MODIFY MODIFY: A Case-Control, Observational, Proof of Mechanism Study to Define Microbiome-Mediated Gut Dysfunction Across the Spectrum of Non-Alcoholic Fatty Liver Disease.

MODIFY: A Case-Control, Observational, Proof of Mechanism Study to Define Microbiome-Mediated Gut Dysfunction Across the Spectrum of Non-Alcoholic Fatty Liver Disease.

Associated Conditions

Liver-NAFL, NASH

Principal Investigator

Sponsor

Merck

This study is being done to understand if the bacteria that are in your colon (the gut microbiome) get into the cells of the intestinal wall in people with fatty liver or fibrosis compared to people with healthy livers. When the bacteria get into the cells of your intestine, they may contribute to liver disease. This may help us better understand how to prevent or treat liver disease by targeting the microbes that are in your colon (the gut microbiome).

Study Duration: up to 8 weeks

Study Committment: 1 Screening visit and 2 outpatient visits.

Age: 35-65 years old

Sex: Male & Female

Conditions/Eligibility: Healthy and/or history of non-alcoholic fatty liver disease and BMI between 27.5 to 39.9

Study Procedures:
Height/Weight
Waist/Hip measurements
Vital signs
Physical Exams
Questionnaires
MRI
Sigmoid colon biopsies
Urine, blood and stool sample collection

Compensation: $675