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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):
Entera Health, Inc

Tracking Information
First Submitted Date  ICMJE December 10, 2013
First Posted Date  ICMJE December 20, 2013
Last Update Posted Date March 11, 2014
Study Start Date  ICMJE December 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
Amino Acid Metabolism [ Time Frame: 1 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
  • Bovine IgG Plasma Concentration [ Time Frame: 1 day ]
  • Bovine IgG Plasma Concentration [ Time Frame: 2 weeks ]
  • Bovine IgG Concentration in Stool [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 19, 2013)
Incidence of Adverse Events [ Time Frame: 2 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults
Official Title  ICMJE A Randomized, Crossover Clinical Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) in Healthy Adults
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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™
  • Other: Matching Placebo
Study Arms  ICMJE
  • 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.

    Intervention: Other: Serum-derived bovine immunoglobulin protein isolate (SBI)
  • 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.

    Intervention: Other: Serum-derived bovine immunoglobulin protein isolate (SBI)
  • 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.

    Intervention: Other: Serum-derived bovine immunoglobulin protein isolate (SBI)
  • Matching Placebo
    Placebo will be taken either on Day 1 or on Day 2 based on the randomization during the double-blind, crossover phase.
    Intervention: Other: Matching Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2014)
42
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2013)
36
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02017405
Other Study ID Numbers  ICMJE EH4001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Entera Health, Inc
Study Sponsor  ICMJE Entera Health, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Entera Health, Inc
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP