Randomised clinical trial: exclusive enteral nutrition versus standard of care for acute severe ulcerative colitis.
Journal
Alimentary pharmacology & therapeutics
ISSN: 1365-2036
Titre abrégé: Aliment Pharmacol Ther
Pays: England
ID NLM: 8707234
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
10
10
2020
revised:
28
10
2020
accepted:
19
12
2020
pubmed:
14
1
2021
medline:
1
4
2021
entrez:
13
1
2021
Statut:
ppublish
Résumé
Intravenous corticosteroids are the mainstay of therapy for acute severe ulcerative colitis (ASUC), but 30%-40% of patients fail to respond. To investigate the effectiveness of exclusive enteral nutrition (EEN) as adjunctive therapy to intravenous corticosteroids in patients with ASUC. 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. 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. EEN for 7 days may augment corticosteroid responsiveness in patients with ASUC. (REF/2018/05/019844; CTRI/2020/06/025989).
Sections du résumé
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).
Substances chimiques
Leukocyte L1 Antigen Complex
0
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
568-576Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : ErratumIn
Informations de copyright
© 2020 John Wiley & Sons Ltd.
Références
Dignass A, Eliakim R, Magro F, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis Part 1: definitions and diagnosis. J Crohns Colitis. 2012;6:965-990.
Dinesen LC, Walsh AJ, Protic MN, et al. The pattern and outcome of acute severe colitis. J Crohns Colitis. 2010;4:431-437.
Truelove SC, Witts LJ. Cortisone in ulcerative colitis; final report on a therapeutic trial. Br Med J. 1955;2:1041-1048.
Turner D, Walsh CM, Steinhart AH, Griffiths AM. Response to corticosteroids in severe ulcerative colitis: a systematic review of the literature and a meta-regression. Clin Gastroenterol Hepatol. 2007;5:103-110.
Llao J, Naves JE, Cerulla AR, et al. Improved outcomes of acute severe ulcerative colitis while using early predictors of corticosteroid failure and rescue therapies. Dig Liv Dis. 2016;18:608-612.
Leeds IL, Truta B, Parian AM, et al. Early surgical intervention for acute ulcerative colitis is associated with improved postoperative outcomes. J Gastrointest Surg. 2017;21:1675-1682.
Williams JG, Alam MF, Alrubaiy L, et al. Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial. Lancet Gastroenterol Hepatol. 2016;1:15-24.
McIntyre PB, Powell-Tuck J, Wood SR, et al. Controlled trial of bowel rest in the treatment of severe acute colitis. Gut. 1986;27:481-485.
Gonzalez-Huix F, Fernández-Bañares F, Esteve-Comas M, et al. Enteral versus parenteral nutrition as adjunct therapy in acute ulcerative colitis. Am J Gastroenterol. 1993;88:227-232.
Dickinson RJ, Ashton MG, Axon AT, Smith RC, Yeung CK, Hill GL. Controlled trial of intravenous hyperalimentation and total bowel rest as an adjunct to the routine therapy of acute colitis. Gastroenterology. 1980;79:1199-1204.
Zachos M, Tondeur M, Griffiths AM. Enteral nutritional therapy for induction of remission in Crohn’s disease. Cochrane Database Syst Rev. 2007;(1):CD000542.
Ruemmele FM, Veres G, Kolho KL, et al. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn's disease. J Crohns Colitis. 2014;8:1179-1207.
Wall CL, Day AS, Gearry RB. Use of exclusive enteral nutrition in adults with Crohn's disease: a review. World J Gastroenterol. 2013;19:7652-7660.
Buchanan E, Gaunt WW, Cardigan T, Garrick V, McGrogan P, Russell RK. The use of exclusive enteral nutrition for induction of remission in children with Crohn's disease demonstrates that disease phenotype does not influence clinical remission. Aliment Pharmacol Ther. 2009;30:501-507.
Travis SPL, Schnell D, Krzeski P, et al. Reliability and initial validation of the ulcerative colitis endoscopic index of severity. Gastroenterology. 2013;145:987-995.
Harbord M, Eliakim R, Bettenworth D, et al. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 2: Current Management. J Crohns Colitis. 2017;11:769-784.
Travis SP, Farrant JM, Ricketts C, et al. Predicting outcome in severe ulcerative colitis. Gut. 1996;38:905-910.
Klein S. A primer of nutritional support for gastroenterologists. Gastroenterology. 2002;122:1677-1687.
Bag S, Saha B, Mehta O, et al. An improved method for high quality metagenomics DNA extraction from human and environmental samples. Sci Rep. 2016;6. https://doi.org/10.1038/srep26775
Bolyen E, Rideout JR, Dillon MR, et al. Reproducible, interactive, scalable and extensible microbiome data science using QIIME 2. Nat Biotechnol. 2019;37:852-857.
Jain S, Kedia S, Bopanna S, et al. Faecal calprotectin and UCEIS predict short-term outcomes in acute severe colitis: prospective cohort study. J Crohns Colitis. 2017;1309-1316.
Corte CJ, Fernandopulle AN, Catuneanu A, et al. Correlation between the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and outcomes in acute severe ulcerative colitis. Gastroenterology. 2013;144:S-102.
Ho GT, Lee HM, Brydon G, et al. Faecal calprotectin predicts the clinical course of acute severe ulcerative colitis. Am J Gastroenterol. 2009;104:673-678.
Levine A, Wine E. Effects of enteral nutrition on Crohn's disease: clues to the impact of diet on disease pathogenesis. Inflamm Bowel Dis. 2013;19:1322-1329.
Forbes A, Escher J, Hébuterne X, et al. ESPEN guideline: Clinical nutrition in inflammatory bowel disease. Clin Nutr. 2017;36:321-347.
Hirai F, Takeda T, Takada Y, et al. Efficacy of enteral nutrition in patients with Crohn’s disease on maintenance anti-TNF-alpha antibody therapy: a meta-analysis. J Gastroenterol. 2020;55:133-141.
Bannerjee K, Camacho-Hübner C, Babinska K, et al. Anti-inflammatory and growth-stimulating effects precede nutritional restitution during enteral feeding in Crohn disease. J Pediatr Gastroenterol Nutr. 2004;38:270-275.
Logan M, Clark CM, Ijaz UZ, et al. The reduction of faecal calprotectin during exclusive enteral nutrition is lost rapidly after food re-introduction. Aliment Pharmacol Ther. 2019;50:664-674.
Baut GL, Kirchgesner J, Amiot A, et al. A scoring system to determine patients’ risk of colectomy within 1 y after hospital admission for acute severe ulcerative colitis. Clin Gastroenterol Hepatol. 2020;10:S1542-3565(20)30029-X. https://doi.org/10.1016/j.cgh.2019.12.036
Jain S, Kedia S, Sethi T, et al. Predictors of long-term outcome in patients with acute severe colitis: a northern Indian cohort study. J Gastroenterol Hepatol. 2018;33:615-622.
Gevers D, Kugathasan S, Denson L, et al. The treatment-naive microbiome in new-onset Crohn’s disease. Cell Host Microbe. 2014;15:382-392.
Levine A, Wine E, Assa A, et al. Crohn's disease exclusion diet and partial enteral nutrition induces sustained remission in a randomized controlled trial. Gastroenterology. 2019;157:440-450.
Bojic D, Radojicic Z, Nedeljkovic-Protic M, et al. Long-term outcome after admission for acute severe ulcerative colitis in Oxford: the 1992-1993 cohort. Inflamm Bowel Dis. 2009;15:823-828.