Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT02017405
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2013-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults
Sponsor:
Entera Health, Inc
Organization:
Study Overview
Official Title:
A Randomized, Crossover Clinical Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the digestibility of serum-derived bovine immunoglobulin protein isolate in healthy adults. The information generated may help elucidate SBI's mechanism of action.
Detailed Description:
This study is evaluating the safety and absorption of serum-derived bovine immunoglobulin protein isolate (SBI) in healthy adults using 5, 10, and 20 g doses of SBI and placebo equivalents in a double blind crossover study and SBI affects over 14 days. Additionally, plasma amino acid response and IgG concentrations in both stool and plasma will be investigated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: