Trial record 51 of 77 for:    gastroenterology | Recruiting | Exclude Unknown | United States

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by St. Louis University
Sponsor:
Collaborators:
American College of Gastroenterology
Entera Health, Inc
Information provided by (Responsible Party):
St. Louis University
ClinicalTrials.gov Identifier:
NCT02608658
First received: November 12, 2015
Last updated: April 5, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Cirrhosis of the Liver
Ascites
Spontaneous Bacterial Peritonitis
Other: Medical food, EnteraGam (Serum-Derived Bovine Immunoglobulin)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites

Resource links provided by NLM:


Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • Change in Markers of Bacterial Translocation [ Time Frame: At the start and end of the study (time 0 and at time 8 weeks) for each individual patient, the following labs will be drawn and assessed for change ] [ Designated as safety issue: No ]
    • LBP (Lipopolysaccharide binding protein)
    • Soluble CD14
    • Procalcitonin
    • high sensitivity C-Reactive Protein (CRP)
    • Intestinal Fatty Acid Binding Protein (I-FABP)


Secondary Outcome Measures:
  • Change in the prevalence of Small Intestinal Bacterial Overgrowth [ Time Frame: At the start and end of the study (time 0 and at time 8 weeks) for each individual patient ] [ Designated as safety issue: No ]
    Hydrogen breath test (using lactulose as the substrate)

  • Change to Quality of Life [ Time Frame: At the start and end of the study (time 0 and at time 8 weeks) for each individual patient ] [ Designated as safety issue: No ]
    Quality of life will be determined with the use of the Chronic Liver Disease Questionnaire (CLDQ), a validated questionnaire used in subjects with cirrhosis. The CLDQ includes 29 questions in six domains: abdominal symptoms (three questions), fatigue (five questions), systemic symptoms (five questions), activity (three questions), emotional function (eight questions), and worry (five questions).


Estimated Enrollment: 12
Study Start Date: March 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional Arm
The experimental arm of this study will involve all patients in this study. Subjects will be evaluated in a clinical setting and undergo a brief healthcare questionnaire, blood work, and a breath test. Subjects will then take a medical food (EnteraGam) twice daily for 8 weeks total, after which they will be seen in clinic at 4 weeks for follow up and then at 8 weeks to repeat the healthcare questionnaire, breath tests, and blood draw.
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
Other Name: Serum-Derived Bovine Immunoglobulin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will have signed and dated an Institutional Review Board (IRB) approved informed consent form (ICF) prior to beginning any study-related activities
  • Subjects will be males and females between the ages of 18 to 70 years (inclusive)
  • Subjects must have a confirmed diagnosis of cirrhosis as determined by radiographical (presence of a nodular appearing liver on imaging), clinical (must have documentation from a provider and information verified independently by chart review), or histological evidence (presence of bridging fibrosis on a prior biopsy)
  • Subjects must have ascites based off of clinical or radiographical evidence
  • Subjects with a Model for End-Stage Liver Disease (MELD) score of less than 17 as documented by most recent lab results. Subjects must be capable of understanding the requirements of the study, be willing to comply with all the study procedures, and be willing to attend all study visits.
  • Females of childbearing (reproductive) potential must have a negative pregnancy test at screening and agree to use an acceptable method of contraception throughout their participation in the study. Acceptable methods of contraception include:

    • double barrier methods (condom with spermicidal jelly or a diaphragm with spermicide),
    • hormonal methods (e. g. oral contraceptives, patches or medroxyprogesterone acetate), or
    • an intrauterine device (IUD) with a documented failure rate of less than 1% per year.
    • Abstinence or partner(s) with a vasectomy may be considered an acceptable method of contraception at the discretion of the investigator.

NOTE: Female subjects who have been surgically sterilized (e.g. hysterectomy or bilateral tubal ligation) or who are postmenopausal (total cessation of menses for >1 year) will not be considered "females of childbearing potential".

Exclusion Criteria:

  • Subjects with a MELD score of 17 or greater as documented by most recent lab results, within 45 days of their consent date.
  • Subjects with a history of TIPS (transjugular intrahepatic portosystemic shunt) placement
  • Subjects with a history of inflammatory bowel disease
  • Subjects who have signs and symptoms of active infection, such as fever (temperature greater than 100.4oF) or meeting criteria for Systemic Inflammatory Response Syndrome (defined as two of the following four:

    • (1) a temperature greater than 100.4oF,
    • (2) heart rate of greater than 90 beats per minute,
    • (3) respiratory rate greater than 20 breaths per minute, or
    • (4) leukocytosis or leukopenia defined as a WBC greater than 12,000 cells/mm3 or less than 4,000 cells/mm3).
  • Subjects who are on chronic antibiotics for any reason (including for prophylaxis of SBP or hepatic encephalopathy)
  • Subjects who have a history of hepatic encephalopathy requiring daily lactulose or daily rifaximin for therapy
  • Subjects who have active substance abuse or psychiatric disorders felt to preclude the ability to complete this study, including any drug abuse and active alcohol use greater than 1 drink daily
  • Subjects who have a poorly controlled medical condition that is felt to interfere with study procedures
  • Subjects who have a known allergy or hypersensitivity to beef or any component of SBI
  • Subjects who are pregnant or nursing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02608658

Contacts
Contact: Matthew J Stotts, MD 314-577-8764 mstotts@slu.edu
Contact: Amanda Cheung, MD 314-577-8764 amandacheung@slu.edu

Locations
United States, Missouri
Saint Louis University Salus Center, GI/Hepatology Clinical Studies Unit Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Kristina Wriston, RN    314-977-9400    kwriston@slu.edu   
Contact: Matthew J Stotts, MD    314-577-8764    mstotts@slu.edu   
Sponsors and Collaborators
St. Louis University
American College of Gastroenterology
Entera Health, Inc
Investigators
Principal Investigator: Matthew J Stotts, MD Saint Louis University Division of Gastroenterology
  More Information

Responsible Party: St. Louis University
ClinicalTrials.gov Identifier: NCT02608658     History of Changes
Other Study ID Numbers: StLouisU 25320 
Study First Received: November 12, 2015
Last Updated: April 5, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by St. Louis University:
Cirrhosis
Ascites
SBP

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Ascites
Peritonitis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Intraabdominal Infections
Infection
Peritoneal Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2016