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

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ClinicalTrials.gov Identifier: NCT02017405
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Healthy Other: Serum-derived bovine immunoglobulin protein isolate (SBI) Other: Matching Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: A Randomized, Crossover Clinical Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) in Healthy Adults
Study Start Date : December 2013
Primary Completion Date : March 2014
Arms and Interventions

Arm Intervention/treatment
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.

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 Name: EnteraGam™
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.

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 Name: EnteraGam™
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.

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


Outcome Measures

Primary Outcome Measures :
  1. Amino Acid Metabolism [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Bovine IgG Plasma Concentration [ Time Frame: 1 day ]
  2. Bovine IgG Plasma Concentration [ Time Frame: 2 weeks ]
  3. Bovine IgG Concentration in Stool [ Time Frame: 2 weeks ]

Other Outcome Measures:
  1. Incidence of Adverse Events [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017405


Locations
United States, North Carolina
PMG Research of Cary
Cary, North Carolina, United States, 27518
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
Entera Health, Inc
More Information

Additional Information:
Responsible Party: Entera Health, Inc
ClinicalTrials.gov Identifier: NCT02017405     History of Changes
Other Study ID Numbers: EH4001
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014

Keywords provided by Entera Health, Inc:
Digestibility
Healthy volunteers
serum-derived bovine immunoglobulin protein isolate
bovine IgG
adults

Additional relevant MeSH terms:
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs