Analyzing gut bacteria and genetics in Hispanic patients with fatty liver disease

Fecal Microbiota Analysis of PNPLA3 Polymorphism in Hispanic Patients With Metabolic Dysfunction Associated Steatotic Liver Disease

This study looks at how gut bacteria and a specific gene affect the severity of fatty liver disease in Hispanic patients in Puerto Rico.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 21 Years to 75 Years
• Sex: All
• Sponsor: Fundacion de Investigacion Science and Education (Academic / other)
• Locations: 1 site (San Juan)
• Trial ID: NCT06495333 on ClinicalTrials.gov

What this trial studies

This observational study focuses on Hispanic patients in Puerto Rico diagnosed with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD). It aims to explore the relationship between the gut microbiome and the PNPLA3 genetic variant, which is known to influence the severity of MASLD. Participants will undergo a non-invasive liver test and provide blood and fecal samples for analysis. The study seeks to clarify how genetic and microbiota factors contribute to the disease's progression in this population.

Who should consider this trial

Good fit: Ideal candidates are Hispanic individuals aged 21 to 75 living in Puerto Rico with diagnosed MASLD.

Not a fit: Patients with excessive alcohol intake, liver transplant history, or viral hepatitis are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of MASLD in Hispanic patients.

How similar studies have performed: While studies on MASLD and gut microbiota exist, this specific focus on the Hispanic population and the PNPLA3 variant is relatively novel.

Eligibility criteria

Inclusion Criteria:

A subject must meet the following criteria to be eligible for inclusion in the study:

Patient must be of Hispanic ethnicity residing in Puerto Rico. Age 21 to 75 years old at time of informed consent. Evidence of MASLD by vibration-controlled transient elastography (FibroScan) controlled attenuation parameter (CAP) (value must be greater than or equal to 248 dB/m).

Willing and able to provide informed consent signed by study subject. Willing and able to understand and complete study-related procedures.

Exclusion Criteria:

A subject who meets any of the following criteria will be excluded from the study:

Excessive alcohol intake for ≥3 months during past year prior to screening (\>3 units/day for males and \>2 units/day for female is generally considered excessive).

History of liver transplant, or current placement on a liver transplant list. History of viral and resolved hepatitis (Hepatitis B or C) or human immunodeficiency virus (HIV).

Use of antibiotics within 14 days of screening.

Where this trial is running

San Juan

• FDI Clinical Research — San Juan, Puerto Rico (Recruiting)

Study contacts

• Study coordinator: Vivian Tamayo, MD

Conditions Metabolic Dysfunction-associated Steatotic Liver Disease; MASLD; NAFLD