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Background and Aims: To investigate the efficacy and safety of three different dosages of embryonated, viable eggs of Trichuris suis [TSO] versus placebo for induction of remission in mildly-to-moderately active ileocolonic, uncomplicated Crohn's disease [CD].Methods: Adults with active CD [n = 252] randomly received six fortnightly doses of 250, 2500, or 7500 TSO/15 ml suspension/day [TSO 250, TSO 2500, TSO 7500], or 15 ml placebo solution/day, in a double-blind fashion, with 4 weeks' follow-up. Primary endpoint was the rate of clinical remission [Crohn's Disease Activity Index [CDAI] < 150] at end of treatment, ie at Week 12 or withdrawal. Secondary endpoints included the course of clinical remission, rate of clinical response, change in CDAI, change in markers of inflammation, mucosal healing, and Physician's Global Assessment.Results: Clinical remission at Week 12 occurred in 38.5%, 35.2%, and 47.2% of TSO 250, TSO 2500, and TSO 7500 patients, respectively, and in 42.9% of placebo recipients. TSO induced a dose-dependent immunological response. There was no response regarding laboratory markers of inflammation. Other secondary efficacy variables also showed no advantage of TSO over placebo for treatment of active CD. Administration of TSO did not result in any serious adverse drug reaction. Review of non-serious suspected adverse drug reactions following TSO did not reveal any safety concerns.Conclusions: Administration of 250-7500 TSO fortnightly over 12 weeks was safe and showed a dose-dependent immunological response, but no TSO dose showed a clinically relevant effect over placebo for induction of clinical remission or response in mildly-to-moderately active, ileocolonic CD.

P152 Role of inflammatory bowel disease in fertility of male patients P. Valer1 *, A. Algaba1, E. Nieto2, I. Guerra1, M. Chaparro3, P. Lopez-Serrano4, E. Quintanilla5, B. Piqueras1, A. Bermejo1, J.P. Gisbert3, A. Paez6, F. Bermejo1. 1Hospital Universitario de Fuenlabrada, Gastroenterology, Fuenlabrada, Spain, 2Hospital Universitario de Fuenlabrada, Laboratory, Fuenlabrada, Spain, 3Hospital Universitario de La Princesa, and Instituto de Investigacion Sanitaria Princesa (IP), Madrid Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBERehd), Gastroenterology, Madrid, Spain, 4Hospital Universitario Fundacion Alcorcon, Gastroenterology, Alcorcon, Spain, 5Hospital Severo Ochoa, Gastroenterology, Leganes, Spain, 6Hospital Universitario de Fuenlabrada, Urology, Fuenlabrada, Spain

OP19 Genetic and functional evidence for a role for CYLD in Crohn’s disease: Results from a European consortium I. Cleynen1 *, E. Vazeille2, M. Artieda3, M. Szczypiorska3, M.-A. Bringer2, H. Verspaget4, P. Lakatos5, F. Seibold6, K. Parnell7, R. Weersma8, J. Mahachie9, R. Morgan-Walsh10, D. Staelens1, I. Arijs1, S. Muller11, A. Tordai12, D.W. Hommes13, T. Ahmad14, C. Wijmenga15, S. Pender10, P. Rutgeerts16, D. Lottaz11, K. Van Steen9, S. Vermeire16, A. DarfeuilleMichaud2. 1Catholic University Leuven, Gastroenterology, Leuven, Belgium, 2Universite d’Auvergne, Inserm U1071, France, 3Progenika Biopharma, S.A., Derio, Spain, 4Leiden University Medical Center, Department of Gastroenterology & Hepatology, Leiden, Netherlands, 5Semmelweis University, 1st Department of Medicine, Budapest, Hungary, 6Spitalnetz Bern, Switzerland, 7Peninsula Medical School, United Kingdom, 8University Medical Center Groningen, Gastroenterology and Hepatology, Groningen, Netherlands, 9University of Liege, Liege, Belgium, 10University of Southampton, United Kingdom, 11University of Bern, Bern, Switzerland, 12Hungarian National Blood Transfusion Service, Molecular Diagnostics, Hungary, 13UCLA, Division of Digestive Diseases, Los Angeles, United States, 14Royal Devon & Exeter Hospital, Gastroenterology RM B205, Exeter, United Kingdom, 15University Medical Center Groningen, Groningen, Netherlands, 16University Hospital Gasthuisberg, Department of Gastroenterology, Leuven, Belgium

OP11 Individualised infliximab treatment using therapeutic drug monitoring: A prospective controlled Trough level Adapted infliXImab Treatment (TAXIT) trial N. Vande Casteele1 *, G. Compernolle1, V. Ballet2, G. Van Assche2, A. Gils1, S. Vermeire2, P. Rutgeerts2. 1Katholieke Universiteit Leuven, Laboratory for Pharmaceutical Biology, Belgium, 2University Hospitals Leuven, Department of Gastroenterology, Leuven, Belgium