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

March 10, 2014 updated by: Entera Health, Inc

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Cary, North Carolina, United States, 27518
        • PMG Research of Cary
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 5g 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.

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™
Other: 10g 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.

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™
Other: 20g 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.

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™
Other: Matching Placebo
Placebo will be taken either on Day 1 or on Day 2 based on the randomization during the double-blind, crossover phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amino Acid Metabolism
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Bovine IgG Plasma Concentration
Time Frame: 1 day
1 day
Bovine IgG Plasma Concentration
Time Frame: 2 weeks
2 weeks
Bovine IgG Concentration in Stool
Time Frame: 2 weeks
2 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 11, 2014

Last Update Submitted That Met QC Criteria

March 10, 2014

Last Verified

March 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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