P398 An Open-label, Pilot Study to Assess Feasibility and Safety of Fecal Microbiota Transplantation in Patients with Mild-Moderate Ulcerative Colitis: preliminary results.
F. Scaldaferri*1, S. Pecere1, G. Bruno1, G. Ianiro1, L. Laterza1, V. Gerardi1, L. Lopetuso1, E. Schiavoni1, S. Bibbo1, F. Paroni Sterbini2, M. Sanguinetti2, L. Masucci2, A. Gasbarrini1, G. Cammarota1
1Catholic University of Sacred Heart, Internal Medicine Department, Gastroenterology division, Rome, Italy, 2Catholic University of Sacred Heart, Microbiology, Rome, Italy
Fecal microbiota therapy (FMT) has been successful in treating Clostridium difficile (CDI) colitis, while its possible application in the management of inflammatory bowel disease (IBD) remain unclear.
We report preliminary results of an open label feasibility trial on fecal microbiota transplantation in mild to moderate ulcerative colitis.
Outpatients affected by active ulcerative colitis (UC) (partial Mayo score major or equal to 4 with an endoscopic Mayo score major or equal to 1 with no upper limit on Mayo score), negative for C. difficile toxin were enrolled. Concomitant medications were admitted if stable 2 weeks before and thought the trial. Enrolled patients underwent to colonoscopy and received three administration of FMT using 200 cc of fecal slurry from an healthy donor proposed by the patient, negative for active infections. Primary outcome was feasibility and safety of FMT in UC. Secondary end points were: clinical remission defined as partial Mayo score minor or equal to 2 with no subscore major or equal to 1 and clinical response, defined as reduction of Mayo score of at least 2 points at week 2, 6, 12; endoscopic remission defined as Mayo score = 0 at week 6. Consecutive patients with similar clinical features, candidates to anti-TNF-a or immunosuppressant, acted as a "real life" controls (standard therapy, ST).
we enrolled 8 patients for FMT group and 7 patients for ST. Baseline characteristics were similar between FMT (6M, 2 F; mean age 37 ± 7 yo) and ST group ( 5M, 2 F, mean age 37 ± 10 yo): Pancolitis in 47%, left-side colitis in 33%; 80% were on steroids and 5-ASA, 40% on immunemodulators. In FMT group we observed: 1 SAE (kidney stone) and 2 drop out for disease worsening, while in ST group: 1 SAE (cerebral arterial thrombosis), 2 drop out for disease worsening, 1 infusion reaction. Clinical remission and clinical response for FMT and ST group were respectively: 37.5%/50% and 28.6%/28.6% at week 12, 25%/25% and 14.3%/57.1% at week 2, 25%/50% and 42.8%/42.8% at week 6. Endoscopic remission was observed in 33.3% of FMT group of patients while it was not evaluated in ST group.
The proposed protocol for FMT seems to be safe and well-accepted by UC patients. This FMT protocol have a good potential in inducing clinical response in real life mild-moderate UC patients. Further studies are mandatory.