Background: We evaluated whether integration of novel diets for donors and patients, in addition to faecal transplantation [FT], could increase FT remission rate in refractory ulcerative colitis [UC]. Methods: This was a blinded, randomised, controlled trial in adults with active 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 single donor standard FT by colonoscopy on Day 1and rectal enemas on Days 2 and 14 without dietary conditioning of the donor. Group 2 received FT as above but with dietary pre-conditioning of the donor for 14 days and a UC Exclusion Diet [UCED] for the patients. Group 3 received the UCED alone. The primary endpoint was Week 8 clinical steroid-free remission, defined as SCCAI <3. Results: Of 96 planned patients, 62 were enrolled. Remission Week 8 Group 1 was 2/17 [11.8%], Group 2 was 4/19 [21.1%], Group 3 was 6/15 [40%] [non-significant]. Endoscopic remission Group 1 was 2/17 [12%], Group 2 was 3/19 [16%], Group 3 was 4/15 [27%] [Group 1 vs 3 p = 0.38]. Mucosal healing [Mayo 0] was achieved only in Group 3 [3/15, 20%] vs 0/36 FT patients [p = 0.022]. Exacerbation of disease occurred in 3/17 [17.6%] of Group 1, 4/19 [21.1%] of Group 2, and 1/15 [6.7%] of Group 3 [Group 2 vs 3, p = 0.35]. Conclusions: UCED alone appeared to achieve higher clinical remission and mucosal healing than single donor FT with or without diet. The study was stopped for futility by a safety monitoring board.

Shabat, C. S., Scaldaferri, F., Zittan, E., Hirsch, A., Mentella, M. C., Musca, T., Cohen, N. A., Ron, Y., Isakov, N. F., Pfeffer, J., Yaakov, M., Fanali, C., Turchini, L., Masucci, L., Quaranta, G., Kolonimos, N., Godneva, A., Weinberger, A., Kopylov, U., Levine, A., Maharshak, N., Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial, <<JOURNAL OF CROHN'S AND COLITIS>>, 2022; 16 (3): 369-378. [doi:10.1093/ecco-jcc/jjab165] [http://hdl.handle.net/10807/203847]

Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial

Scaldaferri, Franco;Mentella, Maria Chiara;Musca, Tania;Fanali, Chiara;Turchini, Laura;Masucci, Luca;Quaranta, Gianluca;
2022

Abstract

Background: We evaluated whether integration of novel diets for donors and patients, in addition to faecal transplantation [FT], could increase FT remission rate in refractory ulcerative colitis [UC]. Methods: This was a blinded, randomised, controlled trial in adults with active 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 single donor standard FT by colonoscopy on Day 1and rectal enemas on Days 2 and 14 without dietary conditioning of the donor. Group 2 received FT as above but with dietary pre-conditioning of the donor for 14 days and a UC Exclusion Diet [UCED] for the patients. Group 3 received the UCED alone. The primary endpoint was Week 8 clinical steroid-free remission, defined as SCCAI <3. Results: Of 96 planned patients, 62 were enrolled. Remission Week 8 Group 1 was 2/17 [11.8%], Group 2 was 4/19 [21.1%], Group 3 was 6/15 [40%] [non-significant]. Endoscopic remission Group 1 was 2/17 [12%], Group 2 was 3/19 [16%], Group 3 was 4/15 [27%] [Group 1 vs 3 p = 0.38]. Mucosal healing [Mayo 0] was achieved only in Group 3 [3/15, 20%] vs 0/36 FT patients [p = 0.022]. Exacerbation of disease occurred in 3/17 [17.6%] of Group 1, 4/19 [21.1%] of Group 2, and 1/15 [6.7%] of Group 3 [Group 2 vs 3, p = 0.35]. Conclusions: UCED alone appeared to achieve higher clinical remission and mucosal healing than single donor FT with or without diet. The study was stopped for futility by a safety monitoring board.
2022
Inglese
Shabat, C. S., Scaldaferri, F., Zittan, E., Hirsch, A., Mentella, M. C., Musca, T., Cohen, N. A., Ron, Y., Isakov, N. F., Pfeffer, J., Yaakov, M., Fanali, C., Turchini, L., Masucci, L., Quaranta, G., Kolonimos, N., Godneva, A., Weinberger, A., Kopylov, U., Levine, A., Maharshak, N., Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial, <<JOURNAL OF CROHN'S AND COLITIS>>, 2022; 16 (3): 369-378. [doi:10.1093/ecco-jcc/jjab165] [http://hdl.handle.net/10807/203847]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/203847
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