Crohn's Disease Clinical Trial
Official title:
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.
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