colectomy, small bowel resection, or cholecystectomy.
- Participant who received antibiotics, prebiotics, or probiotics within the past 3 months.
- Participant using laxatives (more than 2 doses per day over the past 3 months).
- Participant with chronic constipation.
- Pregnant, parturient, or breastfeeding women.
- Participant deprived of liberty by judicial or administrative decision.
- Participant receiving psychiatric care.
- Participant institutionalized for reasons other than research.
- Adult participant under legal protection (guardianship or trusteeship).
- Participant who does not understand the French language and cannot provide informed consent.
- Participant already enrolled in a study presenting a conflict of interest with the present study.
- For healthy volunteers
- Known liver disease
- No long-term drug medication except oral contraception for women.
The study team makes the final eligibility decision.
Where it's taking place
- Pierre-Bénite, France
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, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pierre-Bénite, France. 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.