The Effect of Obeticholic Acid in Healthy Volunteers
Status:
Recruiting
Trial end date:
2023-07-22
Target enrollment:
Participant gender:
Summary
This study investigates whether obeticholic acid affects gut microbiota, gastric motility,
accommodation, and gastrointestinal peptide in healthy subjects.
This study is a single-blind, placebo-controlled, randomized study. Twelve healthy volunteers
will take one tablet containing obeticholic acid (10 mg) or a placebo once per day for 21
days for the first intervention. After 28 days washout period, they will take a tablet
different from the one taken in the first intervention.
Before the first intervention, they will receive MMC, IGP and endoscopy exam. At the end of
the first and second interventions, they will receive the same exams. During MMC&IGP, we will
take blood samples to measure plasma hormones (motilin, octa-ghrelin, GLP-1, GLP-2, GIP, and
insulin) and take duodenal fluid. When the endoscopy, we will take samples from the duodenal
for microbiota, permeability measurement, RNA, protein, and pathology.
Before and during the interventions, stool samples will be collected.