Clinical Trial: Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With IPAA

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: Evaluating the Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Ileal Pouch-Anal Anastomosis

Brief Summary: This is an open label trail to test the hypothesize that serum bovine immunoglobulin protein isolate (SBI) will improve the nutritional status and quality of life (QOL) of patients with an ileal pouch anal anastomosis (IPAA) and symptoms of pouchitis. Subjects with symptomatic IPAA will receive two packets of EnteraGam twice daily (total daily dose of 20 g SBI) for up to 24 weeks. The primary objective of this study is to determine whether SBI therapy leads to improved nutritional status and QOL. A secondary objective is to evaluate SBI in the management of their disease, including impact on clinical symptoms.