title: Probiotics and dietary counselling contribute to glucose regulation during and after pregnancy: a randomised controlled trial. Is there a value for probiotic supplements in gestational diabetes mellitus? A randomized clinical trial The Effects of Synbiotic Supplementation on Pregnancy Outcomes in Gestational Diabetes Early pregnancy probiotic supplementation with Lactobacillus rhamnosus HN001 may reduce the prevalence of gestational diabetes mellitus: a randomised controlled trial Effects of a Multispecies Probiotic Mixture on Glycemic Control and Inflammatory Status in Women with Gestational Diabetes: A Randomized Controlled Clinical Trial Impact of maternal probiotic-supplemented dietary counselling on pregnancy outcome and prenatal and postnatal growth: a double-blind, placebo-controlled study. Effect of daily consumption of probiotic yoghurt on insulin resistance in pregnant women: a randomized controlled trial Probiotics in obese pregnancy do not reduce maternal fasting glucose: a double-blind, placebo-controlled, randomized trial (Probiotics in Pregnancy Study). Effects of probiotic supplementation on glycaemic control and lipid profiles in gestational diabetes: A randomized, double-blind, placebo-controlled trial. Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy. Effects of probiotic supplements on insulin resistance in gestational diabetes mellitus: A double‐blind randomized controlled trial The effects of probiotic supplementation on biomarkers of inflammation, oxidative stress and pregnancy outcomes in gestational diabetes Effect of maternal supplement beverage with and without probiotics during pregnancy and lactation on maternal and infant health: a randomized controlled trial in the Philippines Probiotics for the Prevention of Gestational Diabetes Mellitus in Overweight and Obese Women: Findings From the SPRING Double-Blind Randomized Controlled Trial Effect of antenatal dietary interventions in maternal obesity on pregnancy weight-gain and birthweight: Healthy Mums and Babies (HUMBA) randomized trial. Effect of probiotic yoghurt on plasma glucose in overweight and obese pregnant women: a randomized controlled clinical trial
abstract: 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 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 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 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 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 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 Background / objectives : Owing to excess body weight and increased secretion of inflammatory cytokines primarily during the third trimester , pregnancy is associated with elevated insulin resistance . To our knowledge , no report is available indicating the effects of probiotic yoghurt consumption on serum insulin levels in pregnant women . This study was design ed to determine the effects of daily consumption of probiotic yoghurt on insulin resistance and serum insulin levels of Iranian pregnant women . Subjects/ methods : In this r and omized controlled clinical trial , 70 primigravida pregnant women with singleton pregnancy at their third trimester were participated . We r and omly assigned participants to consume 200 g per day of conventional ( n=33 ) or the probiotic group ( n=37 ) for 9 weeks . The probiotic yoghurt was a commercially available product prepared with the starter cultures of Streptococcus thermophilus and Lactobacillus bulgaricus , enriched with probiotic culture of two strains of lactobacilli ( Lactobacillus acidophilus LA5 ) and bifidobacteria ( Bifidobacterium animalis BB12 ) with a total of min 1 × 107 colony-forming units . Fasting blood sample s were taken at baseline and after 9-week intervention to measure fasting plasma glucose and serum insulin levels . Homeostatic model assessment of insulin resistance ( HOMA-IR ) was used to calculate insulin resistance score . Results : Although consumption of probiotic yogurt for 9 weeks did not affect serum insulin levels and HOMA-IR score , significant differences were found comparing changes in these variables between probiotic and conventional yogurts ( changes from baseline in serum insulin levels : + 1.2±1.2 vs + 5.0±1.1 μIU/ml , respectively , P=0.02 ; and in HOMA-IR score : −0.2±0.3 vs 0.7±0.2 , respectively , P=0.01 ) . Conclusions : It is concluded that in contrast to conventional yogurt , daily consumption of probiotic yogurt for 9 weeks maintains serum insulin levels and might help pregnant women prevent developing insulin resistance 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 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 Lactic acid bacteria and bifidobacteria are increasingly being administered to pregnant women and infants with the intention of improving health . Although these organisms have a long record of safe use , it is important to identify any adverse effects in potentially vulnerable population s. In a r and omized , double-blinded , placebo-controlled trial , we evaluated the safety of a bacterial dietary supplement for the prevention of atopy in infants .  Two strains of lactobacilli ( Lactobacillus salivarius CUL61 and Lactobacillus paracasei CUL08 ) and bifidobacteria ( Bifidobacterium animalis subsp . lactis CUL34 and Bifidobacterium bifidum CUL20 ) with a total of 1 x 10(10 ) colony-forming units were administered daily to women during the last month of pregnancy and to infants aged 0 - 6 mo .  Adverse events ( AE ) were classified according to WHO International Statistical Classification of Diseases criteria . Common symptoms were recorded by regular question naires . Baseline characteristics of 220 mother-infant dyads in the treatment and 234 in the placebo group were similar . Compliance with the trial interventions , loss to follow-up , symptoms , drug usage , infant growth , method of feeding , visits to the doctor , and mothers ' assessment of infant health were similar in the 2 groups . Fifteen ( 6.8 % ) mothers and 73 ( 33.2 % ) infants in the treatment group and 21 ( 9.0 % ) mothers and 75 ( 32.1 % ) infants in the placebo group reported AE ( P = 0.49 and P = 0.84 , respectively ) . Severe AE occurred in 18 mothers and 63 infants with a similar frequency in each group . None of the AE were attributed to the intervention . Our findings support the safe use of this consortium of organisms during pregnancy and early infancy 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 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 Background Adequate nutrition is essential during pregnancy and lactation to provide sufficient energy and nutrients to meet the nutritional requirements of the mother , fetus and infant . The primary objective of this study was to assess the effect of a maternal nutritional supplement enriched with probiotics during pregnancy and early lactation on the incidence of  infant diarrhea . Methods Healthy , pregnant ( 24–28 weeks gestation ) women were r and omized 1:1:1 to receive either no supplement or two servings per day of an oral supplement ( 140 kcal/serving ) providing 7.9 g protein , multivitamin/minerals , and enriched or not with the probiotics Lactobacillus rhamnosus and Bifidobacterium lactis , from the third trimester of pregnancy until at least 2 months post-delivery . Incidence of infant diarrhea until 12 months post-delivery was analyzed by Poisson regression . The effect on maternal health , fetal growth , and infant growth and morbidity were also evaluated and analyzed by ANOVA . Results A total of 208 mother/infant pairs were included in the analysis . No significant difference in the incidence of infant diarrhea was observed between the three study groups . The mean maternal weight gains at delivery were similar among groups , despite an increase in caloric intake in the supplemented groups . No statistically significant differences between groups were observed in incidence of pregnancy-related or fetal adverse outcomes . Mean weight- , length- , BMI - and head circumference-for-age z-scores were below the WHO median value for all groups . Post-hoc analysis to compare the effect of the combined supplement groups versus the no supplement group on infant growth parameters showed , at 12 months , that the combined supplemented group had gained statistically significant more weight ( 8.97 vs. 8.61 kg , p = 0.001 ) and height ( 74.2 vs. 73.4 cm , p = 0.031 ) , and had a higher weight-for-age z-score ( − 0.62 vs. -0.88 , p = 0.045 ) than the no supplement group . Conclusions Maternal nutritional supplement with or without probiotics given during late pregnancy and early lactation was well tolerated and safe . Even though no difference in incidence of infant diarrhea was observed between the three groups , the analysis of the combined supplemented groups showed beneficial effects of maternal supplementation on infant weight and length gains at 12 months . Trial registration Clinical Trial.gov : NCT01073033 . Registered 17.02.2010 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 Pregnancy interventions that improve maternal and infant outcomes are urgently needed in population s with high rates of obesity . We undertook the Healthy Mums and Babies ( HUMBA ) r and omized controlled trial to assess the effect of dietary interventions and or probiotics in a multiethnic population of pregnant women with obesity , living in an area of high deprivation . OBJECTIVES To determine whether a culturally tailored dietary intervention and or daily probiotic capsules in pregnant women with obesity reduces the co- primary outcomes of ( 1 ) excessive gestational weight gain ( mean > 0.27 kg/week ) and ( 2 ) birthweight . STUDY DESIGN We conducted a 2 × 2 factorial , r and omized controlled trial in women without diabetes at pregnancy booking , body mass index ≥30 kg/m2 , and a singleton pregnancy . At 12 + 0 to 17 + 6 weeks ' gestation , eligible women were r and omized to a dietary intervention ( 4 tailored educational sessions at ≤28 weeks ' gestation by a community health worker trained in key aspects of pregnancy nutrition plus text messaging until birth ) or to routine dietary advice ; and to daily capsules containing either ( Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 , minimum 6.5 × 109 colony forming units ) , or placebo , until birth . Analysis was by intention to treat with adjustment for maternal baseline body mass index . Infant outcomes were additionally adjusted for ethnicity , sex , and gestational age at birth . RESULTS In total , 230 women were recruited between April 2015 and June 2017 ( dietary intervention N = 116 vs routine dietary advice N = 114 ; probiotics N = 115 vs placebo N = 115 ) . Baseline characteristics and demographic variables were similar across all groups . There was no significant difference between intervention groups , for the co- primary outcomes of ( 1 ) proportion of women with excessive gestational weight gain  ( dietary intervention vs routine advice : 79/107 [ 73.8 % ] vs 90/110 [ 81.8 % ] , adjusted relative risk [ relative risk , 0.92 ; 95 % confidence interval , 0.80 - 1.05 ] ; probiotics versus placebo : 89/108 [ 82.4 % ] and 80/109 [ 73.4 % ] , relative risk , 1.14 , 95 % confidence interval , 0.99 - 1.31 ) or ( 2 ) birthweight ( dietary intervention vs routine advice : 3575 vs 3612 g , adjusted mean difference , -24 g , 95 % confidence interval , -146 to 97 ; probiotics vs placebo : 3685 vs 3504 g , adjusted mean difference , 107 g , 95 % confidence interval , -14 to 228 ) . Total maternal weight gain , a secondary outcome , was lower with dietary intervention compared with routine dietary advice ( 9.7 vs 11.4 kg , adjusted mean difference , -1.76 , 95 % confidence interval , -3.55 to 0.03 ) . There were no significant differences between intervention groups in other secondary maternal or neonatal outcomes . CONCLUSION Although dietary education and or probiotics did not alter rates of excessive gestational weight gain or birthweight in this multiethnic , high-deprivation population of pregnant women with obesity , dietary education was associated with a modest reduction in total weight gain with potential future benefit for the health of mothers and their offspring if sustained Introduction There is only some evidence about effectiveness of probiotics for preventing gestational hyperglycaemia . This trial examined the effects of probiotic yoghurts containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 on maternal plasma glucose ( primary outcome ) and on some maternal and infant complications ( secondary outcomes ) in overweight and obese women with no diabetes in pregnancy . Methods Using stratified block r and omization , women with pre- or early-pregnancy BMI ≥ 25 and fasting plasma glucose < 92 mg/dl at 22 weeks of gestation were assigned into probiotic or conventional yoghurt group , consuming 100 g/day from 24 weeks of gestation until delivery . The women and their infants were followed up until 1 month after birth . Results In each group , one out of 65 women  had intra-uterine foetal death and were not analysed for other outcomes . The mean BMI was 29.2 ( SD 3.3 ) in probiotic and 30.3 ( SD 4.1 ) in conventional yoghurt group . Four weeks after initiation of the treatment , plasma glucose levels were significantly lower in the probiotic than in conventional yoghurt group at fasting ( mean difference adjusted for the BMI category ) and baseline FPG ( − 4.0 mg/dl ; 95 % confidence interval − 6.9 , − 1.1 ) and 2-h OGTT ( − 13.9 ; − 22.8 , − 5.0 ) . At the 1-h OGTT , however , the difference was not statistically significant ( − 9.8 ; − 20.6 , 0.9 ) . Further , there was a significantly lower infant bilirubin level in the probiotic group on days 3–5 after birth ( − 2.2 mg/dl ; − 3.3 , − 1.2 ) . There were not statistically significant differences between the groups regarding the risk of gestational diabetes ( 6 vs 11 ; odds ratio 0.5 ; 0.2 , 1.5 ) , preterm delivery ( 3 vs 8 ; 0.3 ; 0.1 , 1.2 ) , and other maternal and infant outcomes . Conclusion The probiotics supplementation has some beneficial effects on glucose metabolism of overweight and obese pregnant women . Nevertheless , further studies are required to judge the clinical significance of such effects
target: Among secondary endpoints , a significant reduction of maternal insulin ( both in women with or without diabetes ) was observed in the probiotics group .
  INTERPRETATION Probiotics during pregnancy do not reduce the incidence of GDM , with a very little ( statistically but not clinical ly significant ) reduction of fasting plasma glucose
background: AIM To perform a systematic review and meta- analysis of r and omized controlled trials ( RCTs ) to evaluate the effect of  probiotics in pregnancy on the  incidence of gestational diabetes ( GDM ) and fasting plasma glucose ( FPG ) .