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J Transl Med. 2017 Dec 11;15(1):249. doi: 10.1186/s12967-017-1354-x.

Effects of a multi-strain probiotic supplement for 12 weeks in circulating endotoxin levels and cardiometabolic profiles of medication naïve T2DM patients: a randomized clinical trial.

Author information

1
Division of Biomedical Sciences, Warwick Medical School, University of Warwick, UHCW Trust, Clifford Bridge Road, Walsgrave, Coventry, CV2 2DX, UK. s.l.sabico@warwick.ac.uk.
2
Biochemistry Department, Prince Mutaib Chair for Biomarkers of Osteoporosis, College of Science, King Saud University, PO Box 2455, Riyadh, 11451, Kingdom of Saudi Arabia. s.l.sabico@warwick.ac.uk.
3
Biochemistry Department, Prince Mutaib Chair for Biomarkers of Osteoporosis, College of Science, King Saud University, PO Box 2455, Riyadh, 11451, Kingdom of Saudi Arabia.
4
School of Science and Technology, Nottingham Trent University, Nottingham, NG1 8NS, UK.

Abstract

BACKGROUND:

The present randomized clinical trial characterized the beneficial effects of a multi-strain probiotics supplementation on improving circulating endotoxin levels (primary endpoint) and other cardiometabolic biomarkers (secondary endpoint) in patients with T2DM.

METHODS:

A total of 78 adult Saudi T2DM patients (naïve and without co-morbidities) participated in this clinical trial and were randomized to receive twice daily placebo or probiotics [(2.5 × 109 cfu/g) containing the following bacterial strains: Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58 (Ecologic®Barrier)] in a double-blind manner for 12 weeks. Anthropometrics and cardiometabolic profiles were obtained at baseline and after 12/13 weeks of treatment.

RESULTS:

After 12/13 weeks of intervention and using intention-to-treat analysis, no difference was noted in endotoxin levels between groups [Placebo - 9.5% vs. Probiotics - 52.2%; (CI - 0.05 to 0.36; p = 0.15)]. Compared with the placebo group however, participants in the probiotics groups had a significant but modest improvement in WHR [Placebo 0.0% vs. Probiotics 1.11%; (CI - 0.12 to - 0.01; p = 0.02)] as well as a clinically significant improvement in HOMA-IR [Placebo - 12.2% vs. Probiotics - 60.4%; (CI - 0.34 to - 0.01; p = 0.04)].

CONCLUSION:

Using a multi-strain probiotic supplement daily for 12/13 weeks significantly improved HOMA-IR and modestly reduced abdominal adiposity among medication naïve T2DM patients.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT01765517 , Registered January 10, 2013.

KEYWORDS:

Clinical trial; Endotoxin; Lipids; Probiotics; Type 2 diabetes mellitus

PMID:
29228964
PMCID:
PMC5725828
DOI:
10.1186/s12967-017-1354-x
[Indexed for MEDLINE]
Free PMC Article

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