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Completed

NCT Number: NCT02017405

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PMG Research of Cary, Cary, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum-derived bovine immunoglobulin protein isolate (SBI)

Other

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 names: EnteraGam™

Matching Placebo

Other

Primary outcomes

  1. Concentration of Total Plasma Amino Acids

    Time frame: 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 outcomes

  1. Number of Participants With Quantifiable Bovine IgG Plasma Concentration

    Time frame: 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).

  2. Bovine IgG Concentration in Stool

    Time frame: 14 days after starting the open label phase

    Change from baseline in Stool bovine IgG concentration following 14 days of open label dosing.

Sponsors and collaborators

Lead sponsor

Entera Health, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 20, 2013
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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