Retrospective Chart Review Study of Patients Receiving Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) for Nutritional Management of Irritable Bowel Syndrome with Diarrhea (IBS-D)

Abstract

Introduction: IBS-D is a common condition with few effective treatment options. The prescription medical food, SBI, has been shown to manage chronic loose and frequent stools in IBS-D patients. The safety and effectiveness of SBI as a therapy for IBS-D was further examined in this multi-center, IRB-reviewed study for overall and individual symptom response. Methods: Symptom data including stool frequency and consistency (Bristol Stool Scale 1-7), abdominal pain intensity (0 = no pain to 10 = worst pain) and adverse events (AEs) were collected from medical charts on 116 patients. Criteria for inclusion in primary analysis were patients having baseline recorded scores for stool consistency and abdominal pain, failure of standard-of-care (SOC) treatment, and not having received confounding IBS-D medications while on SBI. Results: The majority of patients who met criteria for analysis (n = 34) were white (94%), female (71%) with a median age of 53 (28, 85) and received SBI therapy for a mean duration of 23.2±24.1 wks [median 15.5 wks (0.4, 97.9)]. Mean baseline symptom scores were: stool frequency 5.24 (range 2 to 20); stool consistency 6.00 (range 4 to 7) and abdominal pain 4.56 (range 2 to 10). Twenty-five of the 34 patients had baseline abdominal pain scores >2 and stool consistency scores ≥ 5 to assess overall response; nine patients were excluded based on absence of pain (recorded score = 0) and normal stool score (Bristol Stool Scale = 4) at baseline. Of the 25 patients, 16 (64%) were responders with stool consistency < 5 and a 30% reduction in abdominal pain scores following SBI therapy. Using a generalized linear regression model for individual symptoms, the number of stools per day decreased by 3.24 (95% Confidence Interval (CI) 0.50, 5.98; P = 0.022), stool consistency improved by 1.86 (95% CI, 1.39, 2.33; P < 0.0001) and abdominal pain/discomfort intensity decreased by 3.03 (95% CI 1.668, 4.39; P < 0.0001). Thirteen of the 116 patients experienced one or more AEs while on SBI therapy. The main AEs were nausea (n = 5 patients) and an increase abdominal discomfort (n = 2 patients). No serious AEs were reported. Conclusion: Though retrospective, the inclusion criteria of SOC failure prior to SBI administration with demonstrated high combined abdominal pain and stool consistency response, as well as statistically significant individual symptom improvement, demonstrate SBI's clinical utility in IBS-D management. Additional chart reviews continue.