Is there a value for probiotic supplements in gestational diabetes mellitus? A randomized clinical trial Probiotics for the Prevention of Gestational Diabetes Mellitus in Overweight and Obese Women: Findings From the SPRING Double-Blind Randomized Controlled Trial Effects of probiotic supplementation on glycaemic control and lipid profiles in gestational diabetes: A randomized, double-blind, placebo-controlled trial. The effects of probiotic supplementation on biomarkers of inflammation, oxidative stress and pregnancy outcomes in gestational diabetes Effects of probiotic supplements on insulin resistance in gestational diabetes mellitus: A double‐blind randomized controlled trial Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial Effects of a Multispecies Probiotic Mixture on Glycemic Control and Inflammatory Status in Women with Gestational Diabetes: A Randomized Controlled Clinical Trial SPRING: an RCT study of probiotics in the prevention of gestational diabetes mellitus in overweight and obese women Probiotics in obese pregnancy do not reduce maternal fasting glucose: a double-blind, placebo-controlled, randomized trial (Probiotics in Pregnancy Study). Effects of probiotics in patients with diabetes mellitus type 2: study protocol for a randomized, double-blind, placebo-controlled trial Connections between the human gut microbiome and gestational diabetes mellitus Impact of maternal probiotic-supplemented dietary counselling on pregnancy outcome and prenatal and postnatal growth: a double-blind, placebo-controlled study. Early pregnancy probiotic supplementation with Lactobacillus rhamnosus HN001 may reduce the prevalence of gestational diabetes mellitus: a randomised controlled trial The Effects of Synbiotic Supplementation on Pregnancy Outcomes in Gestational Diabetes Probiotics and dietary counselling contribute to glucose regulation during and after pregnancy: a randomised controlled trial. Effect of alive probiotic on insulin resistance in type 2 diabetes patients: Randomized clinical trial. Transglucosidase improves the gut microbiota profile of type 2 diabetes mellitus patients: a randomized double-blind, placebo-controlled study
Background Although several studies have found probiotics encouraging in prevention of gestational diabetes mellitus ( GDM ) , the evidence for the use of probiotics in diagnosed GDM is largely limited . The aim of this study was to assess the effect of a probiotic supplement capsule containing four bacterial strains on glucose metabolism indices and weight changes in women with newly diagnosed GDM . Methods Sixty-four pregnant women with GDM were enrolled into a double-blind placebo-controlled r and omized clinical trial . They were r and omly assigned to receive either a probiotic or placebo capsule along with dietary advice for eight consecutive weeks . The trend of weight gain along with glucose metabolism indices was assayed . Results During the first 6 weeks of the study , the weight gain trend was similar between the groups . However , in the last 2 weeks of the study , the weight gain in the probiotic group was significantly lower than in the placebo group ( p < 0.05 ) . Fasting blood sugar ( FBS ) decreased in both intervention ( from 103.7 to 88.4 mg/dl ) and control ( from 100.9 to 93.6 mg/dl ) groups significantly , and the decrease in the probiotic group was significantly higher than in the placebo group ( p < 0.05 ) . Insulin resistance index in the probiotic group had 6.74 % reduction over the study period ( p < 0.05 ) . In the placebo group , however , there was an increase in insulin resistance index ( 6.45 % ) , but the observed change in insulin resistance was not statistically significant . Insulin sensitivity index was increased in both groups . The post-intervention insulin sensitivity index in the probiotic group was not significantly different from placebo when adjusted for the baseline levels . Conclusions The probiotic supplement appeared to affect glucose metabolism and weight gain among pregnant women with GDM . This needs to be confirmed in other setting s before a therapeutic value could be approved OBJECTIVE Given the role of gut microbiota in regulating metabolism , probiotics administered during pregnancy might prevent gestational diabetes mellitus ( GDM ) . This question has not previously been studied in high-risk overweight and obese pregnant women . We aim ed to determine whether probiotics ( Lactobacillus rhamnosus and Bifidobacterium animalis subspecies lactis ) administered from the second trimester in overweight and obese women prevent GDM as assessed by an oral glucose tolerance test ( OGTT ) at 28 weeks ’ gestation . Secondary outcomes included maternal and neonatal complications , maternal blood pressure and BMI , and infant body composition . RESEARCH DESIGN AND METHODS This was a double-blind r and omized controlled trial of probiotic versus placebo in overweight and obese pregnant women in Brisbane , Australia . RESULTS The study was completed in 411 women .  GDM occurred in 12.3 % ( 25 of 204 ) in the placebo arm and 18.4 % ( 38 of 207 ) in the probiotics arm ( P = 0.10 ) . At OGTT , mean fasting glucose was higher in women r and omized to probiotics ( 79.3 mg/dL ) compared with placebo ( 77.5 mg/dL ) ( P = 0.049 ) . One- and two-hour glucose measures were similar . Preeclampsia occurred in 9.2 % of women r and omized to probiotics compared with 4.9 % in the placebo arm ( P = 0.09 ) . Excessive weight gain occurred in 32.5 % of women in the probiotics arm ( 55 of 169 ) compared with 46 % in the placebo arm ( 81 of 176 ) ( P = 0.01 ) . Rates of small for gestational age ( < 10th percentile ) were 2.4 % in the probiotics arm ( 5 of 205 ) and 6.5 % in the placebo arm ( 13 of 199 ) ( P = 0.042 ) . There were no differences in other secondary outcomes . CONCLUSIONS The probiotics used in this study did not prevent GDM in overweight and obese pregnant women BACKGROUND To our knowledge , data on the effects of probiotic supplementation on glycaemic control and lipid concentrations in patients with gestational diabetes mellitus ( GDM ) are scarce . AIM The aim of the present study was to determine the effects of probiotic supplementation on glycaemic control and lipid profiles in GDM patients . METHODS Sixty pregnant women with GDM , primigravida and aged 18 - 40years , were divided into two groups to receive either probiotic capsules ( n=30 ) or a matching placebo ( n=30 ) in this r and omized double-blind , placebo-controlled trial . The patients in the probiotic group took a daily capsule that contained three viable freeze-dried strains : Lactobacillus acidophilus ( 2 × 10(9)CFU/g ) , L. casei ( 2 × 10(9)CFU/g ) and Bifidobacterium bifidum ( 2 × 10(9)CFU/g ) for 6weeks . The placebo group took capsules filled with cellulose for the same time period . Fasting blood sample s were taken at the beginning and end of the study to quantify the relevant markers . RESULTS After 6weeks of intervention , probiotic supplementation vs a placebo result ed in significant decreases in fasting plasma glucose ( -9.2±9.2mg/dL vs + 1.1±12.2mg/dL , P<0.001 ) , serum insulin levels ( -0.8±3.1μIU/mL vs + 4.5±10.6μIU/mL , P=0.01 ) , homoeostasis model assessment ( HOMA ) for insulin resistance ( -0.4±0.9 vs + 1.1±2.5 , P=0.003 ) and HOMA for β-cell function ( + 1.1±9.8 vs + 18.0±42.5 , P=0.03 ) , and a significant increase in the quantitative insulin sensitivity check index ( + 0.007±0.01 vs -0.01±0.02 , P=0.007 ) . In addition , significant decreases in serum triglycerides ( -1.6±59.4mg/dL vs + 27.1±37.9mg/dL , P=0.03 ) and VLDL cholesterol concentrations ( -0.3±11.9mg/dL vs + 5.4±7.6mg/dL , P=0.03 ) were seen following supplementation with the probiotics compared with the placebo . However , no significant changes in other lipid profiles were seen with the intervention . CONCLUSION Overall , the results of our study have demonstrated that taking probiotic supplements for 6weeks in patients with GDM had beneficial effects on glycaemic control , triglycerides and VLDL cholesterol concentrations , although there was no effect on other lipid profiles 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 Abstract Aims / Introduction To evaluate the effect of probiotic supplements on insulin resistance in pregnant women with diet‐controlled gestational diabetes mellitus . Material s and Methods A r and omized , double‐blind , placebo‐controlled trial was carried out between June 2016 and February 2017 . Pregnant women with diet‐controlled gestational diabetes mellitus were enrolled in the study at 24–28 weeks‐of‐gestation and r and omized to receive either probiotic supplements containing Bifidobacterium and Lactobacillus or a placebo daily for four consecutive weeks . Primary outcomes were mean differences in insulin resistance ( homeostatic model assessment for insulin resistance ) , fasting insulin and fasting plasma glucose between the two groups . Secondary outcomes were changes in maternal weight after the intervention . Results Data from 28 patients in the probiotic group and 29 in the placebo group were analyzed . The changes in metabolic parameters after r and omization showed significant improvement in glucose metabolism in the probiotic group compared with the placebo group , including fasting plasma glucose ( 0.68 ± 5.88 vs 4.620 ± 7.78 mg/dL , mean difference −3.94 mg/dL , 95 % confidence interval −7.62 , −0.27 , P = 0.034 ) , fasting plasma insulin ( 1.11 ± 1.71 vs 3.77 ± 1.70 mIU/L , mean difference −2.67 mIU/L , 95 % confidence interval −3.57 , −1.76 , P = 0.001 ) and homeostatic model assessment for insulin resistance ( 0.25 ± 0.37 vs 0.89 ± 0.46 , mean difference −0.63 , 95 % confidence interval −0.86 , −0.41 , P = 0.001 ) . Weight gain during r and omization was similar between the two groups . Conclusions Four weeks of probiotic supplements  in women with diet‐controlled gestational diabetes in the late second and early third trimester lowered fasting glucose and increased insulin sensitivity  . Probiotic supplements may be considered as an adjunct treatment for glycemic control in these patients Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing . However , the effect of multi-strain probiotics in people with type 2 diabetes remains unclear . This study investigated the effect of multi-strain microbial cell preparation — also refers to multi-strain probiotics — on glycemic control and other diabetes-related outcomes in people with type 2 diabetes . Design A r and omized , double-blind , parallel-group , controlled clinical trial . Setting Diabetes clinic of a teaching hospital in Kuala Lumpur , Malaysia . Participants A total of 136 participants with type 2 diabetes , aged 30–70 years , were recruited and r and omly assigned to receive either probiotics ( n = 68 ) or placebo ( n = 68 ) for 12 weeks . Outcomes Primary outcomes were glycemic control-related parameters , and secondary outcomes were anthropomorphic variables , lipid profile , blood pressure and high-sensitivity C-reactive protein . The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract . Statistical analysis Intention-to-treat ( ITT ) analysis was performed on all participants , while per- protocol ( PP ) analysis was performed on those participants who had successfully completed the trial with good compliance rate . Results With respect to primary outcomes , glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis ( p < 0.05 , small effect size of 0.050 ) , while these changes were not significant in ITT analysis . Fasting insulin increased by 1.8 µU/mL in placebo group and decreased by 2.9 µU/mL in probiotics group in PP analysis . These changes were significant between groups at both analyses ( p < 0.05 , medium effect size of 0.062 in PP analysis and small effect size of 0.033 in ITT analysis ) . Secondary outcomes did not change  significantly . Probiotics successfully passed through the gastrointestinal tract . Conclusion Probiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes Objective . This trial aims to examine the effects of a Probiotic Mixture ( VSL#3 ) on glycemic status and inflammatory markers , in women with GDM . Material s and Methods . Over a period of 8 weeks , 82 women with gestational diabetes were r and omly assigned to either an intervention group ( n = 41 ) which were given VSL#3 capsule or to a control group which were given placebo capsule ( n = 41 ) . Fasting plasma glucose , homeostatic model assessment of insulin resistance , glycosylated hemoglobin , high-sensitivity C-reactive protein , tumor necrosis factor-α , interleukin-6 , Interferon gamma , and interleukin-10 were measured before and after the intervention . Results . After 8 wk of supplementation FPG , HbA1c , HOMA-IR , and insulin levels remained unchanged in the probiotic and placebo groups . The comparison between the two groups showed no significant differences with FPG and HbA1c , but there were significant differences in insulin levels and HOMA-IR ( 16.6 ± 5.9 ; 3.7 ± 1.5 , resp . ) . Unlike the levels of IFN-g ( 19.21 ± 16.6 ) , there was a significant decrease in levels of IL-6 ( 3.81 ± 0.7 ) , TNF-α ( 3.10 ± 1.1 ) , and hs-CRP ( 4927.4 ± 924.6 ) . No significant increase was observed in IL-10 ( 3.11 ± 5.7 ) in the intervention group as compared with the control group . Conclusions . In women with GDM , supplementation with probiotics ( VSL#3 ) may help to modulate some inflammatory markers and may have benefits on glycemic control Background Obesity is increasing in the child-bearing population as are the rates of gestational diabetes . Gestational diabetes is associated with higher rates of Cesarean Section for the mother and increased risks of macrosomia , higher body fat mass , respiratory distress and hypoglycemia for the infant . Prevention of gestational diabetes through life style intervention has proven to be difficult . A Finnish study showed that ingestion of specific probiotics altered the composition of the gut microbiome and thereby metabolism from early gestation and decreased rates of gestational diabetes in normal weight women . In SPRING ( the Study of Probiotics IN the prevention of Gestational diabetes ) , the effectiveness of probiotics ingestion for the prevention of gestational diabetes will be assessed in overweight and obese women . Methods / design SPRING is a multi-center , prospect i ve , double-blind r and omized controlled trial run at two tertiary maternity hospitals in Brisbane , Australia . Five hundred and forty ( 540 ) women with a BMI > 25.0 kg/m2 will be recruited over 2 years and receive either probiotics or placebo capsules from 16 weeks gestation until delivery . The probiotics capsules contain > 1x109 cfu each of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12 per capsule . The primary outcome is diagnosis of gestational diabetes at 28 weeks gestation . Secondary outcomes include rates of other pregnancy complications , gestational weight gain , mode of delivery , change in gut microbiome , preterm birth , macrosomia , and infant body composition . The trial has 80 % power at a 5 % 2-sided significance level to detect a > 50 % change in the rates of gestational diabetes in this high-risk group of pregnant women . Discussion SPRING will show if probiotics can be used as an easily implementable method of preventing gestational diabetes in the high-risk group of overweight and obese pregnant women BACKGROUND Recent studies have reported beneficial effects of probiotics on maternal glycemia in healthy pregnant women . Obesity significantly increases risk of impaired glucose tolerance in pregnancy , but glycemic effects of probiotics in this specific obstetric group require additional investigation . OBJECTIVE The aim of the Probiotics in Pregnancy Study was to investigate the effect of a probiotic capsule on maternal fasting glucose in obese pregnant women . DESIGN In this placebo-controlled , double-blind , r and omized trial , 175 pregnant women with an early pregnancy body mass index ( BMI ; in kg/m² ) from 30.0 to 39.9 were recruited from antenatal clinics at the National Maternity Hospital , Dublin , Irel and . Exclusion criteria were BMI < 30.0 or > 39.9 , prepregnancy or gestational diabetes , age < 18 y , multiple pregnancy , and fetal anomaly . Women were r and omly assigned to receive either a daily probiotic or a placebo capsule from 24 to 28 wk of gestation in addition to routine antenatal care . The primary outcome was the change in fasting glucose between groups from preintervention to postintervention . Secondary outcomes were the incidence of gestational diabetes and neonatal anthropometric measures . RESULTS In 138 women who completed the study ( 63 women in the probiotic group ; 75 women in the placebo group ) , mean ( ±SD ) early pregnancy BMI was 33.6 ± 2.6 , which differed significantly between probiotic ( 32.9 ± 2.4 ) and placebo ( 34.1 ± 2.7 ) groups . With adjustment for BMI , the change in maternal fasting glucose did not differ significantly between treated and control groups [ -0.09 ± 0.27 compared with -0.07 ± 0.39 mmol/L ; P = 0.391 ; B = -0.05 ( 95 % CI : -0.17 , 0.07 ) ] . There were also no differences in the incidence of impaired glycemia ( 16 % in the probiotic group compared with 15 % in the placebo group ; P = 0.561 ) , birth weight ( 3.70 kg in the probiotic group compared with 3.68 kg in the placebo group ; P = 0.723 ) , or other metabolic variables or pregnancy outcomes . A secondary analysis of 110 women , excluding antibiotic users and poor compliers , also revealed no differences in maternal glucose or other outcomes between groups . CONCLUSION Probiotic treatment of 4 wk during pregnancy did not influence maternal fasting glucose , the metabolic profile , or pregnancy outcomes in obese women 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 ( naïve or newly diagnosed and without co-morbidities ) will be enrolled in this clinical trial and r and omized 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 sample s analyzed . Measurements / sample s 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 Clinical Trials.gov Identifier : Abstract The human gut microbiome can modulate metabolic health and affect insulin resistance , and it may play an important role in the etiology of gestational diabetes mellitus ( GDM ) . Here , we compared the gut microbial composition of 43 GDM patients and 81 healthy pregnant women via whole-metagenome shotgun sequencing of their fecal sample s , collected at 21–29 weeks , to explore associations between GDM and the composition of microbial taxonomic units and functional genes . A metagenome-wide association study identified 154 837 genes , which clustered into 129 metagenome linkage groups ( MLGs ) for species description , with significant relative abundance differences between the 2 cohorts . Parabacteroides distasonis , Klebsiella variicola , etc . , were enriched in GDM patients , whereas Methanobrevibacter smithii , Alistipes spp . , Bifidobacterium spp . , and Eubacterium spp . were enriched in controls . The ratios of the gross abundances of GDM-enriched MLGs to control-enriched MLGs were positively correlated with blood glucose levels . A r and om forest model shows that fecal MLGs have excellent discriminatory power to predict GDM status . Our study discovered novel relationships between the gut microbiome and GDM status and suggests that changes in microbial composition may potentially be used to identify individuals at risk for GDM The perinatal nutritional environment impacts upon the health and well-being of mother and child also in the long term . The aim of the present study was to determine the safety and efficacy of perinatal probiotic-supplemented dietary counselling by evaluating pregnancy outcome and fetal and infant growth during the 24 months ' follow-up . Altogether , 256 women were r and omised at their first trimester of pregnancy into a control and a dietary intervention group . The intervention group received intensive dietary counselling provided by a nutritionist and were further r and omised , double-blind to receive probiotics ( Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 ; diet/probiotics ) or placebo ( diet/placebo ) . Firstly , probiotic intervention reduced the frequency of gestational diabetes mellitus ( GDM ) ; 13 % ( diet/probiotics ) v. 36 % ( diet/placebo ) and 34 % ( control ) ; P = 0.003 . Secondly , the safety of this approach was attested by normal duration of pregnancies with no adverse events in mothers or children . No significant differences in prenatal or postnatal growth rates among the study groups were detected . Thirdly , distinctive effects of the two interventions were detected ; probiotic intervention reduced the risk of GDM and dietary intervention diminished the risk of larger birth size in affected cases ; P = 0.035 for birth weight and P = 0.028 for birth length . The results of the present study show that probiotic-supplemented perinatal dietary counselling could be a safe and cost-effective tool in addressing the metabolic epidemic . In view of the fact that birth size is a risk marker for later obesity , the present results are of significance for public health in demonstrating that this risk is modifiable The study aims to assess whether supplementation with the probiotic Lactobacillus rhamnosus HN001 ( HN001 ) can reduce the  prevalence of gestational diabetes mellitus ( GDM ) . A double-blind , r and omised , placebo-controlled parallel trial was conducted in New Zeal and ( NZ ) ( Wellington and Auckl and ) . Pregnant women with a personal or partner history of atopic disease were r and omised at 14–16 weeks ’ gestation to receive HN001 ( 6 × 109 colony-forming units ) ( n 212 ) or placebo ( n 211 ) daily . GDM at 24–30 weeks was assessed using the definition of the International Association of Diabetes and Pregnancy Study Groups ( IADPSG ) ( fasting plasma glucose ≥5·1 mmol/l , or 1 h post 75 g glucose level at ≥10 mmol/l or at 2 h ≥8·5 mmol/l ) and NZ definition ( fasting plasma glucose ≥5·5 mmol/l or 2 h post 75 g glucose at ≥9 mmol/l ) . All analyses were intention-to-treat . A total of 184 ( 87 % ) women took HN001 and 189 ( 90 % ) women took placebo .  There was a trend towards lower relative rates ( RR ) of GDM ( IADPSG definition ) in the HN001 group , 0·59 ( 95 % CI 0·32 , 1·08 ) ( P=0·08 ) . HN001 was associated with lower rates of GDM in women aged ≥35 years ( RR 0·31 ; 95 % CI 0·12 , 0·81 , P=0·009 ) and women with a history of GDM ( RR 0·00 ; 95 % CI 0·00 , 0·66 , P=0·004 ) . These rates did not differ significantly from those of women without these characteristics . Using the NZ definition , GDM prevalence was significantly lower in the HN001 group , 2·1 % ( 95 % CI 0·6 , 5·2 ) , v. 6·5 % ( 95 % CI 3·5 , 10·9 ) in the placebo group ( P=0·03 ) . HN001 supplementation from 14 to 16 weeks ’ gestation may reduce GDM prevalence , particularly among older women and those with previous GDM 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 Balanced glucose metabolism ensures optimal fetal growth with long-term health implication s conferred on both mother and child . We examined whether supplementation of probiotics with dietary counselling affects glucose metabolism in normoglycaemic pregnant women . At the first trimester of pregnancy 256 women were r and omised to receive nutrition counselling to modify dietary intake according to current recommendations or as controls ; the dietary intervention group was further r and omised to receive probiotics ( Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 ; diet/probiotics ) or placebo ( diet/placebo ) in a double-blind manner , whilst the control group received placebo ( control/placebo ) . Blood glucose concentrations were lowest in the diet/probiotics group during pregnancy ( baseline-adjusted means 4.45 , 4.60 and 4.56 mmol/l in diet/probiotics , diet/placebo and control/placebo , respectively ; P = 0.025 ) and over the 12 months ' postpartum period ( baseline-adjusted means 4.87 , 5.01 and 5.02 mmol/l ; P = 0.025 ) . Better glucose tolerance in the diet/probiotics group was confirmed by a reduced risk of elevated glucose concentration compared with the control/placebo group ( OR 0.31 ( 95 % CI 0.12 , 0.78 ) ; P = 0.013 ) as well as by the lowest insulin concentration ( adjusted means 7.55 , 9.32 and 9.27 mU/l ; P = 0.032 ) and homeostasis model assessment ( adjusted means 1.49 , 1.90 and 1.88 ; P = 0.028 ) and the highest quantitative insulin sensitivity check index ( adjusted means 0.37 , 0.35 and 0.35 ; P = 0.028 ) during the last trimester of pregnancy . The effects observed extended over the 12-month postpartum period . The present study demonstrated that improved blood glucose control can be achieved by dietary counselling with probiotics even in a normoglycaemic population and thus may provide potential novel means for the prophylactic and therapeutic management of glucose disorders BACKGROUND Probiotics have beneficial effect on obesity related disorders in animal models . Despite a large number of animal data , r and omized placebo-controlled trials ( RCT ) concluded that probiotics have a moderate effect on glycemic control-related parameters . However , effect of probiotics on insulin resistance are inconsistent . AIM In a double-blind single center RCT , effect of alive multistrain probiotic vs. placebo on insulin resistance in type 2 diabetes patient were assessed . METHODS A total of 53 patients met the criteria for inclusion . They were r and omly assigned to receive multiprobiotic " Symbiter " ( concentrated biomass of 14 probiotic bacteria genera Bifidobacterium , Lactobacillus , Lactococcus , Propionibacterium ) or placebo for 8-weeks administered as a sachet formulation . The primary main outcome was the change HOMA-IR ( homeostasis model assessment -estimated insulin resistance ) which calculated using Matthews et al. 's equation . Secondary outcomes were the changes in glycemic control-related parameters , anthropomorphic variables and cytokines . RESULTS Supplementation with alive multiprobiotic for 8 weeks was associated with significant reduction of HOMA-IR from 6.85 ± 0.76 to 5.13 ± 0.49 ( p = 0.047 ) , but remained static in the placebo group . With respect to our secondary outcomes , HbA1c insignificant decreased by 0.09 % ( p = 0.383 ) and 0.24 % ( p = 0.068 ) respectively in placebo and probiotics groups . However , in probiotic responders ( n = 22 , patient with decrease in HOMA-IR ) after supplementation a significant reduction in HbA1c by 0.39 % ( p = 0.022 ) as compared to non-responders was observed . In addition , from markers of chronic systemic inflammatory state only TNF-α and IL-1β changes significantly after treatment with probiotics . CONCLUSION Probiotic therapies modestly improved insulin resistance in patients with type 2 diabetes Background Recently , the relationship between gut microbiota and obesity has been highlighted . The present r and omized , double-blind , placebo-controlled study aim ed to evaluate the efficacy of transglucosidase ( TGD ) in modulating blood glucose levels and body weight gain in patients with type 2 diabetes mellitus ( T2DM ) and to clarify the underlying mechanism by analyzing the gut microbiota of T2DM patients . Methods This study included 60 patients who received placebo or TGD orally ( 300 or 900 mg/day ) for 12 weeks , and blood and fecal sample s were collected before and after 12 weeks . Comparisons of fecal bacterial communities were performed before and after the TGD treatment and were performed between T2DM patients and 10 healthy individuals , using the terminal-restriction fragment length polymorphism analysis . Results The Clostridium cluster IV and subcluster XIVa components were significantly decreased , whereas the Lactobacillales and Bifidobacterium population s significantly increased in the T2DM patients compared with the healthy individuals . By dendrogram analysis , most of the healthy individuals ( 6/10 ) and T2DM patients ( 45/60 ) were classified into cluster I , indicating no significant difference in fecal bacterial communities between the healthy individuals and the T2DM patients . In the placebo and TGD groups , the bacterial communities were generally similar before and after the treatment . However , after 12 weeks of TGD therapy , the Bacteroidetes-to-Firmicutes ratio in the  TGD groups significantly increased and was significantly higher compared with that in the placebo group , indicating that TGD improved the growth of the fecal bacterial communities in the T2DM patients . Conclusions Therefore , TGD treatment decreased blood glucose levels and prevented body weight gain in the T2DM patients by inducing the production of oligosaccharides in the alimentary tract and modulating gut microbiota composition . Trial registration UMIN-CTR
Conclusion Probiotic supplementation seemed to be able to reduce the risk of a newborn 's hyperbilirubinemia and improve glycemic control , blood lipid profiles and inflammation and oxidative stress in pregnant women with GDM .
Background Previous studies showed that probiotics could improve glycemic control and attenuate some of the adverse effects of type 2 diabetes .
However , whether the effects are generalizable to gestational diabetes mellitus ( GDM ) remains uncertain .
Objective We conducted a systematic review and meta- analysis to evaluate the effects of probiotic supplement in GDM .