11
Participants
Start Date
March 31, 2016
Primary Completion Date
April 27, 2017
Study Completion Date
April 27, 2017
Medical food, EnteraGam (Serum-Derived Bovine Immunoglobulin)
"Visit 1, screening (Day 0): At this visit, the investigators of the study will:~* Obtain demographic information, as will past medical history and medications.~* Perform a physical examination.~* Collect samples for labs~* Administer the Chronic Liver Disease Questionnaire (CLDQ)~* Perform a lactulose breath test~From Day 0 to 8 weeks: subjects will take the medical food twice daily~Visit 2, Week 4 (Day 28 +/- 3): At this visit, the investigators of the study will:~* Perform a physical examination~* Collect and record returned investigational product~* Dispense investigational product and instruct again regarding use~* Record any adverse events~Visit 3, Week 8 (Day 56 +/- 3): At this visit, the investigators of the study will:~* Perform a physical examination.~* Collect samples for labs~* Administer the Chronic Liver Disease Questionnaire (CLDQ)~* Perform a lactulose breath test"
Saint Louis University Salus Center, GI/Hepatology Clinical Studies Unit, St Louis
Collaborators (1)
American College of Gastroenterology
OTHER
Entera Health, Inc
INDUSTRY
St. Louis University
OTHER