Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults
- Conditions
- Healthy
- Interventions
- Other: Serum-derived bovine immunoglobulin protein isolate (SBI)Other: Matching Placebo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Body mass index of 18-32
- Medically normal with no significant abnormal findings at screening
- 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
- Arm && Interventions
Group Intervention Description 10g Serum-derived bovine immunoglobulin protein isolate (SBI) Serum-derived bovine immunoglobulin protein isolate (SBI) Phase 1: Twelve subjects will receive either a 10.0 g total daily dose of SBI on Day 1 followed by 10.0 g Placebo on Day 2 or a 10.0 g total daily dose of Placebo on Day 1 followed by 10.0 g SBI on Day 2 during the double-blind, crossover phase. Phase 2: 5.0 g SBI will taken two times a day for 14 days during the open-label phase. 5g Serum-derived bovine immunoglobulin protein isolate (SBI) Serum-derived bovine immunoglobulin protein isolate (SBI) Phase 1: Twelve subjects will receive either a 5.0 g total daily dose of SBI on Day 1 followed by 5.0 g Placebo on Day 2 or a 5.0 g total daily dose of Placebo on Day 1 followed by 5.0 g SBI on Day 2 during the double-blind, crossover phase. Phase 2: 2.5g SBI will be taken two times a day for 14 days during the open-label phase. 20g Serum-derived bovine immunoglobulin protein isolate (SBI) Serum-derived bovine immunoglobulin protein isolate (SBI) Phase 1: Twelve subjects will receive either a 20.0 g total daily dose of SBI on Day 1 followed by 20.0 g Placebo on Day 2 or a 20.0 g total daily dose of Placebo on Day 1 followed by 20.0 g SBI on Day 2 during the double-blind, crossover phase. Phase 2: 20.0 g SBI will be taken two times a day for 14 days during the open-label phase. Matching Placebo Matching Placebo Placebo will be taken either on Day 1 or on Day 2 based on the randomization during the double-blind, crossover phase.
- 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