NCT02017405

Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults

A Randomized, Crossover Clinical Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Entera Health, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Serum-derived bovine immunoglobulin protein isolate (SBI)	Serum-derived bovine immunoglobulin protein isolate is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. Serum-derived bovine immunoglobulin protein isolate does not contain any milk products such as lactose, casein, or whey. Serum-derived bovine immunoglobulin protein isolate is gluten-free, dye-free, and soy-free. Serum-derived bovine immunoglobulin protein isolate is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
OTHER	Matching Placebo

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-03-01
• Completion: 2014-11-01
• First posted: 2013-12-20
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

2 sites across 1 country: United States