Evidence map›Paper›PMID 29228964›Full record

Trial reportJournal of translational medicine2017

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.

Shaun Sabico, Ayah Al-Mashharawi, Nasser M Al-Daghri, Sobhy Yakout, Abdullah M Alnaami, Majed S Alokail, Philip G McTernan

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of translational medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01765517 (A 26-week, Randomized, Double-blind, Placebo-controlled Study to Explore the Effects of Probiotics on Endotoxin Levels in Patients With Type 2 Diabetes Mellitus), which is not on this map. Cited by 56 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 11 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01765517 nacompletednot on this map

A 26-week, Randomized, Double-blind, Placebo-controlled Study to Explore the Effects of Probiotics on Endotoxin Levels in Patients With Type 2 Diabetes Mellitus

TypeinterventionalSponsorKing Saud UniversityRan2013 to 2017Enrolled83ConditionsDiabetes Mellitus Type 2ArmsProbiotics, Placebo
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 11 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Shaun SabicoDivision 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.ORCID http://orcid.org/0000-0002-5248-2350
Ayah Al-MashharawiBiochemistry Department, Prince Mutaib Chair for Biomarkers of Osteoporosis, College of Science, King Saud University, PO Box 2455, Riyadh, 11451, Kingdom of Saudi Arabia.
Nasser M Al-DaghriBiochemistry Department, Prince Mutaib Chair for Biomarkers of Osteoporosis, College of Science, King Saud University, PO Box 2455, Riyadh, 11451, Kingdom of Saudi Arabia.
Sobhy YakoutBiochemistry Department, Prince Mutaib Chair for Biomarkers of Osteoporosis, College of Science, King Saud University, PO Box 2455, Riyadh, 11451, Kingdom of Saudi Arabia.
Abdullah M AlnaamiBiochemistry Department, Prince Mutaib Chair for Biomarkers of Osteoporosis, College of Science, King Saud University, PO Box 2455, Riyadh, 11451, Kingdom of Saudi Arabia.
Majed S AlokailBiochemistry Department, Prince Mutaib Chair for Biomarkers of Osteoporosis, College of Science, King Saud University, PO Box 2455, Riyadh, 11451, Kingdom of Saudi Arabia.
Philip G McTernanSchool of Science and Technology, Nottingham Trent University, Nottingham, NG1 8NS, UK.

Funding

National Plan for Science, Technology and Innovation 11-MED2114-02
6 · The paper itself

Abstract

backgroundThe 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.

methodsA 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 × 10

resultsAfter 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)].

conclusionUsing 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 registrationClinicalTrials.gov Identifier: NCT01765517 , Registered January 10, 2013.

Indexed as

Dietary SupplementsAnthropometryBlood GlucoseDiabetes Mellitus, Type 2EndotoxinsFemaleHumansHypoglycemic AgentsIntention to Treat AnalysisLipidsMaleMiddle AgedMyocardiumPlacebosProbioticsBlood GlucoseEndotoxinsHypoglycemic AgentsLipidsPlacebosClinical trialEndotoxinLipidsProbioticsType 2 diabetes mellitus

Identifiers

PMID29228964
PMCPMC5725828

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.