An Oral Formulation of the Probiotic,
Journal
Evidence-based complementary and alternative medicine : eCAM
ISSN: 1741-427X
Titre abrégé: Evid Based Complement Alternat Med
Pays: United States
ID NLM: 101215021
Informations de publication
Date de publication:
2020
2020
Historique:
received:
03
11
2019
accepted:
25
05
2020
entrez:
28
7
2020
pubmed:
28
7
2020
medline:
28
7
2020
Statut:
epublish
Résumé
Hepatic encephalopathy often results in high blood ammonia levels because of inefficient ammonia processing by the liver. Lactulose treatment promotes the growth of urease-producing gut bacteria and a reduced colon pH, thus reducing blood ammonia absorption. It is thought that probiotics as an add-on therapy may be beneficial. Forty patients participated (placebo, 11; probiotic, 29). Baseline characteristics were generally comparable; the mean baseline blood ammonia level was somewhat higher in the probiotic group. Mild or moderate treatment-emergent adverse events (TEAEs) were reported in 27.3% and 17.2% of patients in the placebo and probiotic groups, respectively; no severe TEAEs were reported. One patient (9.1%) taking placebo and two (6.9%) taking the probiotic experienced serious TEAEs (SAEs); none resulted in study discontinuation and all were considered to have no/unlikely relationship to the study product. There were no significant differences in the mean percent change (MPC) of blood ammonia levels between groups, though the probiotic group exhibited a trend toward a milder increase. Stratification of the probiotic group by baseline blood ammonia level (>60 Daily treatment with oral
Sections du résumé
BACKGROUND
BACKGROUND
Hepatic encephalopathy often results in high blood ammonia levels because of inefficient ammonia processing by the liver. Lactulose treatment promotes the growth of urease-producing gut bacteria and a reduced colon pH, thus reducing blood ammonia absorption. It is thought that probiotics as an add-on therapy may be beneficial.
RESULTS
RESULTS
Forty patients participated (placebo, 11; probiotic, 29). Baseline characteristics were generally comparable; the mean baseline blood ammonia level was somewhat higher in the probiotic group. Mild or moderate treatment-emergent adverse events (TEAEs) were reported in 27.3% and 17.2% of patients in the placebo and probiotic groups, respectively; no severe TEAEs were reported. One patient (9.1%) taking placebo and two (6.9%) taking the probiotic experienced serious TEAEs (SAEs); none resulted in study discontinuation and all were considered to have no/unlikely relationship to the study product. There were no significant differences in the mean percent change (MPC) of blood ammonia levels between groups, though the probiotic group exhibited a trend toward a milder increase. Stratification of the probiotic group by baseline blood ammonia level (>60
CONCLUSIONS
CONCLUSIONS
Daily treatment with oral
Identifiants
pubmed: 32714397
doi: 10.1155/2020/1463108
pmc: PMC7345602
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1463108Informations de copyright
Copyright © 2020 Sayed Yossef et al.
Déclaration de conflit d'intérêts
Thomas Bayne, Kiran Krishnan, and Aicacia Young are employees of Microbiome Labs. John Abernathy and Sarah Bubeck have received payments from Microbiome Labs.
Références
Cochrane Database Syst Rev. 2017 Feb 23;2:CD008716
pubmed: 28230908
Neurochem Pathol. 1987 Feb-Apr;6(1-2):1-12
pubmed: 3306479
Ann Hepatol. 2011 Jun;10 Suppl 2:S60-5
pubmed: 22228884
Intensive Care Med. 2013 Jul;39(7):1227-37
pubmed: 23636826
N Engl J Med. 2016 Oct 27;375(17):1660-1670
pubmed: 27783916
Front Microbiol. 2017 Aug 10;8:1490
pubmed: 28848511
Nutrients. 2018 Jan 28;10(2):
pubmed: 29382084
Clin Gastroenterol Hepatol. 2014 Jun;12(6):1003-8.e1
pubmed: 24246768
Res Microbiol. 2009 Jul-Aug;160(6):375-9
pubmed: 19589385
Clin Gastroenterol Hepatol. 2016 Jun;14(6):903-906.e1
pubmed: 26707685
Res Microbiol. 2009 Mar;160(2):134-43
pubmed: 19068230
J Nutr. 2015 Jul;145(7):1446-52
pubmed: 25948780
Aliment Pharmacol Ther. 2011 Mar;33(6):662-71
pubmed: 21251030
Regul Toxicol Pharmacol. 2017 Feb;83:54-65
pubmed: 27825987
J Gastroenterol Hepatol. 2019 Jan;34(1):31-39
pubmed: 30070387
World J Gastrointest Pathophysiol. 2017 Aug 15;8(3):117-126
pubmed: 28868181
Crit Rev Microbiol. 1996;22(2):101-38
pubmed: 8817079
J Clin Gastroenterol. 2017 Apr;51(4):312-323
pubmed: 28059938
Food Microbiol. 2011 Apr;28(2):214-20
pubmed: 21315976
J Bacteriol. 2006 Apr;188(7):2692-700
pubmed: 16547057
Gut. 2006 Jan;55(1):98-104
pubmed: 16024550
J Hosp Med. 2017 Aug;12(8):659-661
pubmed: 28786433
Liver Int. 2016 Jul;36(7):986-93
pubmed: 26561214