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

NCT02608658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-06-01

No results posted yet for this study

Summary

This protocol represents an open-label pilot study to assess whether oral administration of SBI in subjects with decompensated cirrhosis with ascites can lead improvements in the management of the disease. The impact of SBI therapy will be based on changes to markers of bacterial translocation, gut barrier damage, and inflammation as well as the impact on rates of SIBO. Study subjects will be given one packet of EnteraGam, each packet containing 5.0 g SBI, twice daily for 8 weeks.

Conditions

  • Cirrhosis of the Liver
  • Ascites
  • Spontaneous 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

Sponsors & Collaborators

  • American College of Gastroenterology

    collaborator OTHER

  • Entera Health, Inc

    collaborator INDUSTRY

  • St. Louis University

    lead OTHER

Principal Investigators

  • Muhammad Hummami, MD · Saint Louis University Division of Gastroenterology

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-04-27
Completion
2017-04-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02608658 on ClinicalTrials.gov