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

NCT02017405 | Completed Results

• 1 other identifier: EH4001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Digestibility; Healthy volunteers; serum-derived bovine immunoglobulin protein isolate; bovine IgG; adults

Outcome Measures

Primary Outcomes (1)

• Concentration of Total Plasma Amino Acids

  Plasma amino acid concentrations (umol/mL) were measured after administration of SBI or Placebo during the Cross-over phase.

  0, 180 minutes following administration of the investigational product in crossover phase.

Secondary Outcomes (2)

• 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

• Bovine IgG Concentration in Stool

  14 days after starting the open label phase

Study Arms (4)

5g Serum-derived bovine immunoglobulin protein isolate (SBI)

OTHER

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)

10g Serum-derived bovine immunoglobulin protein isolate (SBI)

OTHER

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)

20g Serum-derived bovine immunoglobulin protein isolate (SBI)

OTHER

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)

Matching Placebo

OTHER

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

Interventions

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.

Also known as: EnteraGam™

10g Serum-derived bovine immunoglobulin protein isolate (SBI); 20g Serum-derived bovine immunoglobulin protein isolate (SBI); 5g Serum-derived bovine immunoglobulin protein isolate (SBI)

Matching Placebo OTHER

Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index of 18-32
• Medically normal with no significant abnormal findings at screening

You may not qualify if:

• Allergy or intolerance to beef
• Participated in another investigational study within 30 days
• Seropostive for HIV, hepatitis B surface antigen, hepatitis C virus

Sponsors & Collaborators

• Entera Health, Inc: lead

Study Sites (2)

PMG Research of Cary

Cary, North Carolina, 27518, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Related Links

• EnteraGam™

Results Point of Contact

• Title: Audrey L. Shaw, Ph.D.
• Organization: Entera Health, Inc.

audrey.shaw@enterahealth.com

919 971 8000

Study Officials

• Eric Weaver, PHD

  Entera Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 20, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)