AGA Abstracts * normal lab range for C-reactive protein is ≤ 0.8. Su1402 Short and Long Term Outcomes of Severe Ulcerative Colitis Patients Treated With Tacrolimus and Infliximab Naoki Minami, Takuya Yoshino, Minoru Matsuura, Hiroshi Nakase [Background&Aim] The therapeutic strategy of severe ulcerative colitis (UC) is challenging. There are a few studies evaluating the efficacy of tacrolimus (TAC) or infliximab (IFX) in severe UC patients. In current situation, the safety and efficacy of the sequential approaches (TAC→IFX / IFX→TAC) in severe UC patients remain unknown. The aim of this study was to assess short and long term outcomes of severe UC patients treated with TAC and IFX. [Methods] From October 2001 to October 2013, consecutive 29 severe UC patients treated with TAC or IFX were retrospectively enrolled (mean follow up 27 months). Clinical remission was defined as modified Truelove Witts severity index (MTWSI) of less than 5. Clinical response was defined as a decrease of MTWSI of at least 4 points from baseline. TAC was administered orally at the initial dose of 0.1 mg/kg per day and was adjusted to produce whole-blood trough levels of 10 to 15 ng/mL. IFX was administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks as induction therapy and every 8 weeks as maintenance therapy. The primary endpoint of this study was short-term response at 8 weeks after induction of TAC or IFX. Secondary endpoints included colectomy-free survival and treat- ment safety. Cumulative colectomy free survival was assessed using the Kaplan-Meir method. A univariate analysis was performed to detect the predictive valuables related to colectomy. [Results] Of the 29 patients, 22 and 7 patients were firstly treated with TAC (TAC group) and with IFX (IFX group), respectively. Induction of remission ratio at 8weeks in TAC and IFX group were 64% and 57%, respectively. No significant difference of induction of remission was observed between two groups. During this observational study, in TAC group, 11 patients (50%) kept clinical remission by TAC or thiopurines and 6 patients (27%) required IFX (TAC→IFX) for maintaining clinical remission. In IFX group, 3 patients (43%) kept clinical remission by IFX and 3 patients (43%) required TAC (IFX→TAC) for maintaining clinical remission. Of the 29 patients, 6 patients (21%) required colectomy, and 5 of them did not respond to the sequential approaches. Cumulative colectomy free survival rate was 79.3 % at 118 months. The positivity of CMV-DNA in colonic mucosa was a significant predictor in colectomy. The initial treatment (TAC or IFX), gender, age, extent of disease, MTWSI and endoscopic Mayo score were not predictors in colectomy. No severe adverse event was observed during this observational study. [Conclusion] Our data suggested that treatment with TAC and IFX, and the sequential approaches (TAC→IFX or IFX→TAC) made it possible to avoid colectomy in severe UC patients, although greater consideration should be given to the serious infection. Su1403 Single Colonoscopically Administered Fecal Microbiota Transplant for Ulcerative Colitis-A Pilot Study to Determine Therapeutic Benefit and Graft Stability Christopher Damman, Mitchell Brittnacher, Hillary Hayden, Matthew Radey, Kyle Hager, Samuel Miller, Timothy L. Zisman Background: Fecal microbiota therapy (FMT) is an emerging treatment for gastrointestinal disorders marked by dysbiosis. Ulcerative colitis (UC) is an inflammatory disorder of the colonic mucosa in which the microbiota has been shown to be dysbiotic. The extent to which dysbiosis is the result or the cause of the disease remains unclear, although evidence supports the therapeutic effect of exogenous microbes in the form of probiotics. FMT as a nature-tailored probiotic may contain necessary microbes for reestablishing eubiosis and treating UC. Methods: 5 Clostridium difficile negative subjects with mildly to moderately active ulcerative colitis were treated with a single colonoscopically administered fecal microbiota transplant without antibiotic pretreatment and after a GoLYTELY bowel purge. The transplant consisted of a normal saline stool mixture derived from a family member or friend. Donor stool was extensively screened for potential pathogens. Rectal biopsies were obtained before and after transplant. Stool samples from the recipient were obtained before and after transplant and analyzed using metagenomic sequencing. Results: One out of 5 patients treated with a single colonoscopic fecal transplant went into clinical remission by ulcerative colitis disease activity index (UCDAI) score and histological score at one month after transplant. Three out of the remaining 5 patients had improvement in their histological score one month after transplant. One out of 5 patients had a worsened histology and UCDAI score at one month after transplant. (Figure 1) The degree to which the donor stool engrafted on a global level one month after transplant did not correlate with the degree of clinical improvement. (Figure 2) Conclusions: Fecal microbiota therapy for ulcerative colitis may lead to histological improvement and/or remission in a subset of patients. FMT may lead to a new microbial-based therapeutic paradigm for UC. Further work is needed to S-460 AGA Abstracts identify taxonic subsets of the microbiota that may correlate positively and negatively with FMT efficacy. Further work is also necessary to identify appropriate FMT recipients and develop an optimal FMT protocol. Su1404 Intravenous Cyclophosphamide Combined With Thalidomide Has a Promising Effect in Refractory Crohn's Disease Jian Tang, Xiang Gao, Min Zhi, Huimin Zhou, Huangwei Chen, Min Zhang, Qingfan Yang, Zhezhao Liang Background In refractory Crohn's disease, established therapies fail in a relevant proportion of patients. In recent studies, both intravenous cyclophosphamide and thalidomide showed efficacy in these patients. Aim To provide clinical and endoscopic evidence for the rationale to apply intravenous cyclophosphamide combined with thalidomide therapy as therapeutic option in refractory Crohn's disease Methods Fifteen patients with refractory Crohn's disease participated in this prospective open-labelled uncontrolled pilot study. All patients were treated with intravenous cyclophosphamide (200mg qod×2 weeks followed by 400mg per week until reached a total dose of 6.0-8.0 g), and combined thalidomide(25-75mg per day based on the tolerance of patients) for 3-4months. Results Nine of 15 patients were steroid- refractory and the others were steroid-dependent. Four patients were ineffective to infliximab therapy. Ten of 15 patients (67%) achieved remission within 2 weeks after cyclophosphamide and thalidomide therapy, with a Crohn's Disease Activity Index (CDAI) declined from 238 to 135 (median). At week 10 after initiation therapy, the clinical remission rate was 86%(12/ 14). When finished a total dose of 6.0-8.0 g cyclophosphamide, twelve of 14 patients had endoscopic improvement with Simple Endoscopic Score for Crohn's Disease (SESCD) declined from 9.4 to 4.7 (median). Among them four patients reached muscle healing. 33%(5/ 15) patients suffered adverse event. Three had mild increase in aminotransferases(range:62- 144,median: 82) and one had leukemia. Only one patient quit the treatment because of serious urinary infection at week 2 after initiating cyclophosphamide therapy. Conclusions In refractory Crohn's disease, intravenous cyclophosphamide combined with oral thalidomide may be a promising therapeutic option for not only clinical remission inducing but endoscopic improvement. Adverse events of this regime are not rare and should be monitored carefully. Figure 1 A:CDAI after initiation intravenous cyclophosphamide and oral thalidomide therapy (n=15). B:SESCD after initiation intravenous cyclophosphamide and oral thalidomide therapy (n=14)