Status:
RECRUITING
Fecal Microbiota Analysis of PNPLA3 Polymorphism in Hispanic Patients With MASLD
Lead Sponsor:
Fundacion de Investigacion Science and Education
Conditions:
Metabolic Dysfunction-associated Steatotic Liver Disease
Eligibility:
All Genders
21-75 years
Brief Summary
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 expl...
Detailed Description
The liver is the powerhouse of the body, overseeing many functions such as the production of clotting factors, sugars, fats, and the metabolism of drugs. MASLD is the most common chronic liver disease...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 20 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06495333
Start Date
July 5 2024
End Date
August 20 2025
Last Update
July 10 2024
Active Locations (1)
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1
FDI Clinical Research
San Juan, Puerto Rico, 00927