Crohn's DiseaseNCT02649075
To Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease
A study testing Serum-derived Bovine Immunoglobulin / Protein Isolate in people with Crohn's Disease, run by Entera Health, Inc at 7 sites in United States.
Trial summary
The objective of this study is to evaluate the nutritional therapy with SBI (a medical food) as compared to placebo in the clinical dietary management of mild to moderate Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Serum-derived Bovine Immunoglobulin / Protein Isolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Confirmed diagnosis of mild to moderate Crohn's disease for at least 3 months.
- Screening CDAI between >150 and ≤ 250 based on subject recall.
- Average of greater than two liquid or soft stools per day and an abdominal pain intensity score >1.
- Subject has at least one positive biomarker of inflammation: fecal calprotectin >100 µg/g; elevated C-reactive protein (CRP) >2 mg/dL.
Who cannot join
- Positive stool test for pathogenic bacteria including Clostridium difficile or O\&P.
- Confirmed intestinal stricture with obstructive-like clinical symptoms.
- Bowel resection within the previous 6 months.
- Change in medical therapy: must have been on a stable dose of
- corticosteroids (prednisone or prednisolone) less than or equal to 20 mg per day for 2 weeks prior to screening,
- budesonide less than or equal to 9 mg per day for 2 weeks prior to screening,
Show all 16Show fewer
- 5-aminosalicylates for 2 weeks prior to screening, and
- immunomodulators for 6 weeks prior to screening.
- Taking greater than 20 mg per day of a corticosteroid (prednisone or prednisolone) or greater than 9 mg of budesonide.
- Received biologic therapy in past 2 years.
- Diagnosis of one or more co-morbid condition (s) requiring medical or surgical therapy that may affect bowel function, gastrointestinal symptoms.
- Serious infection in the 3 months prior to enrollment.
- Allergy or intolerance to beef or to any ingredient used in the product.
- Participated in an investigational drug or device study within 30 days.
- Does not have access to the internet.
- Taken EnteraGam®
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cincinnati
Cincinnati, Ohio, 45219
Hagerstown
Hagerstown, Maryland, 21742
Hollywood
Hollywood, Florida, 30021
Manhattan
New York, New York, 10021
Manhattan
New York, New York, 10028
North Little Rock
North Little Rock, Arkansas, 72117
Winter Park
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Pilot Study Evaluating Serum-Derived Bovine Immunoglobulin / Protein Isolate in the Dietary Management of Mild to Moderate Crohn's Disease
The objective of this study is to evaluate the nutritional therapy with SBI (a medical food) as compared to placebo in the clinical dietary management of mild to moderate Crohn's disease.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multi-center, pilot study evaluating SBI 10 g BID compared to matching placebo for 12 weeks followed by a 12 week open-label extension SBI 10 g BID (EnteraGam) in the dietary management of mild to moderate Crohn's disease.
The effect of SBI will be evaluated on Crohn's disease related symptoms and inflammation symptom control as measured by Crohn's disease activity index (CDAI) scores and plasma and stool markers of inflammation. The patient's quality of life will also be assessed as an indicator of disease state.
- Conditions
- Crohn's Disease
- Being tested
- Serum-derived Bovine Immunoglobulin / Protein Isolate, Placebo
- Keywords
- IBD, Inflammatory Bowel Disease, Crohn's, Crohns, SBI, Serum-derived bovine immunoglobulin / protein isolate, EnteraGam
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum-derived Bovine Immunoglobulin / Protein IsolateOther
Also called EnteraGam
Serum-derived bovine immunoglobulin protein isolate (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. Two packets (each packet contains 5 g of SBI) BID.
PlaceboOther
Matching placebo with control hydrolyzed gelatin protein. Two packets BID.
| Study group | Role | What they receive |
|---|---|---|
| SBI 10 g BID | Active comparator | Serum-derived Bovine Immunoglobulin / Protein Isolate (SBI) 10.0 grams twice per day Receives: Other: Serum-derived Bovine Immunoglobulin / Protein Isolate |
| Placebo BID | Placebo comparator | Placebo w/control protein Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of liquid and soft stools
Measured: 12 weeks
Change in abdominal pain intensity score
Measured: 12 weeks
Change in fecal calprotectin
Measured: 12 weeks
Change in C-reactive protein (CRP)
Measured: 12 weeks
Change in Crohn's Disease Activity Index (CDAI)
Measured: 12 weeks
Change in plasma albumin levels
Measured: 12 weeks
Change in body mass index
Measured: 12 weeks
Change in weight
Measured: 12 weeks
Change in Quality of Life (SF-36)
Measured: 12 weeks
Secondary outcomes (3)
Assess the incidence of adverse events (AEs) and serious AEs (SAEs)
Measured: 12 and 24 weeks
Measure clinically significant changes from baseline in vital signs
Measured: 12 and 24 weeks
Clinically significant changes from baseline in laboratory testing
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: Lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entera Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Audrey L Shaw, PhD, Study director, Entera Health, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649075
- Sponsor's protocol ID
- EH6112
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2015
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Pilot Study Evaluating Serum-Derived Bovine Immunoglobulin / Protein Isolate in the Dietary Management of Mild to Moderate Crohn's Disease
- ClinicalTrials.gov ID
- NCT02649075
- Acronym / sponsor ID
- EH6112
- Conditions
- Crohn's Disease
- Keywords
- IBD, Inflammatory Bowel Disease, Crohn's, Crohns, SBI, Serum-derived bovine immunoglobulin / protein isolate, EnteraGam
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Entera Health, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the nutritional therapy with SBI (a medical food) as compared to placebo in the clinical dietary management of mild to moderate Crohn's disease.
Detailed description
This is a randomized, double-blind, placebo-controlled, multi-center, pilot study evaluating SBI 10 g BID compared to matching placebo for 12 weeks followed by a 12 week open-label extension SBI 10 g BID (EnteraGam) in the dietary management of mild to moderate Crohn's disease.
The effect of SBI will be evaluated on Crohn's disease related symptoms and inflammation symptom control as measured by Crohn's disease activity index (CDAI) scores and plasma and stool markers of inflammation. The patient's quality of life will also be assessed as an indicator of disease state.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBI 10 g BID | Active comparator | Other: Serum-derived Bovine Immunoglobulin / Protein IsolateSerum-derived Bovine Immunoglobulin / Protein Isolate (SBI) 10.0 grams twice per day |
| Placebo BID | Placebo comparator | Other: PlaceboPlacebo w/control protein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of mild to moderate Crohn's disease for at least 3 months.
- Screening CDAI between >150 and ≤ 250 based on subject recall.
- Average of greater than two liquid or soft stools per day and an abdominal pain intensity score >1.
- Subject has at least one positive biomarker of inflammation: fecal calprotectin >100 µg/g; elevated C-reactive protein (CRP) >2 mg/dL.
Key exclusion criteria (16 listed)
- Positive stool test for pathogenic bacteria including Clostridium difficile or O\&P.
- Confirmed intestinal stricture with obstructive-like clinical symptoms.
- Bowel resection within the previous 6 months.
- Change in medical therapy: must have been on a stable dose of
- Taking greater than 20 mg per day of a corticosteroid (prednisone or prednisolone) or greater than 9 mg of budesonide.
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 IsolateAlso: EnteraGamSerum-derived bovine immunoglobulin protein isolate (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. Two packets (each packet contains 5 g of SBI) BID. | Other | SBI 10 g BID |
| PlaceboMatching placebo with control hydrolyzed gelatin protein. Two packets BID. | Other | Placebo BID |
Primary outcome
Change in the number of liquid and soft stools
Time frame: 12 weeks
Change in abdominal pain intensity score
Time frame: 12 weeks
Change in fecal calprotectin
Time frame: 12 weeks
Change in C-reactive protein (CRP)
Time frame: 12 weeks
Change in Crohn's Disease Activity Index (CDAI)
Time frame: 12 weeks
Change in plasma albumin levels
Time frame: 12 weeks
Change in body mass index
Time frame: 12 weeks
Change in weight
Time frame: 12 weeks
Change in Quality of Life (SF-36)
Time frame: 12 weeks
3 secondary outcomes
Assess the incidence of adverse events (AEs) and serious AEs (SAEs)
Time frame: 12 and 24 weeks
Measure clinically significant changes from baseline in vital signs
Time frame: 12 and 24 weeks
Clinically significant changes from baseline in laboratory testing
Time frame: 12 and 24 weeks
Results and safety
The study was stopped early (reason given: Lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
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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.
Audrey L Shaw, PhD study director
Entera Health, Inc
7 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 in people with Crohn's Disease, run by Entera Health, Inc at 7 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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was stopped early (reason given: Lack of enrollment.). Results are not available in the source record.
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?
Change in the number of liquid and soft stools (time frame: 12 weeks). The study lists 9 primary outcomes in all. 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 4 Oct 2017.