title: Management of inflammatory bowel disease with oral serum-derived bovine immunoglobulin.
abstract: BACKGROUND
  The clinical effect of oral serum-derived bovine immunoglobulin/protein isolate (SBI) on symptom and disease management in patients with inflammatory bowel disease (IBD) is reported in this retrospective case series.
  
  
  METHODS
  A single-center, retrospective chart review of IBD patients [N = 45; Crohn's disease (CD), n = 38 and ulcerative colitis (UC), n = 7] with limited to no response to traditional pharmaceutical therapies in controlling symptoms was performed after providing SBI (5 g/day) for nutritional support. Patients were contacted at least monthly to assess response to SBI for symptom management measured by a Likert scale (0 = none; 1 = minimal; 2 = moderate; 3 = significant; 4 = complete). Analysis of variance (ANOVA) was performed on response to therapy based on patient characteristics (age, gender, race) and IBD diagnosis. A multivariate ordered logistical regression model was performed to determine the odds ratio in overall disease management between week 1 and week 12. Finally, the overall group response and percent improvement to SBI was determined over 12 weeks.
  
  
  RESULTS
  The odds ratio from the regression model demonstrated that IBD patients were 2.8 times more likely to report clinical improvement in symptom scores with the addition of SBI to their therapeutic regimens [95% confidence interval (CI) 1.266-6.016, p = 0.011]. Disease management was not significantly associated with age, gender, race or disease state. The percentage of patients reporting a response to SBI therapy at week 1 was 49% which increased to 76% after 12 weeks with the fraction of responders gaining significant symptom improvement doubling during the same time period (9% versus 20%). Overall, this group of IBD patients showed increased, steady response to SBI therapy between week 1 and 12 with no reported side effects.
  
  
  CONCLUSIONS
  These results suggest that SBI improves clinical management of IBD patients who are not fully managed on traditional therapies. SBI should be considered for the nutritional support of IBD regardless of disease activity, location, phenotype, duration, or complexity.
authors.affiliation: University of Central Florida Medical School, Orlando, FL, USA.
authors.forename: Ira
authors.initials: I
authors.lastname: Shafran
authors.affiliation: Shafran Gastroenterology Center, Winter Park, FL, USA.
authors.forename: Patricia
authors.initials: P
authors.lastname: Burgunder
authors.affiliation: WC, LLC, Cary, NC, USA.
authors.forename: David
authors.initials: D
authors.lastname: Wei
authors.affiliation: Entera Health, Inc., Cary, NC, USA.
authors.forename: Hayley E
authors.initials: HE
authors.lastname: Young
authors.affiliation: Entera Health, Inc., Cary, NC, USA.
authors.forename: Gerald
authors.initials: G
authors.lastname: Klein
authors.affiliation: Entera Health, Inc., 2000 Regency Parkway, Suite 255, Cary, NC 27518, USA.
authors.forename: Bruce P
authors.initials: BP
authors.lastname: Burnett
keywords: Crohn’s disease; inflammatory bowel disease; oral immunoglobulin; serum-derived bovine immunoglobulin/protein isolate; ulcerative colitis