Actively Recruiting

Age: 21Years - 75Years
All Genders
NCT06495333

Fecal Microbiota Analysis of PNPLA3 Polymorphism in Hispanic Patients With MASLD

Led by Fundacion de Investigacion Science and Education · Updated on 2024-07-10

100

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of liver disease worldwide. The condition is defined by fat accumulation exceeding 5% of liver weight not explained by at-risk alcohol intake. Risk factors include obesity, diabetes, genetic variants, dietary factors, and gut microbiota alterations. However, the interdependence of these factors and their individual impact on disease severity remain unclear. The investigators aim to investigate the changes in the gut microbiome of Hispanics living in Puerto Rico with MASLD associated with wild-type and mutated genotype status of PNPLA3 rs738409, a strong genetic contributor to MASLD. In this cross-sectional study, blood and fecal samples will be collected from participants who have completed a non-invasive transient elastography test (FibroScan) to measure the extent of hepatic steatosis (fat in the liver). Genotyping for the PNPLA3 rs738409 variant will be conducted. Fecal samples will be collected to analyze the V4 region of the 16S rRNA gene for intestinal microbiota characterization. Alpha and beta diversity analysis will be measured by MASLD status and PNPLA3 genotype to evaluate biodiversity within and between samples.

CONDITIONS

Official Title

Fecal Microbiota Analysis of PNPLA3 Polymorphism in Hispanic Patients With MASLD

Who Can Participate

Age: 21Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be of Hispanic ethnicity residing in Puerto Rico
  • Be between 21 and 75 years old at the time of consent
  • Have evidence of MASLD by FibroScan with controlled attenuation parameter (CAP) value ≥ 248 dB/m
  • Be willing and able to provide signed informed consent
  • Be willing and able to understand and complete study procedures
Not Eligible

You will not qualify if you...

  • Have excessive alcohol intake for 3 or more months in the past year (over 3 units/day for males, over 2 units/day for females)
  • Have a history of liver transplant or be currently on a liver transplant list
  • Have a history of viral or resolved hepatitis B or C, or HIV infection
  • Have used antibiotics within 14 days before screening

AI-Screening

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Trial Site Locations

Total: 1 location

1

FDI Clinical Research

San Juan, Puerto Rico, 00927

Actively Recruiting

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Research Team

V

Vivian Tamayo, MD

CONTACT

G

Grisell Ortiz-Lasanta, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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