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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: Completed NA study, sponsored by St. Louis University.
NCT02608658 is a NA study that has completed, run by St. Louis University. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
* LBP (Lipopolysaccharide binding protein) * Soluble CD14 * Procalcitonin * high sensitivity C-Reactive Protein (CRP) * Intestinal Fatty Acid Binding Protein (I-FABP)
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 |
What the finished NCT02608658 record still lists
NCT02608658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Medical food, EnteraGam (Serum-Derived Bovine Immunoglobulin) is the first listed.
NCT02608658 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02608658's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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