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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT02017405
• Lead Sponsor: Entera Health, Inc

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-20
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Last Update Submitted: 2014-03-10
• Last Update Posted: 2014-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Body mass index of 18-32
• Medically normal with no significant abnormal findings at screening

Exclusion Criteria

• Allergy or intolerance to beef
• Participated in another investigational study within 30 days
• Seropostive for HIV, hepatitis B surface antigen, hepatitis C virus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Concentration of Total Plasma Amino Acids	0, 180 minutes following administration of the investigational product in crossover phase.	Plasma amino acid concentrations (umol/mL) were measured after administration of SBI or Placebo during the Cross-over phase.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Quantifiable Bovine IgG Plasma Concentration	0 and 90 minutes following investigational product dosing during crossover phase; and after 14 days of open label dosing	Plasma samples from participants were tested for bovine IgG content using an ELISA kit with a sheep polyclonal antibody that specifically binds to bovine IgG heavy chain. The limit of quantification was determined to be 3.8 ng/ml and 4.6 ng/ml, in the two separate Elisa kits used (lot numbers 140821 and 140605).
Bovine IgG Concentration in Stool	14 days after starting the open label phase	Change from baseline in Stool bovine IgG concentration following 14 days of open label dosing.

Trial Locations

Locations (2)

PMG Research of Cary; 🇺🇸 Cary, North Carolina, United States

Wake Research Associates; 🇺🇸 Raleigh, North Carolina, United States