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DOP65 Dietary therapy with the Crohn’s Disease exclusion diet induces sustained clinical and endoscopic remission in adults with Mild to Moderate Crohn's Disease: Results from the CDED-AD trial

Yanai, H.(1,2);Levine , A.(2,3);Hirsch , A.(2,4);Sigall Boneh , R.(2,5);Kopylov , U.(2,6);Banai Eran, H.(1,2); Cohen, N.A.(2,4);Ron, Y.(2,4);Goren , I.(1,2);Leibovitzh, H.(1,2);Wardi , J.(2,7);Zittan, E.(8);Ziv-Baran , T.(2);Abramas, L.(5);Fliss-Isakov , N.(2,4);Raykhel, B.(1);Pfeffer Gik , T.(1,2);Dotan , I.(1,2);Maharshak, N.(2,4)

(1)Rabin Medical Center, IBD center- Division of Gastroenterology, Petah Tikva, Israel;(2)Tel Aviv University, Sackler Faculty of Medicine, Tel Aviv, Israel;(3)Wolfson Medical Center, Paediatric Gastroenterology Unit, Holon, Israel;(4)Tel Aviv Sourasky Medical Center, Department of Gastroenterology and Hepatology, Tel Aviv, Israel;(5)Wolfson Medical Center, Israel PIBD Research Center, Holon, Israel;(6)Sheba Medical Center- Tel Hashomer-, Department of Gastroenterology, Ramat-Gan, Israel;(7)Wolfson Medical Center, Gastroenterology Institute, Holon, Israel;(8)Emek Medical Center, Institute of Gastroenterology and Liver Diseases- IBD unit, Afula, Israel

Background

Crohn’s disease exclusion diet (CDED) with partial enteral nutrition (PEN) is effective for induction of remission in children with mild-moderate Crohn’s disease (CD). Here we evaluated CDED in adults with CD.

Methods

This was an open-label prospective randomized controlled pilot trial in patients with mild-moderate CD defined as Harvey-Bradshaw Index (HBI) between 5-14, active disease on colonoscopy, or imaging with calprotectin>200 μ/gr. Group-I received CDED+PEN, and Group-II CDED-alone. A colonoscopy was performed at week-24. Endoscopic remission (ER) was defined as Simple Endoscopic Score for CD (SES-CD)≤3. The primary end-point was corticosteroid (CS) free remission defined as HBI<5 at week-6.

Results

Forty patients were included (median age 30 years [IQR;24-39], 19 patients- Group-I, 21 patients- Group-II). By intention-to-treat (ITT) analysis CS-free remission at week-6 was  62.5% of patients (25/40), comparable between Group-I 68.4%(13/19) vs.Group-II: 57.1%(12/21) (P=.46). Among remitters at week-6, sustained remission was present in 88%(22/25) week-12, and 80%(20/25) week-24. For patients with baseline elevated C-reactive protein (CRP) (n=30), median CRP decreased from 14.5 mg/L [IQR;7.7-37] to 8.4[IQR;5.4-18.5] at week6(P=.006), and to 8[IQR;5.4-20.6] week-24(P=.002). ER at week-24 was present in 14/28 patients (50%) and was 14/40(35%) by ITT. ER week-24 was similar between groups, 8/15(53.3%) vs. 6/13(46.1%) (P=.7). A comparison between baseline and week-24 SES-CD revealed a median of 5-points decrease (IQR; [-6.25]-[-1]), corresponding to 72.8% (IQR;20-100%) decline from baseline (P=.003).

Conclusion

CDED with or without PEN was effective for induction and maintenance of remission in adults with mild to moderate CD and may lead to endoscopic remission.

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