Trial reportTrials2013
Effects of probiotics in patients with diabetes mellitus type 2: study protocol for a randomized, double-blind, placebo-controlled trial.
Trial report in Trials, 2013. 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 15 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
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
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Effects of Probiotic Supplement in Pregnant Women with Gestational Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Journal of diabetes research · 2019Pooled it
- Effect of Probiotics on the Glucose Levels of Pregnant Women: A Meta-Analysis of Randomized Controlled Trials.Medicina (Kaunas, Lithuania) · 2018Pooled it
- 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.Journal of translational medicine · 2017Trial
- Is there a value for probiotic supplements in gestational diabetes mellitus? A randomized clinical trial.Journal of health, population, and nutrition · 2015Trial
- Effects of Synbiotics on Inflammatory Markers in Patients With Type 2 Diabetes Mellitus.Global journal of health science · 2015Trial
- Effect of Gegen Qinlian Decoction on the regulation of gut microbiota and metabolites in type II diabetic rats.Frontiers in microbiology · 2024Article
- Could probiotics protect against human toxicity caused by polystyrene nanoplastics and microplastics?Frontiers in nutrition · 2023Review
- Gut microbiota as a target for prevention and treatment of type 2 diabetes: Mechanisms and dietary natural products.World journal of diabetes · 2021Review
- The Effects of Soy Milk Enriched with Lactobacillus casei and Omega-3 on the Tibia and L5 Vertebra in Diabetic Rats: a Stereological Study.Probiotics and antimicrobial proteins · 2019Article
- Do Probiotics Improve the Health Status of Individuals with Diabetes Mellitus? A Review on Outcomes of Clinical Trials.BioMed research international · 2019Review
- Nutrigenomics and its Impact on Life Style Associated Metabolic Diseases.Current genomics · 2016Article
- Perspectives on the probiotic potential of lactic acid bacteria from African traditional fermented foods and beverages.Food & nutrition research · 2016Review
- Roles of Commensal Microbiota in Pancreas Homeostasis and Pancreatic Pathologies.Journal of diabetes research · 2015Review
- Effects of Probiotic Supplementation on Pancreatic β-cell Function and C-reactive Protein in Women with Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Clinical Trial.International journal of preventive medicine · 2015Article
- IMPLICATION OF GUT MICROBIOTA IN DIABETES MELLITUS AND OBESITY.Acta endocrinologica (Bucharest, Romania : 2005)Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLow 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.
methodsOne hundred and twenty consenting adult Saudi T2DM patients (naïve or newly diagnosed and without co-morbidities) will be enrolled in this clinical trial and randomized to receive daily placebo or probiotics (Ecologic®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 registrationClinicalTrials.gov Identifier: NCT01765517.
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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 OpenQuestion graph.