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

NCT02608658 | Completed

• 1 other identifier: StLouisU 25320
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cirrhosis; Ascites; SBP

Outcome Measures

Primary Outcomes (1)

• Change in Markers of Bacterial Translocation

  * LBP (Lipopolysaccharide binding protein) * Soluble CD14 * Procalcitonin * high sensitivity C-Reactive Protein (CRP) * Intestinal Fatty Acid Binding Protein (I-FABP)

  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

Secondary Outcomes (2)

• Change in the prevalence of Small Intestinal Bacterial Overgrowth

  At the start and end of the study (time 0 and at time 8 weeks) for each individual patient

• Change to Quality of Life

  At the start and end of the study (time 0 and at time 8 weeks) for each individual patient

Study Arms (1)

Interventional Arm

EXPERIMENTAL

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)

Interventions

Medical food, EnteraGam (Serum-Derived Bovine Immunoglobulin) OTHER

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

Also known as: Serum-Derived Bovine Immunoglobulin

Interventional Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead
• American College of Gastroenterology: collaborator
• Entera Health, Inc: collaborator

Study Sites (1)

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

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Fibrosis; Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad Hummami, MD

  Saint Louis University Division of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Housestaff Resident

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 20, 2015
• Study Start: March 1, 2016
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)