The effects of probiotic supplementation on biomarkers of inflammation, oxidative stress and pregnancy outcomes in gestational diabetes The effects of sodium butyrate and inulin supplementation on angiotensin signaling pathway via promotion of Akkermansia muciniphila abundance in type 2 diabetes; A randomized, double-blind, placebo-controlled trial Oral chondroitin sulfate and prebiotics for the treatment of canine Inflammatory Bowel Disease: a randomized, controlled clinical trial Effects of Probiotic Supplementation on Hormonal Profiles, Biomarkers of Inflammation and Oxidative Stress in Women With Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. The effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial The Effects of Synbiotic Supplementation on Pregnancy Outcomes in Gestational Diabetes Consumption of Bifidobacterium lactis Bi-07 by healthy elderly adults enhances phagocytic activity of monocytes and granulocytes The effects of probiotic and selenium co-supplementation on parameters of mental health, hormonal profiles, and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome Supplementation of Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 in Diet-Induced Obese Mice Is Associated with Gut Microbial Changes and Reduction in Obesity Effects of Coenzyme Q10 Supplementation on Serum Values of Gamma-glutamyl transferase, Pseudocholinesterase, Bilirubin, Ferritin, and High-Sensitivity C-Reactive Protein in Women with Type 2 Diabetes. Fighting Fatty Liver Diseases with Nutritional Interventions, Probiotics, Symbiotics, and Fecal Microbiota Transplantation (FMT). Synbiotics Easing Renal Failure by Improving Gut Microbiology (SYNERGY): A Randomized Trial. Effects of Probiotics on Biomarkers of Oxidative Stress and Inflammatory Factors in Petrochemical Workers: A Randomized, Double-blind, Placebo-controlled Trial Host-microbiome interactions in human type 2 diabetes following prebiotic fibre (galacto-oligosaccharide) intake. The Consumption of Synbiotic Bread Containing Lactobacillus sporogenes and Inulin Affects Nitric Oxide and Malondialdehyde in Patients with Type 2 Diabetes Mellitus: Randomized, Double-Blind, Placebo-Controlled Trial The Therapeutic Potential of Resistant Starch in Modulation of Insulin Resistance, Endotoxemia, Oxidative Stress and Antioxidant Biomarkers in Women with Type 2 Diabetes: A Randomized Controlled Clinical Trial Combination therapy with an angiotensin‐converting‐enzyme inhibitor and an angiotensin II receptor antagonist ameliorates microinflammation and oxidative stress in patients with diabetic nephropathy A human, double-blind, placebo-controlled, crossover trial of prebiotic, probiotic, and synbiotic supplementation: effects on luminal, inflammatory, epigenetic, and epithelial biomarkers of colorectal cancer. SYNbiotics Easing Renal failure by improving Gut microbiologY (SYNERGY): a protocol of placebo-controlled randomised cross-over trial Effect of Probiotics on Lipid Profile, Glycemic Control, Insulin Action, Oxidative Stress, and Inflammatory Markers in Patients with Type 2 Diabetes: A Clinical Trial Omega-3 fatty acid supplementation affects pregnancy outcomes in gestational diabetes: a randomized, double-blind, placebo-controlled trial Dietary Changes Involving Bifidobacterium longum and Other Nutrients Delays Chronic Kidney Disease Progression The effect of synbiotics pomegranate juice on cardiovascular risk factors in PCOS patients: a randomized, triple-blinded, controlled trial
Abstract Objective : This study was design ed to evaluate the effects of probiotic supplementation on biomarkers of inflammation , oxidative stress and pregnancy outcomes  among subjects with gestational diabetes ( GDM ) . Methods : This r and omized , double-blind , placebo-controlled clinical trial was done among 60 subjects with GDM who were not on oral hypoglycemic agents . Patients were r and omly allocated to intake either probiotic capsule containing Lactobacillus acidophilus , Lactobacillus casei and Bifidobacterium bifidum ( 2 × 109 CFU/g each ) ( n = 30 ) or placebo ( n = 30 ) for six weeks . Results : Compared with the placebo , probiotic supplementation result ed in significant decreases in fasting plasma glucose ( FPG ) ( −5.3 ± 6.7 vs. + 0.03 ± 9.0 mg/dL , p = .01 ) , serum high-sensitivity C-reactive protein ( hs-CRP ) ( −2.2 ± 2.7 vs. + 0.5 ± 2.4 μg/mL , p < .001 ) , plasma malondialdehyde ( MDA ) concentrations ( −0.1 ± 0.8 vs. + 0.5 ± 1.5 μmol/L , p = .03 ) and MDA/TAC ratio ( −0.0003 ± 0.0008 vs. + 0.0009 ± 0.002 , p = .004 ) , and a significant increase in total antioxidant capacity ( TAC ) levels ( + 65.4 ± 103.3 vs. −37.2 ± 143.7 mmol/L , p = .002 ) . Probiotic supplementation did not affect pregnancy outcomes . Conclusions : Overall , probiotic supplementation among women with GDM for six weeks had beneficial effects on FPG , serum hs-CRP , plasma TAC , MDA and oxidative stress index , but did not affect pregnancy outcomes Introduction : Inflammation has a crucial role in the progression of cardiovascular disease in diabetes . Tumour necrosis factor-α ( TNF-α ) as an inflammatory marker induces angiotensin II ( Ang II ) related hypertension pathway in diabetic patients . Gut modulation via prebiotics may ameliorate hypertension caused by inflammation . The aim of this study was to investigate the role of sodium butyrate ( NaBut ) and inulin supplements on inflammatory and oxidative stress parameters in type 2 diabetic patients . Methods : In this clinical trial , 60 overweight and obese diabetic patients were recruited and r and omly allocated into four groups . The groups received , respectively , 600 mg/d NaBut ( group A ) , 10 g/d inulin powder ( group B ) , both inulin and NaBut ( group C ) , or placebo ( group D ) for 45 consecutive days . Blood and stool sample s were collected at baseline and after intervention . Quantitative real-time PCR analysis targeting the 16S rRNA gene of Akkermansia muciniphila was done . We assessed the TNF-α mRNA expression and the serum levels of the high sensitive C-reactive protein ( hs-CRP ) and malondialdehyde ( MDA ) . Results : There was a significant increase in A. muciniphila percent change in inulin and butyrate supplemented groups ( P < 0.05 ) . Furthermore , significant decrease was seen in TNF-α mRNA expression in group A ( fold change 0.88 ± 0.16 , P < 0.05 ) , group B ( fold change 0.75 ± 0.18 , P < 0.05 ) and group C ( fold change 0.91 ± 0.32 , P < 0.05 ) . Also hs-CRP , MDA and diastolic blood pressure levels decreased significantly in these groups ( P < 0.05 ) . Conclusion : Intervention had significant effects on inflammatory and oxidative stress parameters and led to improvement of hypertension . However , further investigations are needed to make concise conclusions Background Canine inflammatory bowel disease ( IBD ) is a chronic enteropathy of unknown etiology , although microbiome dysbiosis , genetic susceptibility , and dietary and /or environmental factors are hypothesized to be involved in its pathogenesis . Since some of the current therapies are associated with severe side effects , novel therapeutic modalities are needed . A new oral supplement for long-term management of canine IBD containing chondroitin sulfate ( CS ) and prebiotics ( resistant starch , β-glucans and mannaoligosaccharides ) was developed to target intestinal inflammation and oxidative stress , and restore normobiosis , without exhibiting any side effects . This double-blinded , r and omized , placebo-controlled trial in dogs with IBD aims to evaluate the effects of 180 days administration of this supplement together with a hydrolyzed diet on clinical signs , intestinal histology , gut microbiota , and serum biomarkers of inflammation and oxidative stress . Results Twenty-seven client-owned biopsy-confirmed IBD dogs were included in the study , switched to the same hydrolyzed diet and classified into one of two groups : supplement and placebo . Initially , there were no significant differences between groups ( p > 0.05 ) for any of the studied parameters . Final data analysis ( supplement : n = 9 ; placebo : n = 10 ) showed a significant decrease in canine IBD activity index ( CIBDAI ) score in both groups after treatment ( p < 0.001 ) . After treatment , a significant decrease ( 1.53-fold ; p < 0.01 ) in histologic score was seen only in the supplement group . When groups were compared , the supplement group showed significantly higher serum cholesterol ( p < 0.05 ) and paraoxonase-1 ( PON1 ) levels after 60 days of treatment ( p < 0.01 ) , and the placebo group showed significantly reduced serum total antioxidant capacity ( TAC ) levels after 120 days ( p < 0.05 ) . No significant differences were found between groups at any time point for CIBDAI , WSAVA histologic score and fecal microbiota evaluated by PCR-restriction fragment length polymorphism ( PCR-RFLP ) . No side effects were reported in any group . Conclusions The combined administration of the supplement with hydrolyzed diet over 180 days was safe and induced improvements in selected serum biomarkers , possibly suggesting a reduction in disease activity . This study was likely underpowered , therefore larger studies are warranted in order to demonstrate a supplemental effect to dietary treatment of this supplement on intestinal histology and CIBDAI BACKGROUND To the best of our knowledge , data on effects of probiotic administration on hormonal profiles , biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome ( PCOS ) are scarce . This investigation was conducted to assess the effects of probiotic supplementation on hormonal profiles , biomarkers of inflammation and oxidative stress in women with PCOS . METHODS This r and omized , double-blind , placebo-controlled trial was conducted on 60 women with PCOS , aged 18 - 40 years old . Subjects were r and omly assigned into 2 groups to receive either probiotics or placebo ( n = 30 each group ) for 12 weeks . Metabolic profiles were quantified at baseline and after a 12-week intervention . RESULTS After the 12-week intervention , compared with placebo , probiotic supplementation significantly increased serum sex hormone-binding globulin ( SHBG ) ( + 25.9 ± 32.5 vs. + 0.5 ± 15.6 nmol/L , P < 0.001 ) and plasma total antioxidant capacity ( TAC ) ( + 8.8 ± 120.5 vs. -98.3 ± 246.4 mmol/L , P = 0.04 ) , and significantly decreased serum total testosterone ( -0.2 ± 0.7 vs. + 0.2 ± 0.6 ng/mL , P = 0.03 ) , modified Ferriman-Gallwey ( mF-G ) scores ( -1.7 ± 1.5 vs. -0.2 ± 1.0 , P < 0.001 ) , serum high-sensitivity C-reactive protein ( hs-CRP ) ( -1150.0 ± 1295.2 vs. + 202.5 ± 1426.3 ng/mL , P < 0.001 ) and plasma malondialdehyde ( MDA ) concentrations ( -0.2 ± 0.6 vs. + 0.9 ± 1.3 µmol/L , P < 0.001 ) . We did not observe any detrimental effect of probiotic supplementation on other metabolic profiles . CONCLUSION Overall , probiotic supplementation of PCOS women for 12 weeks had beneficial effects on total testosterone , SHBG , mFG scores , hs-CRP , TAC and MDA levels but did not affect other metabolic profiles Background To our knowledge , no reports are available indicating the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome ( PCOS ) . This research was done to assess the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with PCOS . Methods This r and omized double-blind , placebo-controlled trial was conducted on 60 subjects diagnosed with PCOS according to the Rotterdam criteria . Subjects were r and omly assigned into two groups to take either synbiotic ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Endocrine , inflammation and oxidative stress biomarkers were quantified at baseline and after the 12-week intervention . Results After the 12-week intervention , compared with the placebo , synbiotic supplementation significantly increased serum sex hormone-binding globulin ( SHBG ) ( changes from baseline in synbiotic group : + 19.8 ± 47.3 vs. in placebo group : + 0.5 ± 5.4 nmol/L , p = 0.01 ) , plasma nitric oxide ( NO ) ( changes from baseline in synbiotic group : + 5.5 ± 4.8 vs. in placebo group : + 0.3 ± 9.1 μmol/L , p = 0.006 ) , and decreased modified Ferriman Gallwey ( mF-G ) scores ( changes from baseline in synbiotic group : − 1.3 ± 2.5 vs. in placebo group : − 0.1 ± 0.5 , p = 0.01 ) and serum high-sensitivity C-reactive protein ( hs-CRP ) ( changes from baseline in synbiotic group : − 950.0 ± 2246.6 vs. in placebo group : + 335.3 ± 2466.9 ng/mL , p = 0.02 ) . We did not observe any significant effect of synbiotic supplementation on other hormonal status and biomarkers of oxidative stress . Conclusions Overall , synbiotic supplementation for 12 weeks in PCOS women had beneficial effects on SHBG , mFG scores , hs-CRP and NO levels , but did not affect other hormonal status and biomarkers of oxidative stress . Trial registration This study was retrospectively registered in the Iranian website ( www.i rct .ir ) for registration of clinical trials ( I RCT 201509115623N53 ) , on 2015–09 - 27 Abstract Synbiotics are known to exert multiple beneficial effects , including anti-inflammatory and antioxidative actions . This study was design ed to evaluate the effects of synbiotic administration on biomarkers of inflammation , oxidative stress , and pregnancy outcomes among gestational diabetic ( GDM ) women . This r and omized , double-blind , placebo-controlled clinical trial was carried out among 60 subjects with GDM who were not on oral hypoglycemic agents . Patients were r and omly assigned to consume either one synbiotic capsule containing Lactobacillus acidophilus strain T16 ( IBRC-M10785 ) , L. casei strain T2 ( IBRC-M10783 ) , and Bifidobacterium bifidum strain T1 ( IBRC-M10771 ) ( 2 × 109 CFU/g each ) plus 800 mg inulin ( HPX ) ( n = 30 ) or placebo ( n = 30 ) for 6 weeks . Compared with the placebo , synbiotic supplementation significantly decreased serum high-sensitivity C-reactive protein ( hs-CRP ) ( − 1.9 ± 4.2 vs. + 1.1 ± 3.5 mg/L , P = 0.004 ) , plasma malondialdehyde ( MDA ) ( − 0.1 ± 0.6 vs. + 0.3 ± 0.7 μmol/L , P = 0.02 ) , and significantly increased total antioxidant capacity ( TAC ) ( + 70.1 ± 130.9 vs. − 19.7 ± 124.6 mmol/L , P = 0.009 ) and total glutathione ( GSH ) levels ( + 28.7 ± 61.5 vs. − 14.9 ± 85.3 μmol/L , P = 0.02 ) . Supplementation with synbiotic had a significant decrease in cesarean section rate ( 16.7 vs. 40.0 % , P = 0.04 ) , lower incidence of hyperbilirubinemic newborns ( 3.3 vs. 30.0 % , P = 0.006 ) , and newborns ’ hospitalization ( 3.3 vs. 30.0 % , P = 0.006 ) compared with the placebo . Synbiotic supplementation did not affect plasma nitric oxide ( NO ) levels and other pregnancy outcomes . Overall , synbiotic supplementation among GDM women for 6 weeks had beneficial effects on serum hs-CRP , plasma TAC , GSH , and MDA ; cesarean section ; incidence of newborn ’s hyperbilirubinemia ; and newborns ’ hospitalization but did not affect plasma NO levels and other pregnancy outcomes . http://www.i rct .ir : www.i rct .ir : I RCT Elderly adults have alterations in their gut microbiota and immune functions that are associated with higher susceptibility to infections and metabolic disorders . Probiotics and prebiotics , and their synbiotic combinations are food supplements that have been shown to improve both gut and immune function . The objective of this r and omised , double-blind , placebo-controlled , cross-over human clinical trial was to study immune function and the gut microbiota in healthy elderly adults . Volunteers ( n 37 ) consumed prebiotic galacto-oligosaccharides ( GOS ; 8 g/d ) , probiotic Bifidobacterium lactis Bi-07 ( Bi-07 ; 109 colony-forming units/d ) , their combination ( Bi-07 + GOS ) and maltodextrin control ( 8 g/d ) in four 3-week periods separated by 4-week wash-out periods . Immune function was analysed by determining the phagocytic and oxidative burst activity of monocytes and granulocytes , whole-blood response to lipopolysaccharide , plasma chemokine concentrations and salivary IgA levels . Gut microbiota composition and faecal SCFA content were determined using 16S ribosomal RNA fluorescence in situ hybridisation and HPLC , respectively . Primary statistical analyses indicated the presence of carry-over effects and thus measurements from only the first supplementation period were considered valid . Subsequent statistical analysis showed that consumption of Bi-07 improved the phagocytic activity of monocytes ( P < 0·001 ) and granulocytes ( P = 0·02 ) . Other parameters were unchanged . We have for the first time shown that the probiotic Bi-07 may provide health benefits to elderly individuals by improving the phagocytic activity of monocytes and granulocytes . The present results also suggest that in the elderly , the effects of some probiotics and prebiotics may last longer than in adults Background The aim of this study was to evaluate the effect of the co-administration of probiotic and selenium on parameters of mental health , hormonal profiles , and biomarkers of inflammation and oxidative stress in women with PCOS . Data on the effects of selenium and probiotic co-supplementation on mental health , hormonal and inflammatory parameters of patients with polycystic ovary syndrome ( PCOS ) are scarce . This investigation was carried out to evaluate the effects of selenium and probiotic co-supplementation on mental health , hormonal and inflammatory parameters in women with PCOS . Methods This r and omized , double-blinded , placebo-controlled clinical trial was conducted on 60 subjects , aged 18–40 years old . Participants were r and omly allocated into two groups to intake 8 × 109 CFU/day probiotic plus 200 μg/day selenium supplements ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Hormonal and inflammatory parameters were measured at baseline and after the 12-week intervention . Results Probiotic and selenium co-supplementation result ed in a significant improvement in beck depression inventory ( β − 0.76 ; 95 % CI , − 1.26 , − 0.26 ; P = 0.003 ) , general health question naire scores ( β − 1.15 ; 95 % CI , − 1.97 , − 0.32 ; P = 0.007 ) and depression anxiety and stress scale scores ( β − 1.49 ; 95 % CI , − 2.59 , − 0.39 ; P = 0.009 ) compared with the placebo . Furthermore , probiotic and selenium co-supplementation  significantly reduced total testosterone ( β − 0.26 ng/mL ; 95 % CI , − 0.51 , − 0.02 ; P = 0.03 ) , hirsutism ( β − 0.43 ; 95 % CI , − 0.74 , − 0.11 ; P = 0.008 ) , high-sensitivity C-reactive protein ( hs-CRP ) ( β − 0.58 mg/L ; 95 % CI , − 0.97 , − 0.19 ; P = 0.004 ) and malondialdehyde ( MDA ) levels ( β − 0.29 μmol/L ; 95 % CI , − 0.56 , − 0.02 ; P = 0.03 ) , and significantly increased total antioxidant capacity ( TAC ) ( β + 84.76 mmol/L ; 95 % CI , + 48.08 , + 121.44 ; P < 0.001 ) and total glutathione ( GSH ) levels ( β + 26.78 μmol/L ; 95 % CI , + 4.33 , + 49.23 ; P = 0.02 ) compared with the placebo . Conclusions Overall , the co-administration of probiotic and selenium for 12 weeks to women with PCOS had beneficial effects on mental health parameters , serum total testosterone , hirsutism , hs-CRP , TAC , GSH and MDA levels . This study was prospect ively registered in the Iranian website ( www.i rct .ir ) for registration of clinical trials ( http://www.i rct .ir : I RCT 20170513033941N22).Trial registration I RCT 20170513033941N22 Objective To investigate the functional effects of probiotic treatment on the gut microbiota , as well as liver and adipose gene expression in diet-induced obese mice . Design Male C57BL/6J mice were fed a high-fat diet ( HFD ) for 8 weeks to induce obesity , and then r and omized to receive HFD+probiotic ( Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 , n = 9 ) or HFD+placebo ( n = 9 ) for another 10 weeks . Normal diet ( ND ) fed mice ( n = 9 ) served as non-obese controls . Results Diet-induced obese mice treated with probiotics showed reduced body weight gain and fat accumulation as well as lowered plasma insulin , leptin , total-cholesterol and liver toxicity biomarkers . A total of 151,061 pyrosequencing reads for fecal microbiota were analyzed with a mean of 6,564 , 5,274 and 4,464 reads for the ND , HFD+placebo and HFD+probiotic groups , respectively . Gut microbiota species were shared among the experimental groups despite the different diets and treatments . The diversity of the gut microbiota and its composition were significantly altered in the diet-induced obese mice and after probiotic treatment . We observed concurrent transcriptional changes in adipose tissue and the liver . In adipose tissue , pro-inflammatory genes ( TNFα , IL6 , IL1β and MCP1 ) were down-regulated in mice receiving probiotic treatment . In the liver , fatty acid oxidation-related genes ( PGC1α , CPT1 , CPT2 and ACOX1 ) were up-regulated in mice receiving probiotic treatment . Conclusions The gut microbiota of diet-induced obese mice appears to be modulated in mice  receiving probiotic treatment . Probiotic treatment might reduce diet-induced obesity and modulate genes associated with metabolism and inflammation in the liver and adipose tissue BACKGROUND Type 2 diabetes mellitus ( T2DM ) is a disease associated with increased oxidative stress which results from mitochondrial dysfunction . Coenzyme Q10 ( CoQ10 ) is an essential antioxidant for energy production in mitochondria . The purpose of this r and omized double-blind clinical trial study was to evaluate the effects of CoQ10 supplementation on serum values of gamma-glutamyl transferase ( GGT ) , pseudocholinesterase ( PchE ) , bilirubin , ferritin , and high-sensitivity c-reactive protein ( hs-CRP ) and metabolic syndrome biomarkers in women with T2DM . MATERIAL & METHODS Eighty women with T2DM enrolled in this study . Thirty six of them were r and omized in the drug group ( receiving 100 mg/day of CoQ10 ) and 44 women were r and omized in placebo group . Intervention was continued for 12 weeks . In both groups 35 subjects finished the study and were included in the analysis . Serum levels of the variables were measured before and after supplementation . RESULTS Serum values of FBS ( P=0.039 ) , HOMA-IR ( P=0.01 ) , ferritin ( P<0.001 ) , total cholesterol ( TC ) ( P=0.006 ) , LDL-C ( P=0.007 ) decreased and HDL-C ( P=0.02 ) increased significantly in the drug group after intervention . Serum levels of triglyceride ( P=0.09 ) decreased marginally in CoQ10 group . CONCLUSIONS The results of the current study had shown that after supplementation with 100 mg/day of CoQ10 for 12 weeks , serum values of FBS , HOMA-IR , TC , LDL-C and ferritin were decreased and values of HDL-C were increased in women with T2DM Pediatric obesity is rising worldwide leading the worrying phenomenon of nonalcoholic fatty liver disease ( NAFLD ) to shift into one of the most frequent causes of chronic liver illness in childhood . Occurrence of NAFLD depends on several factors such as the geographical area and the diagnostic modalities used ; overall it ranges between 3 % and 10 % of pediatric population , increasing up to 70 % in patients with metabolic comorbidities ( Manco M , Bottazzo G , DeVito R et al , J Am Coll Nutr 27:667 - 676 , 2008).Recent findings have related the intestinal microbiota to a plethora of pathological conditions , including type 2 diabetes ( T2D ) , obesity , and nonalcoholic steatohepatitis ( NASH ) . One of the emerging areas of the study is the link between liver diseases and gut microbiome , which has added new information to the underst and ing of the so-called gut-liver axis . In order to address the role of gut microbiome in NAFLD onset and progression , it is necessary to " decipher " operational codes for microbiome investigation within the context of advanced laboratory medicine to capture microbiome features and , hence , to address the function of the intestinal microbiome within the gut microbiota-liver axis . Results of these investigations have allowed the beginning of implementing the usage of probiotics and symbiotics in the medical approach of  obesity and NAFLD in adults and children . Several r and omized clinical trials ( RCTs ) have been already published on  fecal microbiota transplantation  ( FMT ) , T2D , NASH , and inflammatory bowel disease (IBD).This review proposes to describe the current state of knowledge on the ways fatty liver diseases can be addressed with nutritional interventions , probiotics , symbiotics , and FMT BACKGROUND AND OBJECTIVES The generation of key uremic nephrovascular toxins , indoxyl sulfate ( IS ) , and p-cresyl sulfate ( PCS ) , is attributed to the dysbiotic gut microbiota in CKD . The aim of our study was to evaluate whether synbiotic ( pre- and probiotic ) therapy alters the gut microbiota and reduces serum concentrations of microbiome-generated uremic toxins , IS and PCS , in patients with CKD . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Predialysis adult participants with CKD ( eGFR=10 - 30 ml/min per 1.73 m(2 ) ) were recruited between January 5 , 2013 and November 12 , 2013 to a r and omized , double-blind , placebo-controlled , crossover trial of synbiotic therapy over 6 weeks ( 4-week washout ) . The primary outcome was serum IS . Secondary outcomes included serum PCS , stool microbiota profile , eGFR , proteinuria-albuminuria , urinary kidney injury molecule-1 , serum inflammatory biomarkers ( IL-1β , IL-6 , IL-10 , and TNF-α ) , serum oxidative stress biomarkers ( F2-isoprostanes and glutathione peroxidase ) , serum LPS , patient-reported health , Gastrointestinal Symptom Score , and dietary intake . A prespecified subgroup analysis explored the effect of antibiotic use on treatment effect . RESULTS Of 37 individuals r and omized ( age = 69±10 years old ; 57 % men ; eGFR=24±8 ml/min per 1.73 m(2 ) ) , 31 completed the study .  Synbiotic therapy did not significantly reduce serum IS ( -2 μmol/L ; 95 % confidence interval [ 95 % CI ] , -5 to 1 μmol/L ) but did significantly reduce serum PCS ( -14 μmol/L ; 95 % CI , -27 to -2 μmol/L ) . Decreases in both PCS and IS concentrations were more pronounced in patients who did not receive antibiotics during the study ( n=21 ; serum PCS , -25 μmol/L ; 95 % CI , -38 to -12 μmol/L ; serum IS , -5 μmol/L ; 95 % CI , -8 to -1 μmol/L ) . Synbiotics also altered the stool microbiome , particularly with enrichment of Bifidobacterium and depletion of Ruminococcaceae . Except for an increase in albuminuria of 38 mg/24 h ( P=0.03 ) in the synbiotic arm , no changes were observed in the other secondary outcomes . CONCLUSION In patients with CKD , synbiotics did not significantly reduce serum IS but did decrease serum PCS and favorably modified the stool microbiome . Large-scale clinical trials are justified Background : The aim of the current study was to determine effects of probiotic yoghurt and multispecies probiotic capsule supplementation on biomarkers of oxidative stress and inflammatory factors in petrochemical workers . Methods : This r and omized , double-blind , placebo-controlled trial was done among petrochemical workers . Subjects were r and omly divided into three groups to receive 100 g/day probiotic yogurt ( n = 12 ) or one probiotic capsule daily ( n = 13 ) or 100 g/day conventional yogurt ( n = 10 ) for 6 weeks . The probiotic yoghurt was containing two strains of Lactobacillus acidophilus and Bifidobacterium lactis with a total of min 1 × 107 CFU . Multispecies probiotic capsule contains seven probiotic bacteria spices Actobacillus casei 3 × 103 , L. acidophilus 3 × 107 , Lactobacillus rhamnosus 7 × 109 , Lactobacillus bulgaricus 5 × 108 , Bifidobacterium breve 2 × 1010 , Bifidobacterium longum 1 × 109 and Streptococcus thermophilus 3 × 108 CFU/g . Fasting blood sample s were obtained at the beginning and end of the trial to quantify biomarkers of oxidative stress and inflammatory factors . Results : Although a significant within-group decrease in plasma protein carbonyl levels was seen in the probiotic capsule group ( 326.0 ± 308.9 vs. 251.0 ± 176.3 ng/mL , P = 0.02 ) , the changes were similar among the three groups . In addition , significant within-group decreases in plasma iso prostagl and in were observed in the probiotic supplements group ( 111.9 ± 85.4 vs. 88.0 ± 71.0 pg/mL , P = 0.003 ) and in the probiotic yogurt group ( 116.3 ± 93.0 vs. 92.0 ± 66.0 pg/mL , P = 0.02 ) , nevertheless there were no significant change among the three groups . Conclusions : Taken together , consumption of probiotic yogurt or multispecies probiotic capsule had beneficial effects on biomarkers of oxidative stress in petrochemical workers Aberrant microbiota composition and function have been linked to several pathologies , including type 2 diabetes . In animal models , prebiotics induce favourable changes in the intestinal microbiota , intestinal permeability ( IP ) and endotoxaemia , which are linked to concurrent improvement in glucose tolerance . This is the first study to investigate the link between IP , glucose tolerance and intestinal bacteria in human type 2 diabetes . In all , twenty-nine men with well-controlled type 2 diabetes were r and omised to a prebiotic ( galacto-oligosaccharide mixture ) or placebo ( maltodextrin ) supplement ( 5·5 g/d for 12 weeks ) . Intestinal microbial community structure , IP , endotoxaemia , inflammatory markers and glucose tolerance were assessed at baseline and post intervention . IP was estimated by the urinary recovery of oral 51Cr-EDTA and glucose tolerance by insulin-modified intravenous glucose tolerance test . Intestinal microbial community analysis was performed by high-throughput next-generation sequencing of 16S rRNA amplicons and quantitative PCR . Prebiotic fibre supplementation had no significant effects on clinical outcomes or bacterial abundances  compared with placebo ; however , changes in the bacterial family Veillonellaceae correlated inversely with changes in glucose response and IL-6 levels ( r -0·90 , P=0·042 for both ) following prebiotic intake . The absence of significant changes to the microbial community structure at a prebiotic dosage/length of supplementation shown to be effective in healthy individuals is an important finding . We propose that concurrent metformin treatment and the high heterogeneity of human type 2 diabetes may have played a significant role . The current study does not provide evidence for the role of prebiotics in the treatment of type 2 diabetes Objectives : To our knowledge , no reports are available indicating the effects of synbiotic bread consumption on nitric oxide ( NO ) , biomarkers of oxidative stress , and liver enzymes among patients with type 2 diabetes mellitus ( T2DM ) . This study was performed to determine the effects of the daily consumption of synbiotic bread on NO , biomarkers of oxidative stress , and liver enzymes in patients with T2DM . Methods : This r and omized , double-blind , placebo-controlled trial was performed among 81 patients with diabetes , aged 35–70 years old . After a 2-week run-in period , patients were r and omly divided into 3 groups : group A ( n = 27 ) received synbiotic bread containing viable and the heat-resistant probiotic Lactobacillus sporogenes ( 1 × 108 CFU ) and 0.07 g inulin per 1 g , group B ( n = 27 ) received probiotic bread containing Lactobacillus sporogenes ( 1 × 108 CFU ) , and group C ( n = 27 ) received control bread for 8 weeks . Patients were asked to consume the synbiotic , probiotic , or control breads 3 times a day in 40 g packages for a total of 120 g/day . Fasting blood sample s were taken at baseline and after an 8-week intervention for quantificationof related markers . Results : After 8 weeks , the consumption of synbiotic bread compared to the probiotic and control breads result ed in a significant rise in plasma NO ( 40.6 ± 34.4 vs 18.5 ± 36.2 and −0.8 ± 24.5 µmol/L , respectively , p < 0.001 ) and a significant reduction in malondialdehyde ( MDA ) levels ( −0.7 ± 0.7 vs 0.6 ± 1.7 and 0.5 ± 1.5 µmol/L , respectively , p = 0.001 ) . We did not find any significant effect of the synbiotic bread consumption on plasma total antioxidant capacity ( TAC ) , plasma glutathione ( GSH ) , catalase , serum liver enzymes , calcium , iron , magnesium levels , and blood pressure compared to the probiotic and control breads . Conclusion : In conclusion , consumption of the synbiotic bread for 8 weeks among patients with T2DM had beneficial effects on plasma NO and MDA levels ; however , it did not affect plasma TAC , GSH , catalase levels , serum liver enzymes , calcium , iron , magnesium levels , and blood pressure Aims : This trial aims to determine the effects of resistant starch ( RS ) subtype 2 ( RS2 ) on glycemic status , metabolic endotoxemia and markers of oxidative stress . Methods : A r and omized , controlled , parallel-group clinical trial group of 56 females with type 2 diabetes mellitus ( T2DM ) was divided to 2 groups . The intervention group ( n = 28 ) and control group ( n = 28 ) received 10 g/day RS2 or placebo for 8 weeks , respectively . Fasting blood sample s were taken to determine glycemic status , endotoxin , high sensitivity C-reactive protein ( hs-CRP ) , malondialdehyde ( MDA ) , total antioxidant capacity ( TAC ) , antioxidant enzymes concentrations as well as uric acid at baseline and after the intervention . Results : After 8 weeks , RS2 caused a significant decrease in the levels of MDA ( -34.10 % ) , glycosylated hemoglobin ( -9.40 % ) , insulin ( -29.36 % ) , homeostasis model of insulin resistance ( -32.85 % ) and endotoxin ( -25.00 % ) , a significant increase in TAC ( 18.10 % ) and glutathione peroxidase ( 11.60 % ) as compared with control . No significant changes were observed in fasting plasma glucose , quantitative insulin sensitivity check index , hs-CRP , superoxide dismutase , catalase and uric acid in the RS2 group as compared with the control group . Conclusion : Supplementation with RS2 may be improved glycemic status , endotoxemia and markers of oxidative stress in patients with T2DM Abstract Aims / Introduction Recent studies have pointed to the effectiveness of combination therapy with an angiotensin‐converting‐enzyme inhibitor ( ACEI ) and an angiotensin receptor blocker ( ARB ) for diabetic nephropathy . However , some controversy over this combination treatment remains and the mechanisms underlying its renoprotective effects have not been fully clarified . Therefore , we compared the renoprotective effects of imidapril ( ACEI ) and losartan ( ARB ) combination therapy with losartan monotherapy in patients with diabetic nephropathy . We also compared the anti‐inflammatory and anti‐oxidative stress effects of these two treatments . Material s and Methods A total of 32 Japanese patients with type 2 diabetes and nephropathy were enrolled . Patients were r and omized to either 100 mg/day losartan ( n = 16 ) or 50 mg/day losartan plus 5 mg/day imidapril ( n = 16 ) . We evaluated clinical parameters , serum concentrations of high‐sensitivity C‐reactive protein ( hs‐CRP ) , soluble intercellular adhesion molecule‐1 ( sICAM‐1 ) , interleukin‐18 ( IL‐18 ) and monocyte chemotactic protein‐1 ( MCP‐1 ) , and the urinary concentrations of IL‐18 , MCP‐1 and 8‐hydroxy‐2′‐deoxyguanosine ( 8‐OHdG ) at 24 and 48 weeks after starting treatment . Results Blood pressure was not significantly different between the two groups . The serum levels of hs‐CRP , sICAM‐1 and IL‐18 , as well as urinary excretion of albumin , IL‐18 and 8‐OHdG decreased significantly in the combination therapy group at 48 weeks . The percent decreases in serum IL‐18 concentrations and urinary IL‐18 and 8‐OHdG were significantly greater in the combination therapy group than in the monotherapy group . Conclusions Combination therapy with an ACEI and an ARB could be beneficial for treating diabetic nephropathy through its anti‐inflammatory and anti‐oxidative stress effects BACKGROUND Diet is an important factor in colorectal carcinogenesis ; thus , dietary supplements may have a role in colorectal cancer prevention . OBJECTIVE The objective was to establish the relative luminal , epithelial , and epigenetic consequences of prebiotic , probiotic , and synbiotic dietary supplementation in humans . DESIGN This was a r and omized , double-blind , placebo-controlled , 4-wk crossover trial of resistant starch and Bifidobacterium lactis , either alone or as a combined synbiotic preparation , in 20 human volunteers . Rectal biopsy , feces , and serum sample s were collected . The rectal mucosal endpoints were DNA methylation at 16 CpG isl and loci and LINE-1 , epithelial proliferation ( Ki67 immunohistochemistry ) , and crypt cellularity . The fecal endpoints were short-chain fatty acid concentrations , pH , ammonia , and microbiological profiles ( by denaturing gradient gel electrophoresis and sequencing ) . Serum endpoints were a panel of cytokines and high-sensitivity C-reactive protein . RESULTS Seventeen subjects completed the entire study . The synbiotic intervention fostered a significantly different fecal stream bacterial community than did either the prebiotic ( P = 0.032 ) or the probiotic ( P = 0.001 ) intervention alone , in part because of a greater proportion of patients harboring fecal Lachnospiraceae spp . These changes developed in the absence of any significant differences in fecal chemistry . There were no differences in epithelial kinetics . CONCLUSIONS This synbiotic supplementation with B. lactis and resistant starch , in the doses used , induced unique changes in fecal microflora but did not significantly alter any other fecal , serum , or epithelial variables . This trial was registered in the Australian New Zeal and Clinical Trials Registry at www.anzctr.org.au as ACTRN012606000115538 Background Emerging evidence suggests modulating the microbiota in the large bowel of patients with chronic kidney disease ( CKD ) through pre- and /probiotic supplementation may inhibit the development of key nephrovascular toxins . To date , quality intervention trials investigating this novel treatment in CKD are lacking . The aim of SYNERGY is to assess the effectiveness of synbiotics ( co-administration of pre- and probiotics ) as a potential treatment targeting the synthesis of uremic toxins , specifically , indoxyl sulphate ( IS ) and p-cresyl sulphate ( PCS ) . Methods / design Thirty-seven patients with moderate to severe CKD ( Stage IV and V , pre-dialysis ) will be recruited to a double-blind , placebo-controlled , r and omised cross-over trial . Patients will be provided with synbiotic therapy or placebo for 6 weeks , with a 4 week washout before cross-over . The primary outcome is serum IS , total and free ( unbound ) concentrations , measured using ultra-performance liquid chromatography . Secondary outcomes include serum PCS , total and free ( unbound ) concentrations ; cardiovascular risk , measured by serum lipopolysaccharides , serum trimethylamine-N-oxide ( TMAO ) and inflammation and oxidative stress markers ; kidney damage , measured by 24 hour proteinuria and albuminuria , estimated glomerular filtration rate and renal tubule damage ( urinary kidney injury molecule-1 ) ; patients ’ self assessed quality of life ; and gastrointestinal symptoms . In addition , the effects on the community structure of the stool microbiota will be explored in a subset of patients to vali date the mechanistic rationale underpinning the synbiotic therapy . Discussion IS and PCS are two novel uremic toxins implicated in both cardiovascular disease ( CVD ) and progression of CKD . Preliminary studies indicate that synbiotic therapy maybe a promising strategy when considering a targeted , tolerable and cost-efficient therapy for lowering serum IS and PCS concentrations . This trial will provide high quality ‘ proof-of-concept ’ data to eluci date both the efficacy of synbiotic therapy for lowering the toxins and whether reductions in serum IS and PCS translate into clinical benefits . Considering the potential of pre- and probiotics to not only shift toxin levels , but to also impede CVD and CKD progression , SYNERGY will provide vital insight into the effectiveness of this innocuous nutritional therapy . Trial Registration Universal Trial Number : U1111 - 1142 - 4363 . Australian New Zeal and Clinical Trials Registry Number : ACTRN12613000493741 , date registered : 2nd May 2013 Background : The dramatic increase in the incidence of diabetes and its associated complications require a natural and safe solution to control and delay such complications . The present study tested the hypothesis that probiotics may affect biochemical indices of diabetic patients Methods : Thirty four types 2 diabetic patients aged between 25 to 65 years , and diagnosed with diabetes for less than 15 years were selected for this single- blinded clinical trial . Using balanced block r and om sampling , the patients were divided into two groups of intervention ( probiotics ) and placebo . Blood sample s tested for baseline glucose , insulin , TG , total cholesterol , LDL-C , HDL-C , malondialdehyde , high sensitive CRP ( hs-CRP ) and IL-6 . After six weeks of experiment , fasting blood sample s were re-tested and the data obtained were analyzed using SPSS software . Results : There were no significant differences between anthropometric data including body mass index and waist to hip ratio in placebo and treatment groups . There was no significant difference in FBS , Serum TG concentration total cholesterol and LDL-C levels between placebo and treatment groups . HDL-C levels were slightly elevated after probiotic treatment , which were not statistically significant . Insulin , MDA and IL-6 levels were reduced and high sensitive CRP hs . CRP levels were elevated , although , not statistically significant . Conclusion : The result of this study indicates a non- significant declining trend in the level of TG , MDA and IL-6 and insulin resistance after consumption of probiotics Abstract Objective : This study was design ed to assess the effects of omega-3 fatty acid supplementation on inflammatory factors , biomarkers of oxidative stress , and pregnancy outcomes among pregnant women with gestational diabetes ( GDM ) . Methods : This r and omized , double-blind , placebo-controlled clinical trial was performed among 56 women with GDM . Subjects were r and omly selected to receive either 1000 mg omega-3 fatty acid supplements ( containing 180 mg eicosapentaenoic acid and 120 mg docosahexanoic acid ) ( n = 27 ) or a placebo ( n = 27 ) for 6 weeks . Fasting blood sample s were taken at study baseline and after 6 weeks of intervention to quantify biochemical variables . Newborn ’s weight , height , head circumference , Apgar score , and hyperbilirubinemia were determined . Results : At the end of the 6 weeks , taking omega-3 fatty acid significantly decreased serum high-sensitivity C-reactive protein ( hs-CRP ) ( change from baseline : −245.1 ± 1570.5 versus + 913.9 ± 2329.4 ng/mL , p = 0.03 ) and plasma malondialdehyde ( MDA ) concentrations ( −0.4 ± 1.3 versus + 0.6±2.3 , p = 0.04 ) compared with the placebo . Supplementation with omega-3 had a low incidence of hyperbilirubinemiain newborns ( 7.7 % versus 33.3 % , p = 0.02 ) and decreased newborns ’ hospitalization rate ( 7.7 % versus 33.3 % , p = 0.02 ) . Conclusions : Taken together , omega-3 fatty acid supplementation  in GDM women had beneficial effects on maternal serum hs-CRP , plasma MDA levels , incidence of newborn ’s hyperbilirubinemia , and hospitalization Background : Recent studies suggest that prebiotic and /or probiotic treatments ameliorate kidney function in humans and animals by improving the gut environment . However , the gut microbiota and kidney disease interactions remain to be determined . This study investigated whether synbiotics modulate the gut microbiota and ameliorate kidney function using a rat model of chronic kidney disease ( CKD ) . As uremic toxins are associated with CKD-related mineral and bone disorder , the secondary aim was to evaluate the relationship between synbiotics and secondary hyperparathyroidism ( SHPT ) . Methods : 5/6 nephrectomy ( Nx ) rats were developed as the CKD model . Sham-operated ( sham ) rats were used as the control . To investigate the effectiveness of prebiotics ( glutamine , dietary fiber , and oligosaccharide ) and probiotics ( Bifidobacterium longum strain ; GFOB diet ) , rats were r and omly assigned to 4 groups : Nx group fed the GFOB diet ( n = 10 ) ; Nx group fed the control ( CON ) diet ( n = 10 ) ; sham group fed the GFOB diet ( n = 5 ) ; and sham group fed the control diet ( n = 5 ) . Blood , feces , and kidney sample s were collected and analyzed . Results : Serum creatinine ( Cre ) and blood urea nitrogen in the Nx GFOB group were significantly lower than those in the Nx CON group . Serum indoxyl sulfate in the Nx GFOB group was lower than that in the Nx CON group , and significantly correlated with serum Cre . Inorganic phosphorus and intact parathyroid hormone in the Nx GFOB group were significantly lower than those in the Nx CON group . Conclusion : Improving the gut environment using synbiotics ameliorated kidney function and might be a pharmacological treatment for SHPT without any serious adverse events Purpose Polycystic ovarian syndrome ( PCOS ) is one of the most common metabolic and endocrine disorders . Functional foods like pomegranate and probiotics are those that are considered to have beneficial effects on metabolic diseases beyond their basic nutritional value . So , we aim ed to evaluate the effect of synbiotic pomegranate juice ( SPJ ) on cardiovascular risk factors on PCOS patients . Methods This was a r and omized , triple-blinded , 8-week trial . Participants were r and omly assigned to receive 300 mL/day of pomegranate juice ( PJ ) , synbiotic beverage ( SB ) , synbiotic pomegranate juice ( SPJ ) , or placebo beverage ( PB ) . Biochemical indices ( lipid profile , Total Antioxidant Capacity ( TAC ) , Malondialdehyde ( MDA ) , high sensitive C-Reactive Protein ( hs-CRP ) ) and blood pressure were assessed before and after the intervention . Results Participants in the PJ , SB , and SPJ groups experienced improvement in their lipid profile , oxidative stress , inflammation , and blood pressure during the time . Compared to placebo , Total Cholesterol ( TC ) was lower in the SB group ( P < 0.01 ) , LDL-c was lower in the SPJ and SB groups ( P < 0.01 ) , and HDL-c was higher in the SPJ and PJ groups ( P < 0.01 ) . With regards to oxidative stress and inflammation , when compared with placebo , MDA was lower in the SPJ , SB , and PJ groups ( P < 0.001 ) , TAC was increased in the SPJ and PJ groups ( P $ $ < $ $ < 0.001 ) , and hs-CRP was decreased in the PJ group ( P = 0.02 ) . Blood pressure ( BP ) was lower in the SPJ and PJ groups compared to placebo ( P < 0.001 ; P < 0.01 , respectively ) . Conclusions Consuming daily SPJ for 8 weeks improved metabolic , oxidative , inflammatory , and BP outcomes in females with PCOS . This trial was registered in the Iranian Registry of Clinical Trials ( I RCT 20170207032439N2 )
The results of this systematic review and meta‐ analysis suggest that probiotic and synbiotic supplementation may help to improve biomarkers of inflammation and oxidative stress in diabetic patients .
Abstract The role of gut microbiota in the management of diabetes has been shown .
Several current trials are investigating the effect of probiotics and prebiotics , which are widely used to modulate intestinal microbiota , on inflammatory factors and biomarkers of oxidative stress in diabetic patients ; however , their findings are controversial .
The aim of the current meta‐ analysis was to evaluate the effects of probiotic and synbiotic supplementation on levels of serum high‐sensitivity C‐reactive protein ( hs‐CRP ) and biomarkers of oxidative stress in diabetic patients .