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OP01 Comparison of fecal transplantation, fecal transplantation with the novel UC diet or the UC diet alone for Refractory Mild to Moderate Active Ulcerative Colitis: The CRAFT UC randomized controlled trial

Levine, A.(1,2);Scaldaferri, F.(3,4);Sarbagili Shabat, C.(1,2);Zittan, E.(5);Hirsch, A.(2,6);Mentella, M.C.(7);Musca , T.(7);Cohen, N.A.(6);Ron, Y.(6);Fliss Isakov , N.(6);Pfeffer, J.(6);Yaakov, M.(1);Fanali, C.(4);Turchini , L.(4);Masucci, L.(8,9);Quaranta, G.(8,9);Anastasia, G.(10);Weinberger, A.(10);Kopylov , U.(2,11);Maharshak, N.(2,6)

(1)Edith Wolfson Medical Center, Pediatric Gastroenterology Unit- PIBD research center, Holon, Israel;(2)Tel Aviv University, Sackler School of Medicine, Tel Aviv, Israel;(3)"A. Gemelli” IRCSS, Università Cattolica del Sacro Cuore – Fondazione PoliclinicoDipartimento di Medicina e Chirurgia Traslazionale, Rome, Italy;(4)"A. Gemelli” IRCSS, Cemad CENTER for Digestive Disease- UOC Medicina Interna e Gastroenterologia Fondazione Policlinico, Rome, Italy;(5)Haemek Medical Center, Gastroenterology Institute- IBD Unit, Afula, Israel;(6)Tel Aviv Sourasky Medical Center, Department of Gastroenterology and Hepatology, Tel Aviv, Israel;(7)"A. Gemelli” IRCSS, UOC di Nutrizione Clinica- Medicina Interna- Gastroenterologia e Oncologia Medica Fondazione Policlinico, Rome, Italy;(8)"A. Gemelli” IRCSS, Istituto di Microbiologia Università Cattolica del Sacro Cuore – Fondazione Policlinico, Rome, Italy;(9)A. Gemelli IRCCS, Dipartimento Scienze di Laboratorio e Infettivologiche- Fondazione Policlinico Universitario, Rome, Italy;(10)Weizmann Institute of Science, Department of Computer Science and Applied Mathematics, Rehovot, Israel;(11)Sheba Medical Center, Department of Gastroenterology Division, Ramat Gan, Israel

Background

We evaluated if integration of novel diets for donors and patients in addition to fecal transplantation (FT) could increase FT remission in refractory ulcerative colitis (UC) or have an independent effect on remission. We developed a novel diet specifically designed for the dysbiosis of UC and to decrease factors that impair goblet cells or mucous production.

Methods

This was a blinded randomized controlled pilot trial in adults with UC, defined by a simple clinical colitis activity index (SCCAI) of ≥5 and < 11 and endoscopic Mayo score 2-3, refractory to medication. Group 1 received free diet and standard FT by colonoscopy on day 1and rectal enemas from a single donor on days 2 and 14 without dietary conditioning of the donor. Group 2: FT as above but with dietary pre-conditioning of the donor for 14 days and a diet (UC Diet- UCD) for the patients after FT. Group 3 received the UC Diet alone without FT. Patients underwent a repeat endoscopy at week 8. The primary endpoint was clinical steroid free remission, defined as SCCAI <3, at week 8.

Results

Fifty-one of the 96 planned patients were enrolled. The mean age was 40.4 ±12.5 years, 28/51(54.9%) had failed a biologic, 15/40 (29.4%) were on steroids at enrolment.  Remission week 8 in Group 1 was 2/17(11.8%), Group 2 was 4/19 (21.1%), and 6/15 (40%) Group 3 (NS).  Endoscopic remission was present in Group 1: 2/17(12%), Group 2: 3/19(16%) and 4/15 (27%) Group 3. Mucosal healing (Mayo 0) was achieved only in Group 3 (3/15, 20%) vs. 0/36 patients receiving FT (P=0.022). Exacerbation of disease occurred in 3/17 (17.6%) Group1, 4/19 (21.1%) Group 2, and 1/15 (6.7%) Group 3 (NS). The study was stopped for futility by a safety monitoring board.

Conclusion

Fecal transplantation was not effective in this UC cohort. A UC Diet alone appeared to achieve higher clinical remission (40%) and mucosal healing than single donor FT with or without diet in mild to moderate UC failing medical therapy. This diet should be investigated further in a RCT specifically designed for the UCD. This study was supported by an ECCO Pioneer grant

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