HIV-associated EnteropathyNCT01828593
Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
A study testing Serum-derived bovine immunoglobulin protein isolate (SBI) in people with HIV-associated Enteropathy, run by Entera Health, Inc at 10 sites in United States.
Trial summary
The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-associated Enteropathy
- 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
- 103 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2013to Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of HIV-1 infection
- Plasma HIV viral load ≤40 copies/mL
- Maintained virologic suppression for 1 year
- Stable Antiretroviral Therapy (ART) regimen
- History of HIV-associated diarrhea defined as abnormal passage of 3 or more unformed stools per day or a liquid stool volume greater than 200 g per day for at least 4 weeks duration
Who cannot join
- Positive stool test for pathogenic bacteria, C. difficile or ova and parasites
- Conditions that require chronic therapy that is known to alter gut microbiota
- Antibiotics within 2 weeks of screening (exception: prophylaxis antibiotics)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Boston, Massachusetts, 02461
Study site
Chicago, Illinois, 600654
Study site
Cincinnati, Ohio, 45206
Study site
Detroit, Michigan, 48201
Therafirst
Fort Lauderdale, Florida, 33308
Study site
Fort Worth, Texas, 76107
AIDS Research Alliance
Los Angeles, California, 90015
Study site
Miami Springs, Florida, 33166
Univ of California Davis CARES Clinic
Sacramento, California, 95817
Univ of California SF
San Francisco, California, 94110
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Study Evaluating the Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in HIV+ Subjects With HIV-associated Enteropathy.
The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.
Read the detailed description
This study is evaluating the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5g BID and SBI 5.0g compared to placebo for 6 months on gastrointestinal symptoms, nutritional status and quality of life in HIV+ subjects with HIV-associated enteropathy. In addition, the effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation will be investigated.
- Conditions
- HIV-associated Enteropathy
- Being tested
- Serum-derived bovine immunoglobulin protein isolate (SBI), Placebo
- Medical subject headings
- HIV Enteropathy
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
SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching Placebo Receives: Other: Placebo |
| SBI 2.5 g | Active comparator | Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g Receives: Other: Serum-derived bovine immunoglobulin protein isolate (SBI) |
| SBI 5.0g | Active comparator | Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g Receives: Other: Serum-derived bovine immunoglobulin protein isolate (SBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Daily Unformed Bowel Movements
Change in number of abnormal or unformed stools by week 4
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionSep 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 HIV-associated EnteropathyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entera Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David M Asmuth, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828593
- Sponsor's protocol ID
- EH6001
- Status last verified
- Apr 2017
- First submitted
- 8 Apr 2013
- Last updated
- 21 Jun 2017
- 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 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Study Evaluating the Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in HIV+ Subjects With HIV-associated Enteropathy.
- ClinicalTrials.gov ID
- NCT01828593
- Acronym / sponsor ID
- EH6001
- Conditions
- HIV-associated Enteropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Entera Health, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Posted 8 Mar 2016
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 the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.
Detailed description
This study is evaluating the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5g BID and SBI 5.0g compared to placebo for 6 months on gastrointestinal symptoms, nutritional status and quality of life in HIV+ subjects with HIV-associated enteropathy. In addition, the effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation will be investigated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboMatching Placebo |
| SBI 2.5 g | Active comparator | Other: Serum-derived bovine immunoglobulin protein isolate (SBI)Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g |
| SBI 5.0g | Active comparator | Other: Serum-derived bovine immunoglobulin protein isolate (SBI)Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of HIV-1 infection
- Plasma HIV viral load ≤40 copies/mL
- Maintained virologic suppression for 1 year
- Stable Antiretroviral Therapy (ART) regimen
- History of HIV-associated diarrhea defined as abnormal passage of 3 or more unformed stools per day or a liquid stool volume greater than 200 g per day for at least 4 weeks duration
Key exclusion criteria (3 listed)
- Positive stool test for pathogenic bacteria, C. difficile or ova and parasites
- Conditions that require chronic therapy that is known to alter gut microbiota
- Antibiotics within 2 weeks of screening (exception: prophylaxis antibiotics)
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)SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. | Other | SBI 2.5 g, SBI 5.0g |
| PlaceboMatching placebo | Other | Placebo |
Primary outcome
Frequency of Daily Unformed Bowel Movements
Time frame: Baseline and 4 weeks
Change in number of abnormal or unformed stools by week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David M Asmuth, M.D. principal investigator
University of California, Davis
10 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 HIV-associated Enteropathy, run by Entera Health, Inc at 10 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 5 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 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. 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 8 Mar 2016). 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?
Frequency of Daily Unformed Bowel Movements (time frame: Baseline and 4 weeks). 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 21 Jun 2017.