Randomised clinical trial: exclusive enteral nutrition versus standard of care

Randomised clinical trial: exclusive enteral nutrition versus standard of care for acute severe ulcerative colitis


Pabitra Sahu 1, Saurabh Kedia 1, Sudheer K Vuyyuru 1, Aditya Bajaj 1, Manasvini Markandey 1, Namrata Singh 1, Mukesh Singh 1, Bhaskar Kante 1, Peeyush Kumar 1, Mukesh Ranjan 1, Peush Sahni 2, Rajesh Panwar 2, Raju Sharma 3, Prasenjit Das 4, Govind Makharia 1, Simon P L Travis 5, Vineet Ahuja

https://pubmed.ncbi.nlm.nih.gov/33440046/

Published Mar 2021, in the Alimentary Pharmacology & Therapeutics


Abstract

Background: Intravenous corticosteroids are the mainstay of therapy for acute severe ulcerative colitis (ASUC), but 30%-40% of patients fail to respond.

Aim: To investigate the effectiveness of exclusive enteral nutrition (EEN) as adjunctive therapy to intravenous corticosteroids in patients with ASUC.

Methods: This was an open-label randomised controlled trial, in which patients who were admitted with ASUC between August 2018 and May 2020 were randomised 1:1 to EEN or standard of care (SOC). Patients on EEN received a semi-elemental formula for 7 days along with SOC. The primary outcome was corticosteroid failure, defined by the need for salvage medical therapy or colectomy. Faecal microbial analysis was performed on day 1 and day 7 by 16s ribosomal RNA sequencing in some patients.

Results: Of 62 patients (mean age 35.3 ± 12.1 years, 40% male), 32 were randomised to EEN and 30 to SOC. Corticosteroid failure was lower on EEN compared to SOC (intention-to-treat analysis 25% vs 43%, P = 0.051; per protocol analysis 19% vs 43%, P = 0.04), without any difference in colectomy rate (9% vs 13%; P = 0.41). Patients on EEN had a shorter hospital stay [median (range) 10 (8-17) vs 13 (8-24) days; P = 0.04], higher day 7 albumin level (34 ± 4 vs 29 ± 3 g/L, P < 0.01), greater reduction in serum C-reactive protein and faecal calprotectin levels (both P = 0.04) and a lower composite outcome of colectomy/hospitalisation at 6 months (16% vs 39%; P = 0.045) compared to SOC. Patients on EEN showed increased abundance of Erysipelotrichaceae on day 7, with reduced Bifidobacterium and Veillonellaceae compared to SOC.

Conclusions: EEN for 7 days may augment corticosteroid responsiveness in patients with ASUC. (REF/2018/05/019844; CTRI/2020/06/025989).

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