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

Entera Health

Status: Completed

Conditions: Healthy

Treatments: Other: Serum-derived bovine immunoglobulin protein isolate (SBI); Other: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02017405

EH4001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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42 participants in 4 patient groups

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

Other group

Description:

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.

Treatment:

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

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

Other group

Description:

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.

Treatment:

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

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

Other group

Description:

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.

Treatment:

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

Matching Placebo

Other group

Description:

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

Treatment:

Other: Matching Placebo