To Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease
NCT ID: NCT02649075
Last Updated: 2017-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2016-02-29
2017-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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SBI 10 g BID
Serum-derived Bovine Immunoglobulin / Protein Isolate (SBI) 10.0 grams twice per day
Serum-derived Bovine Immunoglobulin / Protein Isolate
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.
Placebo BID
Placebo w/control protein
Placebo
Matching placebo with control hydrolyzed gelatin protein. Two packets BID.
Interventions
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Serum-derived Bovine Immunoglobulin / Protein Isolate
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.
Placebo
Matching placebo with control hydrolyzed gelatin protein. Two packets BID.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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,
* 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®
18 Years
ALL
No
Sponsors
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Entera Health, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Audrey L Shaw, PhD
Role: STUDY_DIRECTOR
Entera Health, Inc
Locations
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North Little Rock
North Little Rock, Arkansas, United States
Hollywood
Hollywood, Florida, United States
Winter Park
Winter Park, Florida, United States
Hagerstown
Hagerstown, Maryland, United States
Manhattan
New York, New York, United States
Manhattan
New York, New York, United States
Cincinnati
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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EH6112
Identifier Type: -
Identifier Source: org_study_id