Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites

NACompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

April 27, 2017

Study Completion Date

April 27, 2017

Conditions
Cirrhosis of the LiverAscitesSpontaneous Bacterial Peritonitis
Interventions
OTHER

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"

Trial Locations (1)

63104

Saint Louis University Salus Center, GI/Hepatology Clinical Studies Unit, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

American College of Gastroenterology

OTHER

collaborator

Entera Health, Inc

INDUSTRY

lead

St. Louis University

OTHER