HealthyNCT02017405
Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults
A study testing Serum-derived bovine immunoglobulin protein isolate (SBI) in people with Healthy, run by Entera Health, Inc at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Serum-derived bovine immunoglobulin protein isolate (SBI)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index of 18-32
- Medically normal with no significant abnormal findings at screening
Who cannot join
- Allergy or intolerance to beef
- Participated in another investigational study within 30 days
- Seropostive for HIV, hepatitis B surface antigen, hepatitis C virus
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PMG Research of Cary
Cary, North Carolina, 27518
Wake Research Associates
Raleigh, North Carolina, 27612
About this study
Official title: A Randomized, Crossover Clinical Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) in Healthy Adults
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.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- Serum-derived bovine immunoglobulin protein isolate (SBI), Matching Placebo
- Keywords
- Digestibility, Healthy volunteers, serum-derived bovine immunoglobulin protein isolate, bovine IgG, adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum-derived bovine immunoglobulin protein isolate (SBI)Other
Also called EnteraGam™
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.
Matching PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 180 minutes following administration of the investigational product in crossover phase.
Secondary outcomes (2)
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).
Measured: 0 and 90 minutes following investigational product dosing during crossover phase; and after 14 days of open label dosing
Bovine IgG Concentration in Stool
Change from baseline in Stool bovine IgG concentration following 14 days of open label dosing.
Measured: 14 days after starting the open label phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entera Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Weaver, PHD, Study director, Entera Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017405
- Sponsor's protocol ID
- EH4001
- Status last verified
- Sep 2024
- First submitted
- 10 Dec 2013
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Clinical Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) in Healthy Adults
- ClinicalTrials.gov ID
- NCT02017405
- Acronym / sponsor ID
- EH4001
- Conditions
- Healthy
- Keywords
- Digestibility, Healthy volunteers, serum-derived bovine immunoglobulin protein isolate, bovine IgG, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Entera Health, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5g Serum-derived bovine immunoglobulin protein isolate (SBI) | Other | Other: 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. |
| 10g Serum-derived bovine immunoglobulin protein isolate (SBI) | Other | Other: 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. |
| 20g Serum-derived bovine immunoglobulin protein isolate (SBI) | Other | Other: 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. |
| Matching Placebo | Other | Other: Matching PlaceboPlacebo will be taken either on Day 1 or on Day 2 based on the randomization during the double-blind, crossover phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index of 18-32
- Medically normal with no significant abnormal findings at screening
Key exclusion criteria (3 listed)
- Allergy or intolerance to beef
- Participated in another investigational study within 30 days
- Seropostive for HIV, hepatitis B surface antigen, hepatitis C virus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum-derived bovine immunoglobulin protein isolate (SBI)Also: EnteraGam™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 | 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 |
Primary outcome
Concentration of Total Plasma Amino Acids
Time frame: 0, 180 minutes following administration of the investigational product in crossover phase.
Plasma amino acid concentrations (umol/mL) were measured after administration of SBI or Placebo during the Cross-over phase.
2 secondary outcomes
Number of Participants With Quantifiable Bovine IgG Plasma Concentration
Time frame: 0 and 90 minutes following investigational product dosing during crossover phase; and after 14 days of open label dosing
Bovine IgG Concentration in Stool
Time frame: 14 days after starting the open label phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- EnteraGam™Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Weaver, PHD study director
Entera Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum-derived bovine immunoglobulin protein isolate (SBI) in people with Healthy, run by Entera Health, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Total Plasma Amino Acids (time frame: 0, 180 minutes following administration of the investigational product in crossover phase.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.