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P-003 Remission of Pouchitis in Patients Following Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) Therapy

Background:Total proctocolectomy with ileo-anal anastomosis (commonly known as a J-pouch) is the preferred surgical intervention for refractory or fulminant ulcerative colitis. Although there is high patient satisfaction with this treatment, a substantial incidence of pouchitis is reported in approximately 30% to 60% of patients followed for more than 1 year. The cause of pouchitis is unknown, but may result from toxins liberated during bacterial degradation, changes in intraluminal pH, shifts in microbiome, or yet to be determined factors. Patients with pouchitis frequently present with bloody diarrhea, urgency, and dehydration as well as endoscopic evidence of erythema of the mucosal pouch. While there is no FDA approved treatment for pouchitis, most conventional treatments are unsatisfactory and include the use of antibiotics, systemic and topical steroids, budesonide, topical mesalamine, and VERSUSL#3. Serum-derived bovine immunoglobulin/protein isolate (SBI) has a multifaceted mechanism of action to help maintain and support barrier function within the gastrointestinal tract including binding to microbial components (i.e., bacterial toxins) which may result in the reduction of downstream inflammatory markers and tight junction restoration. This prescription medical food has been shown to help manage chronic loose and frequent stools in patients with IBS-D and with sustained use, help patients with refractory IBD achieve normalized bowel function. As such, SBI was considered as an additional therapeutic option for these refractory pouchitis patients. Methods:A retrospective chart review of 10 pouchitis patients, ages 24 to 69 years, who failed to adequately respond to conventional therapy were reviewed to determine their response to the addition of SBI in the management of their pouchitis and the potential to achieve remission. Results:For these 10 patients, conventional therapies of ciprofloxacin, budesonide and/or other typical measures failed to achieve remission. It was not until the addition of SBI (5 g QD or BID) that 9 of 10 patients achieved clinical, asymptomatic remission of their pouchitis with endoscopic remission documented in 2 of these patients. In general, pouchitis symptom improvements were noted within 2 to 3 weeks of therapy initiation. Maintenance therapy of SBI (5 g QD or BID) has allowed 8 of 10 patients to continue remission for more than 1 year while another patient has been in remission for nearly 9 months. Additionally, the use of SBI has allowed 7 of 10 patients to eliminate the need of some or all other therapies (antibiotics, steroids, or others) as part of the ongoing management of their pouchitis. Only a single patient had not experienced remission as a biopsy revealed mild distal mucosal erythema with mild-moderate histologic evidence of inflammation. Despite the lack of remission, the patient did experience improvement in stool frequency. Conclusions:For pouchitis patients, refractory to conventional therapy, the addition of SBI may provide capacity to bind microbial components, a potential trigger of inflammatory flares, thus allowing the patient to achieve remission. A comprehensive study would be useful to demonstrate if SBI as part of a therapeutic approach for pouchitis would help facilitate and maintain remission as well as achieve an earlier response to pouchitis flares in these patients.