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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Quantifiable Bovine IgG Plasma Concentration | Plasma samples from participants were tested for bovine IgG content using an ELISA kit with a sheep polyclonal antibody that specifically binds to bovine IgG heavy chain. The limit of quantification was determined to be 3.8 ng/ml and 4.6 ng/ml, in the two separate Elisa kits used (lot numbers 140821 and 140605). | 0 and 90 minutes following investigational product dosing during crossover phase; and after 14 days of open label dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Weaver, PHD | Entera Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PMG Research of Cary | Cary | North Carolina | 27518 | United States | ||
| Wake Research Associates |
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| Label | URL |
|---|---|
| EnteraGam™ | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 1A | Crossover Phase: 5.0g total daily dose of SBI on Day 1 followed by 5.0g Placebo on Day 2 Open Label Phase: 5.0g total daily dose of SBI will be taken for 14 days |
| FG001 | 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 1B | Crossover Phase: 5.0g total daily dose of Placebo on Day 1 followed by 5.0g SBI on Day 2 Open Label Phase: 5.0g total daily dose of SBI will be taken for 14 days |
| FG002 | 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 2A | Crossover Phase: 10.0g total daily dose of SBI on Day 1 followed by 10.0g Placebo on Day 2 Open Label Phase: 10.0g total daily dose of SBI will be taken for 14 days |
| FG003 | 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 2B | Crossover Phase: 10.0g total daily dose of Placebo on Day 1 followed by 10.0g SBI on Day 2. Open Label Phase: 10.0g total daily dose of SBI will be taken for 14 days |
| FG004 | 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 3A | Crossover Phase: 20.0g total daily dose of SBI on Day 1 followed by 20.0g placebo on day 2. Open Label Phase: 20.0g total daily dose of SBI will be taken for 14 days |
| FG005 | 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 3B | Crossover Phase: 20.0g total daily dose of Placebo on Day 1 followed by 20.0g SBI on Day 2 Open Label Phase: 20.0g total daily dose of SBI will be taken for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Two-day, Double-blind, Crossover Phase |
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| Open-label Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | During 2-day cross-over phase, subjects were randomized to receive placebo one day and active on the other. This includes all subjects who received both a placebo and an active dose. | Posted | Mean | Standard Deviation | umol/mL | 0, 180 minutes following administration of the investigational product in crossover phase. |
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16 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Crossover Phase | Subjects that received 5g SBI on either day 1 or day 2 of the crossover phase and reported AE during crossover phase. This includes groups 1A and 1B in the crossover phase. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Audrey L. Shaw, Ph.D. | Entera Health, Inc. | 919 971 8000 | audrey.shaw@enterahealth.com |
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| Matching Placebo | Other |
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| Bovine IgG Concentration in Stool | Change from baseline in Stool bovine IgG concentration following 14 days of open label dosing. | 14 days after starting the open label phase |
| Raleigh |
| North Carolina |
| 27612 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Subjects who will receive either a 10.0g total daily dose of SBI on Day 1 or 10.0g SBI on Day 2 during the double-blind, crossover phase. This includes group 2A and 2B. |
| OG002 | 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Subjects who will receive either a 20.0g total daily dose of SBI on Day 1 or 20.0g SBI on Day 2 during the double-blind, crossover phase. This includes group 3A and 3B. |
| OG003 | Placebo | Subjects who will receive a placebo dose(5,10, or 20g) on either day one or two of the crossover phase. This includes all subjects who finished the crossover phase, as all subjects received a placebo. |
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| Secondary | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | Plasma samples from participants were tested for bovine IgG content using an ELISA kit with a sheep polyclonal antibody that specifically binds to bovine IgG heavy chain. The limit of quantification was determined to be 3.8 ng/ml and 4.6 ng/ml, in the two separate Elisa kits used (lot numbers 140821 and 140605). | Subjects who received at least one dose of SBI. Variations in numbers from the participation flow are due to missing data of certain individuals. | Posted | Count of Participants | Participants | 0 and 90 minutes following investigational product dosing during crossover phase; and after 14 days of open label dosing |
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| Secondary | Bovine IgG Concentration in Stool | Change from baseline in Stool bovine IgG concentration following 14 days of open label dosing. | Subjects who received at least one dose of product and had at least one stool IgG measurement. No placebo as there is no placebo group in the open label phase. | Posted | Mean | Standard Deviation | pg/mg | 14 days after starting the open label phase |
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| 0 |
| 18 |
| 0 |
| 18 |
| 4 |
| 18 |
| EG001 | 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Crossover Phase | Subjects that received 10g on either day 1 or day 2 of the crossover phase and reported AE during crossover phase. This includes groups 2A and 2B in the crossover phase. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Crossover Phase | Subjects that received 20g on either day 1 or day 2 of the crossover phase and reported AE during crossover phase. This includes groups 3A and 3B in the crossover phase. | 0 | 11 | 0 | 14 | 3 | 11 |
| EG003 | Placebo - Crossover Phase | Subjects that received 5, 10, or 20g placebo dose on either day 1 or day 2 of the crossover phase and reported AE during crossover phase. This includes all subjects in the crossover phase. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG004 | 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Open Label Phase | Patients that took 2.5g SBI BID (5g daily) during 14 day open label phase. Reported AE during 14 day open label phase. This includes groups 1A and 1B in the open label phase. | 0 | 14 | 0 | 14 | 7 | 14 |
| EG005 | 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Open Label Phase | Patients that took 5g SBI BID (10g daily) during 14 day open label phase. Reported AE during 14 day open label phase. This includes groups 2A and 2B in the open label phase. | 0 | 14 | 0 | 14 | 4 | 14 |
| EG006 | 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Open Label Phase | Patients that took 10g SBI BID (20g daily) during 14 day open label phase. Reported AE during 14 day open label phase. This includes groups 3A and 3B in the open label phase. | 0 | 13 | 0 | 13 | 5 | 13 |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment | The subject in the 5g-crossover phase section reported the AE at the time they received the placebo dose but 1 day after receiving the SBI dose. This leads to an inconclusive conclusion of what caused this AE. |
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| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Sinus infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Pain in left leg | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Flu | Immune system disorders | MedDRA | Non-systematic Assessment |
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| Running nose | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Sore throat | General disorders | MedDRA | Non-systematic Assessment |
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| Bloated Feeling | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Common Cold | General disorders | MedDRA | Non-systematic Assessment | The subject in the 5g-crossover phase section reported the AE at the time they received the placebo dose but 1 day after receiving the SBI dose. This leads to an inconclusive conclusion of what caused this AE. |
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| Flatulence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment | One subject in the 20g-crossover phase section reported the AE at the time they received the placebo dose but 1 day after receiving the SBI dose. This leads to an inconclusive conclusion of what caused this AE. |
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| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment | The subject in the 5g-crossover phase section reported the AE at the time they received the placebo dose but 1 day after receiving the SBI dose. This leads to an inconclusive conclusion of what caused this AE. |
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| Lightheadedness | General disorders | MedDRA | Non-systematic Assessment |
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| Knee Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Gum Shifting | General disorders | MedDRA | Non-systematic Assessment |
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| Cramp | General disorders | MedDRA | Non-systematic Assessment |
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| Abdominal Cramp | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Hypoglycemia | General disorders | MedDRA | Non-systematic Assessment |
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| Bladder Irritation | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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45 days
| Title | Measurements |
|---|---|
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| 90 minutes |
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| Post 14 days of open label dosing |
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