Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial.
Ulcerative colitis
diet
faecal transplantation
fibre
microbiome
Journal
Journal of Crohn's & colitis
ISSN: 1876-4479
Titre abrégé: J Crohns Colitis
Pays: England
ID NLM: 101318676
Informations de publication
Date de publication:
14 Mar 2022
14 Mar 2022
Historique:
pubmed:
14
9
2021
medline:
17
3
2022
entrez:
13
9
2021
Statut:
ppublish
Résumé
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]. 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. 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]. 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 34514495
pii: 6369227
doi: 10.1093/ecco-jcc/jjab165
pmc: PMC8919830
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
369-378Subventions
Organisme : Azrieli Foundation
Commentaires et corrections
Type : CommentIn
Informations de copyright
© The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.
Références
Gastroenterology. 2015 Jul;149(1):110-118.e4
pubmed: 25836986
Inflamm Bowel Dis. 2017 Jan;23(1):116-125
pubmed: 27893543
Inflamm Bowel Dis. 2020 Jan 1;26(1):43-55
pubmed: 31211831
Gut. 2014 Feb;63(2):281-91
pubmed: 23426893
Proc Natl Acad Sci U S A. 2016 Oct 4;113(40):E5934-E5943
pubmed: 27638207
Transplant Proc. 2016 Mar;48(2):402-7
pubmed: 27109966
Nature. 2014 Jan 23;505(7484):559-63
pubmed: 24336217
Gastroenterology. 2019 Aug;157(2):440-450.e8
pubmed: 31170412
Gut. 2015 Apr;64(4):562-70
pubmed: 25037189
Science. 2015 Sep 4;349(6252):1101-1106
pubmed: 26229116
Nat Methods. 2012 Mar 04;9(4):357-9
pubmed: 22388286
Aliment Pharmacol Ther. 2021 Mar;53(5):568-576
pubmed: 33440046
ISME J. 2017 Aug;11(8):1877-1889
pubmed: 28398347
Cell. 2019 Jan 24;176(3):649-662.e20
pubmed: 30661755
Gut. 2019 Oct;68(10):1801-1812
pubmed: 30670576
Aliment Pharmacol Ther. 2017 Aug;46(3):213-224
pubmed: 28612983
Lancet. 2017 Mar 25;389(10075):1218-1228
pubmed: 28214091
Gastroenterology. 2018 Mar;154(4):1037-1046.e2
pubmed: 29174952
Clin J Gastroenterol. 2018 Feb;11(1):1-10
pubmed: 29285689
Gut. 2019 Dec;68(12):2111-2121
pubmed: 31563878
Inflamm Bowel Dis. 2020 Oct 23;26(11):1733-1742
pubmed: 31833543
Gut. 2019 Dec;68(12):2142-2151
pubmed: 30914450
Biomed Res Int. 2018 Sep 13;2018:8941340
pubmed: 30302341
Nutrients. 2017 Mar 21;9(3):
pubmed: 28335546
BMJ Case Rep. 2020 Aug 24;13(8):
pubmed: 32843418
Gastroenterology. 2015 Jul;149(1):102-109.e6
pubmed: 25857665
Front Pediatr. 2021 Feb 02;9:626232
pubmed: 33604319
JAMA. 2019 Jan 15;321(2):156-164
pubmed: 30644982
Inflamm Bowel Dis. 2014 Apr;20(4):723-31
pubmed: 24583479
Int J Food Sci Nutr. 2014 Feb;65(1):79-88
pubmed: 23941288