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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
7
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.
Matching placebo with control hydrolyzed gelatin protein. Two packets BID.
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
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
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
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Manhattan
New York, New York, United States
Manhattan
New York, New York, United States
Cincinnati
Cincinnati, Ohio, United States