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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Other: Serum-derived Bovine Immunoglobulin / Protein Isolate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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®

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SBI 10 g BID<br>Serum-derived Bovine Immunoglobulin / Protein Isolate (SBI) 10.0 grams twice per day | Other: Serum-derived Bovine Immunoglobulin / Protein Isolate<br>* 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.<br>* Other names: EnteraGam;|
| Placebo Comparator: Placebo BID<br>Placebo w/control protein | Other: Placebo<br>* Matching placebo with control hydrolyzed gelatin protein. Two packets BID.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of liquid and soft stools |  | 12 weeks | 
| Change in abdominal pain intensity score |  | 12 weeks | 
| Change in fecal calprotectin |  | 12 weeks | 
| Change in C-reactive protein (CRP) |  | 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 weight |  | 12 weeks | 
| Change in Quality of Life (SF-36) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the incidence of adverse events (AEs) and serious AEs (SAEs) |  | 12 and 24 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, Inflammatory Bowel Disease, Crohn's, Crohns, SBI, Serum-derived bovine immunoglobulin / protein isolate, EnteraGam