Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated … (NCT02608658) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites
United States11 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Markers of Bacterial Translocation
Timeframe: 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