Efficacy of UB0316, a multi-strain probiotic formulation in patients with type 2 diabetes mellitus: A double blind, randomized, placebo controlled study

Madempudi, Ratna Sudha; Ahire, Jayesh J.; Neelamraju, Jayanthi; Tripathi, Anirudh; Nanal, Satyavrat

doi:10.1371/journal.pone.0225168

Cited by 65 publications

(53 citation statements)

References 30 publications

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“…The administration of a mixture of probiotics along with metformin helped in inhibiting the damage caused by the administration of AOM/DSS to Balb/c mice, through preventing weight loss, ameliorating the DAI, reducing the production of polyps, ameliorating colon histology, and regulating the secretion of the proinflammatory cytokines, thus reducing or inhibiting the inflammatory pathways in the colon. These results are in agreement with numerous previous reports focusing on probiotics and metformin and their beneficial effects on diabetes and CRC [29,31]. These health benefits could be due to the multiple mechanisms involved in such a mutualistic approach of probiotics and the intestinal barrier, resulting in the inhibition of the dynamics of initiation and development of IBD and CRC.…”

Section: Discussionsupporting

confidence: 93%

“…Metformin has a high oral bioavailability and its mechanisms in targeting the host for the treatment of metabolic diseases have been well studied. However, recent studies revealed that the gut microbiota might play an important role in its efficacy, shedding light on the fact that the gastrointestinal tract is a key site in the action of metformin [30,31]. Thus, the modulation of the gut microbiota may be one of the mechanisms contributing to the antidiabetic and anticarcinogenic effects of metformin.…”

Section: Introductionmentioning

confidence: 99%

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Metformin and Probiotics in the Crosstalk between Colitis-Associated Colorectal Cancer and Diabetes in Mice

Kattar

Jurjus

Pinon

et al. 2020

Cancers

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The co-occurrence of colorectal cancer (CRC) and diabetes mellitus along with inflammation and dismicrobism has been frequently reported. Several studies shed light on the antioncogenic potential of metformin on colorectal carcinogenesis. This study aimed to demonstrate that metformin in association with probiotics acts in a synergic effect in breaking the crosstalk, thus inhibiting CRC progression, improving diabetes, and reducing inflammation. Ninety-six male Balb/c mice, 6–8 weeks old, were divided into 16 control and experimental groups to assess the effect of the different treatments and combinations at the clinical, histological, and molecular levels. Metformin and probiotics showed beneficial outcomes on CRC and diabetes, alone and most importantly in combination. Their effects were exerted by inhibiting the inflammatory process whereby a downregulation of IL-6 and TNF-α as well as oxidative stress were depicted. The characterization of the effects of probiotics and metformin on CRC and diabetes sheds light on the role of inflammation and microbiota in this crosstalk. Deciphering the downstream signaling pathways elicited by these compounds will help in developing new effective targeted treatment modalities.

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Section: Discussionsupporting

confidence: 93%

Section: Introductionmentioning

confidence: 99%

Metformin and Probiotics in the Crosstalk between Colitis-Associated Colorectal Cancer and Diabetes in Mice

Kattar

Jurjus

Pinon

et al. 2020

Cancers

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“…In line with the potential probiotic impact on metabolic syndrome, multistrain probiotic formulation UB0316, containing Lpb. plantarum UBLP-40, was recently applied as therapeutic intervention in patients affected by type-2 diabetes mellitus [ 190 ] and in a weight management clinical study [ 191 ].…”

Section: Clinical Studiesmentioning

confidence: 99%

Health-Promoting Role of Lactiplantibacillus plantarum Isolated from Fermented Foods

et al. 2021

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Fermentation processes have been used for centuries for food production and preservation. Besides the contribution of fermentation to food quality, recently, scientific interest in the beneficial nature of fermented foods as a reservoir of probiotic candidates is increasing. Fermented food microbes are gaining attention for their health-promoting potential and for being genetically related to human probiotic bacteria. Among them, Lactiplantibacillus (Lpb.) plantarum strains, with a long history in the food industry as starter cultures in the production of a wide variety of fermented foods, are being investigated for their beneficial properties which are similar to those of probiotic strains, and they are also applied in clinical interventions. Food-associated Lpb. plantarum showed a good adaptation and adhesion ability in the gastro-intestinal tract and the potential to affect host health through various beneficial activities, e.g., antimicrobial, antioxidative, antigenotoxic, anti-inflammatory and immunomodulatory, in several in vitro and in vivo studies. This review provides an overview of fermented-associated Lpb. plantarum health benefits with evidence from clinical studies. Probiotic criteria that fermented-associated microbes need to fulfil are also reported.

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“…Certain findings have revealed that fatty liver disease, either alcoholic or nonalcoholic, showed alike mechanisms and pathological characteristics. Certain studies showed that the gut microbiota might play a crucial role in Met's therapeutic effect, elucidating the fact that the gastrointestinal tract (GIT) is an important site in the Met action [10][11][12]. It is even appreciable that improving the therapeutic effect of Met using gut microbiome modulators like probiotics may reduce oxidative stress and ER stress and increase the level of the anti-inflammatory cytokine.…”

Section: Introductionmentioning

confidence: 99%

Metformin and Probiotics Interplay in Amelioration of Ethanol-Induced Oxidative Stress and Inflammatory Response in an In Vitro and In Vivo Model of Hepatic Injury

Patel

Parwani

Patel

et al. 2021

Mediators of Inflammation

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Alcohol-induced liver injury implicates inflammation and oxidative stress as important mediators. Despite rigorous research, there is still no Food and Drug Administration (FDA) approved therapies for any stage of alcoholic liver disease (ALD). Interestingly, metformin (Met) and several probiotic strains possess the potential of inhibiting alcoholic liver injury. Therefore, we investigated the effectiveness of combination therapy using a mixture of eight strains of lactic acid-producing bacteria, commercialized as Visbiome® (V) and Met in preventing the ethanol-induced hepatic injury using in vitro and in vivo models. Human HepG2 cells and male Wistar rats were exposed to ethanol and simultaneously treated with probiotic V or Met alone as well as in combination. Endoplasmic reticulum (ER) stress markers, inflammatory markers, lipid metabolism, reactive oxygen species (ROS) production, and oxidative stress were evaluated, using qRT-PCR, Oil red O staining, fluorimetry, and HPLC. In vitro, probiotic V and Met in combination prevented ethanol-induced cellular injury, ER stress, oxidative stress, and regulated lipid metabolism as well as inflammatory response in HepG2 cells. Probiotic V and Met also promoted macrophage polarization towards the M2 phenotype in ethanol-exposed RAW 264.7 macrophage cells. In vivo, combined administration of probiotic V and Met ameliorated the histopathological changes, inflammatory response, hepatic markers (liver enzymes), and lipid metabolism induced by ethanol. It also improved the antioxidant markers (HO-1 and Nrf-2), as seen by their protein levels in both HepG2 cells as well as liver tissue using ELISA. Hence, probiotic V may act, in addition to the Met, as an effective preventive treatment against ethanol-induced hepatic injury.

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Efficacy of UB0316, a multi-strain probiotic formulation in patients with type 2 diabetes mellitus: A double blind, randomized, placebo controlled study

Cited by 65 publications

References 30 publications

Metformin and Probiotics in the Crosstalk between Colitis-Associated Colorectal Cancer and Diabetes in Mice

Metformin and Probiotics in the Crosstalk between Colitis-Associated Colorectal Cancer and Diabetes in Mice

Health-Promoting Role of Lactiplantibacillus plantarum Isolated from Fermented Foods

Metformin and Probiotics Interplay in Amelioration of Ethanol-Induced Oxidative Stress and Inflammatory Response in an In Vitro and In Vivo Model of Hepatic Injury

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