Gut microbiota–derived amino acid metabolites in MASLD/MASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional/observational framework collects stool samples, dietary data, and blood and urine to explore how gut microbiota–derived amino acid metabolites relate to MASLD and MASH. Participants include adults with MASLD as defined by imaging evidence and non-diabetic controls, within a 100 km radius of Lyon Sud Hospital. The study examines metabolites linked to tryptophan and phenylalanine pathways and their associations with liver disease severity and gut-liver axis biology. No therapeutic intervention is described beyond sample collection and dietary assessment, with an emphasis on profiling metabolic signatures. Results could inform future strategies targeting the gut microbiome in MASLD/MASH.

Why it matters

Who can join: the full rules

Inclusion 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 scan, magnetic resonance imaging, or controlled attenuation parameter (CAP) measured by FibroScan) and at least one cardiometabolic criterion among: dyslipidemia, arterial hypertension, overweight (BMI ≥ 25 kg/m²), impaired glucose tolerance, or type 2 diabetes.
  * 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.

Exclusion Criteria:

* 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.

Where it's running

• Centre Hospitalier Lyon Sud Service Endocrinologie, Diabète et nutrition
  Pierre-Bénite, France Recruiting

Study contacts

• Study coordinator: Cyrielle CAUSSY, MD, PhD
• Email: cyrielle.caussy@chu-lyon.fr
• Phone: +33 4 78 86 44 48

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.