To Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease
- Conditions
- Crohn's Disease
- Interventions
- Other: PlaceboOther: Serum-derived Bovine Immunoglobulin / Protein Isolate
- Registration Number
- NCT02649075
- Lead Sponsor
- Entera Health, Inc
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
- 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.
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Positive stool test for pathogenic bacteria including Clostridium difficile or O&P.
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Confirmed intestinal stricture with obstructive-like clinical symptoms.
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Bowel resection within the previous 6 months.
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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.
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Taking greater than 20 mg per day of a corticosteroid (prednisone or prednisolone) or greater than 9 mg of budesonide.
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Received biologic therapy in past 2 years.
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Diagnosis of one or more co-morbid condition (s) requiring medical or surgical therapy that may affect bowel function, gastrointestinal symptoms.
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Serious infection in the 3 months prior to enrollment.
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Allergy or intolerance to beef or to any ingredient used in the product.
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Participated in an investigational drug or device study within 30 days.
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Does not have access to the internet.
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Taken EnteraGam®
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo BID Placebo Placebo w/control protein SBI 10 g BID Serum-derived Bovine Immunoglobulin / Protein Isolate Serum-derived Bovine Immunoglobulin / Protein Isolate (SBI) 10.0 grams twice per day
- Primary Outcome Measures
Name Time Method Change in abdominal pain intensity score 12 weeks Change in fecal calprotectin 12 weeks Change in Crohn's Disease Activity Index (CDAI) 12 weeks Change in plasma albumin levels 12 weeks Change in body mass index 12 weeks Change in the number of liquid and soft stools 12 weeks Change in C-reactive protein (CRP) 12 weeks Change in Quality of Life (SF-36) 12 weeks Change in weight 12 weeks
- Secondary Outcome Measures
Name Time Method Measure clinically significant changes from baseline in vital signs 12 and 24 weeks Clinically significant changes from baseline in laboratory testing 12 and 24 weeks Assess the incidence of adverse events (AEs) and serious AEs (SAEs) 12 and 24 weeks
Trial Locations
- Locations (6)
North Little Rock
🇺🇸North Little Rock, Arkansas, United States
Manhattan
🇺🇸New York, New York, United States
Hollywood
🇺🇸Hollywood, Florida, United States
Hagerstown
🇺🇸Hagerstown, Maryland, United States
Winter Park
🇺🇸Winter Park, Florida, United States
Cincinnati
🇺🇸Cincinnati, Ohio, United States