PMID- 23822518
OWN - NLM
STAT- MEDLINE
DCOM- 20131017
LR  - 20220408
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 14
DP  - 2013 Jul 4
TI  - Effects of probiotics in patients with diabetes mellitus type 2: study protocol 
      for a randomized, double-blind, placebo-controlled trial.
PG  - 195
LID - 10.1186/1745-6215-14-195 [doi]
AB  - BACKGROUND: Low grade chronic inflammation is observed in patients with type 2 
      diabetes mellitus (T2DM). Endotoxin derived from gut bacteria may act as a potent 
      inflammatory stimulant. Probiotics, which are believed to contain health 
      promoting live microorganisms, may influence circulating endotoxin levels. 
      Ingestion of live probiotic cultures may alter gut microbiota in a beneficial 
      manner to reduce inflammation; no information is available whether or not they do 
      so in patients with T2DM. Therefore, the aim of this study is to characterize the 
      beneficial effects of probiotics on circulating endotoxin levels and other 
      biomarkers related to systemic low-grade inflammation in patients with T2DM. 
      METHODS: One hundred and twenty consenting adult Saudi T2DM patients (naive or 
      newly diagnosed and without co-morbidities) will be enrolled in this clinical 
      trial and randomized to receive daily placebo or probiotics (Ecologic(R)Barrier) 
      for 26 weeks in a double-blind manner. Inflammatory and metabolic markers will be 
      measured and fecal samples analyzed. Measurements/samples will be obtained at 
      baseline and after 4, 8, 12/13 and 26 weeks of treatment. DISCUSSION: It is 
      expected that the probiotic product will induce beneficial changes in gut 
      microbiota, reduce the systemic inflammatory state through altering systemic 
      endotoxin levels and, as such, reduce the systemic inflammatory response observed 
      in T2DM subjects. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01765517.
FAU - Alokail, Majed S
AU  - Alokail MS
AD  - Biomarkers Research Program, King Saud University, Riyadh 11451, Saudi Arabia. 
      msa85@yahoo.co.uk
FAU - Sabico, Shaun
AU  - Sabico S
FAU - Al-Saleh, Yousef
AU  - Al-Saleh Y
FAU - Al-Daghri, Nasser M
AU  - Al-Daghri NM
FAU - Alkharfy, Khalid M
AU  - Alkharfy KM
FAU - Vanhoutte, Paul M
AU  - Vanhoutte PM
FAU - McTernan, Philip G
AU  - McTernan PG
LA  - eng
SI  - ClinicalTrials.gov/NCT01765517
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130704
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Biomarkers)
RN  - 0 (Endotoxins)
RN  - 0 (Inflammation Mediators)
SB  - IM
MH  - Bacteria/*growth & development/metabolism
MH  - Biomarkers/blood
MH  - Clinical Protocols
MH  - Diabetes Mellitus, Type 2/blood/diagnosis/immunology/microbiology/*therapy
MH  - Double-Blind Method
MH  - Endotoxins/blood
MH  - Feces/chemistry/microbiology
MH  - Humans
MH  - Inflammation Mediators/blood
MH  - Intestines/*microbiology
MH  - Probiotics/adverse effects/*therapeutic use
MH  - *Research Design
MH  - Saudi Arabia
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC3708777
EDAT- 2013/07/05 06:00
MHDA- 2013/10/18 06:00
PMCR- 2013/07/04
CRDT- 2013/07/05 06:00
PHST- 2013/02/16 00:00 [received]
PHST- 2013/06/21 00:00 [accepted]
PHST- 2013/07/05 06:00 [entrez]
PHST- 2013/07/05 06:00 [pubmed]
PHST- 2013/10/18 06:00 [medline]
PHST- 2013/07/04 00:00 [pmc-release]
AID - 1745-6215-14-195 [pii]
AID - 10.1186/1745-6215-14-195 [doi]
PST - epublish
SO  - Trials. 2013 Jul 4;14:195. doi: 10.1186/1745-6215-14-195.