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1 Found 3 Abstracts CONTROL ID: TITLE: Fecal Microbiota Transplantation (FMT) for Treatment of Clostridium difficile Infection (CDI) in Immunocompromised Patients CONTACT (NAME ONLY): Colleen Kelly ABSTRACT STATUS: Sessioned AUTHORS/INSTITUTIONS: C. Ihunnah, C. Kelly, Gastroenterology, Brown Alpert Medical School, Providence, Rhode Island, UNITED STATES E. Hohmann, I. Youngster, Massachusetts General Hospital, Boston, Massachusetts, UNITED STATES M. Fischer, Indiana University School of Medicine, Indianapolis, Indiana, UNITED STATES J. Kao, University of Michigan, Ann Arbor, Michigan, UNITED STATES N. Singh, D. Suskind, Seattle Children's Hospital, Seattle, Washington, UNITED STATES O. Aroniadis, L.J. Brandt, Montefiore Medical Center, Bronx, New York, UNITED STATES M. Mellow, INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma, UNITED STATES A. Ray, Ochsner Clinic Foundation, New Orleans, Louisiana, UNITED STATES A. Barto, D.P. McQuillen, Lahey Clinic Medical Center, Burlington, Massachusetts, UNITED STATES A. Khoruts, K. Rank, University of Minnesota, Minneapolis, Minnesota, UNITED STATES A. Giovanelli, N. Stollman, Northern California Gastroenterology Consultants, Inc., Oakland, California, UNITED STATES S. Gordon, California Pacific Medical Center, San Francisco, California, UNITED STATES D. Kao, University of Alberta, Edmonton, Alberta, CANADA M. Schwartz, Virginia Mason Medical Center, Seattle, Washington, UNITED STATES T.J. Borody, Centre for Digestive Diseases, Sydney, New South Wales, AUSTRALIA A. Afzali, C. Surawicz, S. Vindigni, University of Washington School of Medicine, Seattle, Washington, UNITED STATES ABSTRACT BODY: Purpose: Patients who are immunocompromised (IC) are at increased risk of CDI, which has increased to epidemic proportions over the past decade. FMT appears effective for the treatment of CDI, though there is concern that IC patients may be at increased risk of having adverse events (AE) related to FMT. In this multicenter study, we aimed to describe rates of CDI cure after FMT as well as AE experienced by IC patients after FMT. Methods: A multicenter retrospective series was performed of the use of FMT in IC patients with CDI that was recurrent, refractory, or severe. A 32-item questionnaire soliciting demographic and pre- and post-fmt data was completed at 16 centers for 83 patients, of which 66 were eligible based on at least 12 weeks of post-fmt follow up. Outcomes included: (1) rates of CDI cure after FMT, (2) serious adverse events (SAE) such as death or hospitalization within 12 weeks of FMT, (3) infection within 12 weeks of FMT, and (4) AE related and unrelated to FMT. Results: Cases included adult (61) and pediatric (5) patients treated with FMT for refractory (12%), recurrent (54%), and overlap of recurrent/refractory and severe CDI (34%). Seventy eight percent were outpatients at time of FMT. The mean follow-up period between FMT and data collection was 12 months (range: 3-51 months). Reasons for IC included: HIV/AIDS (2), solid organ transplant (14), oncologic conditions (6), immunosuppressive therapy for IBD (32), and other IC due to medical condition/medication (12). The CDI cure rate after a single FMT was 78%, with 52 patients experiencing no recurrence at least 12 weeks post-fmt. Nine patients underwent repeat FMT, of which seven had no further CDI. Thus, the overall cure rate was 89%. Ten (15%) patients had a SAE within 12 weeks post- FMT, of which eight were hospitalizations. Two deaths occurred within 12 weeks of FMT, one of which was the result of aspiration during sedation for FMT administered via colonoscopy; the other was unrelated to FMT. None suffered infections definitely related to FMT, but one patient developed unrelated infection and two had self-limited diarrheal illness, which were probably unrelated, and for which no causal organism was identified. Three IBD patients (9%) experienced disease flare post-fmt. Two ulcerative colitis (UC) patients underwent colectomy related to course of UC >100 days after FMT. One patient had a superficial mucosal tear caused by the FMT colonoscopy and four patients reported mild, self limited abdominal discomfort post-fmt. Conclusion: This series demonstrates effective use of FMT for CDI in IC patients with few SAE or related AE. Importantly, there were no infectious complications in these high-risk patients. Further prospective studies of FMT in IC patients are needed to confirm safety and efficacy in this population. (no table selected)

2 (No Image Selected) Video Submission Confirmation: No Video Upload: Abstract Author: Investigator Commercial Products or Services: No Designed Study: Investigator FDA Approval: No Financial Relationships: Yes Extra Info: : Dr. Khoruts-Research Support: CIPAC, Ltd Dr. Brandt-Speaker's Bureau/Research Support: Optimer Pharmaceuticals, Inc. Dr. Gordon-Speaker: Cubist Initiated Research: Investigator Investigator Contribution: Yes Performed Analysis: Investigator Secondary Analyses: Not Applicable Study Results: Yes Submit: Supported by Industry Grant: No

3 CONTROL ID: TITLE: Follow-up Study of Fecal Microbiota Transplantation (FMT) for the Treatment of Refractory Irritable Bowel Syndrome (IBS) CONTACT (NAME ONLY): David Pinn ABSTRACT STATUS: Sessioned AUTHORS/INSTITUTIONS: D. Pinn, O. Aroniadis, L.J. Brandt, Montefiore Medical Center, Bronx, New York, UNITED STATES ABSTRACT BODY: Purpose: The etiology of IBS is multifactorial, with intestinal microbiota being increasingly implicated in its pathogenesis. FMT restores fecal microbiome diversity in patients with refractory C. difficile infection, and has impressive cure rates. We postulated FMT treatment of refractory IBS might result in similar benefit. Methods: A follow-up study was conducted of all patients who had FMT for refractory IBS after interventions of dietary modification, probiotics, antibiotics, and/or anti-depressants had failed. A 41-point questionnaire assessed demographic and pre- and post-fmt data, quantifying severity of abdominal pain, bloating, flatus, and dyspepsia (severe=3, moderate=2, mild=1, none=0); diarrhea (nl=0, 1-2 BM/day>nl= 1, 3-4 BM/day>nl=2, >4 BM/day>nl= 3), constipation (nl=0, >4BM/wk=1, 2-3BM/wk=2, <2BM/wk=3), and global well-being (poor=3, acceptable=2, good=1). Results: Thirteen of 15 eligible patients (54% women) completed the study. Average age was 45 years (range: years). Patients had IBS for an average of 73 months before FMT (range: months). Average time from FMT to data collection was 11 months (range: 6-18 months). Nine patients (64%) had IBS-D, three (21%) had IBS-C and one had IBS-M. Eleven patients (79%) had FMT once, one patient twice, and one patient three times. Eleven patients (79%) had abdominal pain before FMT (mean score: 2.55); after FMT, resolution, improvement, or no change was reported in three (27%), five (46%), and three (27%) patients, respectively (mean score: 1.45). Twelve patients (80%) complained of bloating before FMT (mean score: 2.25), which resolved, improved, or did not change in two (17%), four (33%), and six (50%) patients, respectively (mean score: 1.42). Before FMT, 12 patients (92%) had flatus (mean score: 2.4), and after FMT, resolution, improvement, no change, or worsening of flatus was reported in one (8%), four (33%), six (50%), and one (8%) patient, respectively (mean score: 1.75). Six patients (43%) had dyspepsia before FMT (mean score: 1.83) and two patients (33.3%) reported resolution, two (33.3%) noted improvement, and two (33.3%) had no change after FMT (mean score: 1.17). In nine IBS-D patients, pre-fmt score was 1.89 and post-fmt mean score was Of the three patients with IBS-C, mean pre-fmt score was 1.33 and post-fmt mean score was One patient had IBS-M and had improved diarrhea and constipation after FMT. Three patients (23%) reported no improvement. Before FMT, global well-being was reported as good in zero patients, acceptable in four patients (30%), and poor in nine patients (69%) (mean score: 2.69). After FMT, global well-being was good in three patients (23%), acceptable in six (46%) and poor in four (30%) (mean score: 1.92). Conclusion: FMT resolved or improved symptoms in 70% of our patients with refractory IBS, including abdominal pain (72%), bowel habit (69%), dyspepsia (67%), bloating (50%), and flatus (42%). FMT also resulted in improved quality of life (46%). (no table selected) (No Image Selected) Video Submission Confirmation: No Video Upload: Abstract Author: Investigator Commercial Products or Services: No Designed Study: Investigator FDA Approval: No Financial Relationships: No Initiated Research: Investigator Investigator Contribution: Yes Performed Analysis: Investigator Secondary Analyses: Not Applicable Study Results: Yes

4 Submit: Supported by Industry Grant: No

5 CONTROL ID: TITLE: Outcomes from Fecal Microbiota Transplantation in Adults with C. difficile Infection and Inflammatory Bowel Disease CONTACT (NAME ONLY): Sahil Khanna ABSTRACT STATUS: Sessioned AUTHORS/INSTITUTIONS: S. Khanna, P.C. Kashyap, J.F. Rainey, P.P. Kammer, E.V. Loftus, D.S. Pardi, Division of Gastoenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, UNITED STATES ABSTRACT BODY: Purpose: Inflammatory bowel disease (IBD) patients often get C. difficile infection (CDI), which is associated with poor outcomes. Fecal microbiota transplantation (FMT) is a reasonable option for recurrent CDI, but the data is controversial regarding the utility of FMT for management of IBD. Aim: To study outcomes from FMT in adults with concomitant CDI and IBD. Methods: Adult patients with IBD and recurrent or non-resolving CDI who had failed oral treatment for CDI were enrolled in the FMT program. Donors and recipients were screened using a standard protocol, and antibiotic treatment for CDI was stopped 24 hours prior to FMT. Concurrent treatment for IBD, including immunomodulators, biologics, and corticosteroids, were continued according to prior dosing schedules. After screening, 50 grams of donor stool was mixed with 250 ml of non-bacteriostatic saline to make a slurry that was filtered, placed on ice, and used within 6 hours. FMT was performed by colonoscopy with donor stool infused into the cecum. Outcomes after FMT were assessed by patient symptoms and stool tests if no resolution of symptoms was seen. Results: Thirteen patients were identified (seven Crohn s, six ulcerative colitis; eight males) with a median age of 27 years (range, 21-48) and median IBD duration of 3 years (range, ). They had a median four CDI episodes (range, 1-12) and a median of five (range, 2-13) failed CDI therapy regimens, with 77% (n=10) failing two or more different drugs, and 77% (n=10) patients failing at least one prolonged vancomycin taper. Six patients were on 5-ASA agents, six on biologics, three on immunomodulators, five on steroids. Post-FMT, 92% (n=12) noted some improvement in their symptoms and over all well-being, one had no improvement in diarrhea, tested positive for CDI, and was treated with fidaxomicin. Of the 12 with symptomatic improvement, six patients had complete resolution, and six had partial improvement. Of these six with some residual diarrhea, five tested negative for CDI, and one was empirically treated with metronidazole at home without testing for CDI with no improvement. Therefore, overall 85% (n=11) of patients had resolution of CDI either by symptom resolution or by laboratory testing. The median time to resolution in patients with complete symptom resolution was 2 days (range, 1-14). No patient was able to decrease or discontinue IBD therapy after FMT. In fact, 46% needed escalation of their IBD therapy after clearance of CDI. There were no adverse events noted with FMT in these patients. Conclusion: FMT appears to be a safe and effective mode of treatment of recurrent CDI in patients with IBD, and leads to resolution of CDI in most patients. However, FMT does not appear to improve the course of IBD in most patients. (no table selected) (No Image Selected) Video Submission Confirmation: No Video Upload: Abstract Author: Investigator Commercial Products or Services: No Designed Study: Investigator FDA Approval: No Financial Relationships: No Initiated Research: Investigator Investigator Contribution: Yes

6 Performed Analysis: Investigator Secondary Analyses: Not Applicable Study Results: Yes Submit: Supported by Industry Grant: No