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Randomised clinical trial: exclusive enteral nutrition versus standard of care for acute severe ulcerative colitis
Author(s) -
Sahu Pabitra,
Kedia Saurabh,
Vuyyuru Sudheer K.,
Bajaj Aditya,
Markandey Manasvini,
Singh Namrata,
Singh Mukesh,
Kante Bhaskar,
Kumar Peeyush,
Ranjan Mukesh,
Sahni Peush,
Panwar Rajesh,
Sharma Raju,
Das Prasenjit,
Makharia Govind,
Travis Simon P. L.,
Ahuja Vineet
Publication year - 2021
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.16249
Subject(s) - medicine , colectomy , ulcerative colitis , gastroenterology , randomized controlled trial , enteral administration , parenteral nutrition , surgery , disease
Summary 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).