To Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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,
  • 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®