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NCT02608658 · ClinicalTrials.gov registry record · NA
Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites
A NA study, sponsored by St. Louis University.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT02608658 is a NA study that has completed, run by St. Louis University. The registered enrollment target is 11 participants.
The verdict
NCT02608658, a NA study, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
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.
Interventions
- OTHER Medical food, EnteraGam (Serum-Derived Bovine Immunoglobulin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2016-03 |
| Est. Completion | 2017-04-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02608658
The ClinicalTrials.gov registry entry for NCT02608658 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Medical food, EnteraGam (Serum-Derived Bovine Immunoglobulin) is the first listed.
NCT02608658 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02608658 about?
NCT02608658 is a clinical study titled "Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites". 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 ...
What is the current status of trial NCT02608658?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2016-03. Estimated completion is 2017-04-27.
What interventions are being tested in trial NCT02608658?
The interventions under investigation include: Medical food, EnteraGam (Serum-Derived Bovine Immunoglobulin) (OTHER).
Who is sponsoring clinical trial NCT02608658?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
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