title: A prospective randomised study of the probiotic Lactobacillus plantarum 299V on indices of gut barrier function in elective surgical patients Enhancement of immunity in the elderly by dietary supplementation with the probiotic Bifidobacterium lactis HN019. The Canadian Trial of Carbohydrates in Diabetes (CCD), a 1-y controlled trial of low-glycemic-index dietary carbohydrate in type 2 diabetes: no effect on glycated hemoglobin but reduction in C-reactive protein. Effect of Probiotics on Lipid Profile, Glycemic Control, Insulin Action, Oxidative Stress, and Inflammatory Markers in Patients with Type 2 Diabetes: A Clinical Trial Effects of synbiotic food consumption on glycemic status and serum hs-CRP in pregnant women: a randomized controlled clinical trial Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada Inflammation Modifies the Effects of a Reduced-Fat Low-Cholesterol Diet on Lipids: Results From the DASH-Sodium Trial Synbiotic therapy (Bifidobacterium longum/Synergy 1) initiates resolution of inflammation in patients with active ulcerative colitis: a randomised controlled pilot trial Randomised clinical trial of synbiotic therapy in elective surgical patients Effects of Probiotic Yogurt on Fat Distribution and Gene Expression of Proinflammatory Factors in Peripheral Blood Mononuclear Cells in Overweight and Obese People with or without Weight-Loss Diet Effect of Probiotic (VSL#3) and Omega-3 on Lipid Profile, Insulin Sensitivity, Inflammatory Markers, and Gut Colonization in Overweight Adults: A Randomized, Controlled Trial Randomized Controlled Trial of Strain-Specific Probiotic Formulation (Renadyl) in Dialysis Patients Effects of probiotics on serum levels of Th1/Th2 cytokine and clinical outcomes in severe traumatic brain-injured patients: a prospective randomized pilot study Impact of personalized diet and probiotic supplementation on inflammation, nutritional parameters and intestinal microbiota - The "RISTOMED project": Randomized controlled trial in healthy older people. Probiotic Therapy for the Treatment of Spondyloarthritis: A Randomized Controlled Trial Effects of probiotic therapy on the activity and activation of mild rheumatoid arthritis – a pilot study Effects of Probiotic Supplementation on Pancreatic β-cell Function and C-reactive Protein in Women with Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Clinical Trial Effect of Probiotics (Saccharomyces boulardii) on Microbial Translocation and Inflammation in HIV-Treated Patients: A Double-Blind, Randomized, Placebo-Controlled Trial Effect of Saccharomyces boulardii in Children with Acute Gastroenteritis and Its Relationship to the Immune Response Role of Probiotics on Gut Permeability and Endotoxemia in Patients With Acute Pancreatitis: A Double-Blind Randomized Controlled Trial Effect of probiotics on clinical and immune parameters in enthesitis‐related arthritis category of juvenile idiopathic arthritis Effects of daily consumption of probiotic yoghurt on inflammatory factors in pregnant women: a randomized controlled trial. Perioperative Synbiotic Treatment to Prevent Postoperative Infectious Complications in Biliary Cancer Surgery: A Randomized Controlled Trial Effect of probiotics on pro-inflammatory cytokines and NF-kappaB activation in ulcerative colitis. Reduced Levels of D-dimer and Changes in Gut Microbiota Composition After Probiotic Intervention in HIV-Infected Individuals on Stable ART
abstract: Background : Bacterial translocation occurs in surgical patients and may predispose to postoperative septic morbidity . Many factors are thought to influence the prevalence of bacterial translocation , one of which is the composition of the gut microflora . The aim of this prospect i ve and r and omised study was to assess the effect of the probiotic Lactobacillus plantarum 299v on the incidence of bacterial translocation , gastric colonisation , and septic complications in elective surgical patients . Methods : Patients undergoing elective major abdominal surgery were r and omised to either a treatment or control group . The treatment group received an oral preparation containing Lactobacillus plantarum 299v ( Proviva ) for at least one week preoperatively and also in the postoperative period . Bacterial translocation was determined by culture of a mesenteric lymph node and serosal scraping obtained at laparotomy . Gastric colonisation was assessed by microbiological culture of nasogastric aspirates . All postoperative septic complications were recorded . Results : A total of 129 patients completed the study ( probiotic group n=64 ) . There was no significant difference between the two groups in terms of bacterial translocation ( 12 % v 12 % ; p=0.82 ) , gastric colonisation with enteric organisms ( 11 % v 17 % ; p=0.42 ) , or septic morbidity ( 13 % v 15 % ; p=0.74 ) . Conclusions : Administration of Lactobacillus plantarum 299v  in elective surgical patients does not influence the rate of bacterial translocation , gastric colonisation , or incidence of postoperative septic morbidity BACKGROUND The aging process can lead to a decline in cellular immunity . Therefore , the elderly could benefit from safe and effective interventions that restore cellular immune functions . OBJECTIVE We determined whether dietary supplementation with the known immunostimulating probiotic Bifidobacterium lactis HN019 could enhance aspects of cellular immunity in elderly subjects . DESIGN Thirty healthy elderly volunteers ( age range : 63 - 84 y ; median : 69 y ) participated in a 3-stage dietary supplementation trial lasting 9 wk . During stage 1 ( run-in ) , subjects consumed low-fat milk ( 200 mL twice daily for 3 wk ) as a base-diet control . During stage 2 ( intervention ) , they consumed milk supplemented with B. lactis HN019 in a typical dose ( 5 x 10(10 ) organisms/d ) or a low dose ( 5 x 10(9 ) organisms/d ) for 3 wk . During stage 3 ( washout ) , they consumed low-fat milk for 3 wk . Changes in the relative proportions of leukocyte subsets and ex vivo leukocyte phagocytic and tumor-cell-killing activity were determined longitudinally by assaying peripheral blood sample s. RESULTS Increases in the proportions of total , helper ( CD4(+ ) ) , and activated ( CD25(+ ) ) T lymphocytes and natural killer cells were measured in the subjects ' blood after consumption of B. lactis HN019 . The ex vivo phagocytic capacity of mononuclear and polymorphonuclear phagocytes and the tumoricidal activity of natural killer cells were also elevated after B. lactis HN019 consumption . The greatest changes in immunity were found in subjects who had poor pretreatment immune responses . In general , the 2 doses of B. lactis HN019 had similar effectiveness . CONCLUSION B. lactis HN019 could be an effective probiotic dietary supplement for enhancing some aspects of cellular immunity in the elderly BACKGROUND The optimal source and amount of dietary carbohydrate for managing type 2 diabetes ( T2DM ) are unknown . OBJECTIVE We aim ed to compare the effects of altering the glycemic index or the amount of carbohydrate on glycated hemoglobin ( HbA1c ) , plasma glucose , lipids , and C-reactive protein ( CRP ) in T2DM patients . DESIGN Subjects with T2DM managed by diet alone ( n=162 ) were r and omly assigned to receive high-carbohydrate , high-glycemic-index ( high-GI ) , high-carbohydrate , low-glycemic-index ( low-GI ) , or low-carbohydrate , high-monounsaturated-fat ( low-CHO ) diets for 1 y. RESULTS The high-GI , low-GI , and low-CHO diets contained , respectively , 47 % , 52 % , and 39 % of energy as carbohydrate and 31 % , 27 % , and 40 % of energy as fat ; they had GIs of 63 , 55 , and 59 , respectively . Body weight and HbA1c did not differ significantly between diets . Fasting glucose was higher ( P=0.041 ) , but 2-h postload glucose was lower ( P=0.010 ) after 12 mo of the low-GI diet . With the low-GI diet , overall mean triacylglycerol was 12 % higher and HDL cholesterol 4 % lower than with the low-CHO diet ( P<0.05 ) , but the difference in the ratio of total to HDL cholesterol disappeared by 6 mo ( time x diet interaction , P=0.044 ) . Overall mean CRP with the low-GI diet , 1.95 mg/L , was 30 % less than that with the high-GI diet , 2.75 mg/L ( P=0.0078 ) ; the concentration with the low-CHO diet , 2.35 mg/L , was intermediate . CONCLUSIONS In subjects with T2DM managed by diet alone with optimal glycemic control , long-term HbA1c was not affected by altering the GI or the amount of dietary carbohydrate . Differences in total : HDL cholesterol among diets had disappeared by 6 mo . However , because of sustained reductions in postpr and ial glucose and CRP , a low-GI diet may be preferred for the dietary management of T2DM 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 OBJECTIVE : The aim of this study was to determine the effects of synbiotic food consumption on glycemic status and serum high sensitivity C-reactive protein ( hs-CRP ) levels of Iranian pregnant women . DESIGN : This r and omized placebo-controlled clinical trial was performed among 52 pregnant women , primigravida , aged 18–35 year old , in their third trimester . After a 2-wk run-in period , subjects were r and omly assigned to consume either a synbiotic ( n=26 ) or control food ( n=26 ) for 9 weeks . The synbiotic food consisted of a probiotic Lactobacillus sporogenes ( 1 × 107 CFU ) , 0.04 g inulin as prebiotic with 0.38 g isomalt , 0.36 g sorbitol and 0.05 g stevia as sweetener per 1 g. Control food ( the same substance without probiotic bacteria and inulin ) was packed in identical 9-gram packages . Patients were asked to consume the synbiotic and control foods two times a day . Fasting blood sample s were taken at baseline and after a 9-wk intervention for quantification of related factors . RESULTS : Consumption of a synbiotic food did not show any significant change regarding the impact of insulin actions in the synbiotic group ; nonetheless , compared to the control food , it result ed in a significant decrease in serum insulin levels ( −0.26 vs. 6.34 µIU/mL , P=0.014 ) and HOMA-IR ( −0.13 vs. 1.13 , P=0.033 ) , a significant difference in HOMA-B ( 5.30 vs. 34.22 , P=0.040 ) and a significant rise in QUICKI score ( 0.002 vs. −0.02 , P=0.022 ) . CONCLUSIONS : Consumption of a synbiotic food for 9 weeks by pregnant women had beneficial effects on insulin actions compared to the control food , but did not affect FPG and serum hs-CRP concentrations ABSTRACT Aim : This was a pilot clinical trial to assess biochemical and clinical effects of an oral probiotic dietary supplement in chronic kidney disease ( CKD ) patients ( stages 3 and 4 ) . Methods : A prospect i ve , r and omized , double-blind , crossover , placebo-controlled , 6-month trial of probiotic bacteria was conducted in 16 out patients in Ontario , Canada . Primary endpoints included effect on hematologic , biochemical , and fecal variables , and on general well-being as assessed by quality of life ( QOL ) . These outcomes were evaluated from biochemical parameters , mainly blood urea nitrogen ( BUN ) , creatinine , uric acid , and C-reactive protein ( CRP ) as a general inflammatory marker . QOL was assessed on a subjective scale of 1 to 10 as the secondary parameter . Trial registration : This pilot study forms part of registered trial NCT00760162 . Results : A total of 13 patients completed the study . Three patients dropped out : one was the receiver of a transplant . The second dropped out for unknown reasons and the third died of myocardial infa rct ion ( unrelated to probiotic bacteria or the protocol ) . Among the 13 patients who completed the trial , the mean change in BUN concentration during the probiotic treatment period ( −2.93 mmol/L ) differed significantly ( p = 0.002 ) from the mean change in BUN concentration during the placebo period ( 4.52 mmol/L ) . In addition , the mean changes in uric acid concentration were moderate during the KB period ( 24.70 μmol/L ) versus during the placebo period ( 50.62 μmol/L , p = 0.050 ) , and the changes in serum creatinine concentration were insignificant . Neither gastrointestinal nor infectious complications were noted in any subject with improved QOL . Conclusion : Orally administered probiotic bacteria selected to metabolize nitrogenous wastes may be tolerated for as long as 6 months . A major limitation of this trial is its small size that may have precluded detection of changes in other biochemical or hematologic parameters that would be evident in larger cohorts . Extension of the evaluation of this probiotic bacterial mixture will include a dose escalation trial in a similar prospect i ve , placebo-controlled , and double-blind study site Background —Inflammatory mediators regulate key aspects of lipid metabolism . We hypothesized that inflammation could diminish the cholesterol-lowering effect of a reduced-fat/low-cholesterol diet . Methods and Results —After a 2-week run-in period on a control diet ( 37 % total fat , 16 % saturated fat ) , 100 participants were r and omized to the control or DASH diet ( 27 % total fat , 6 % saturated fat ) for 12 weeks . Median C-reactive protein ( CRP ) at baseline was 2.37 mg/L ( interquartile range , 1.20 , 3.79 ) . The DASH diet , net of control , had no effect on CRP . Overall , there were significant net reductions in total ( −0.34 mmol/L ) , LDL ( −0.29 mmol/L ) , and HDL ( −0.12 mmol/L ) cholesterol from the DASH diet ( each , P < 0.001 ) and little change in triglycerides ( + 0.05 mmol/L , P = 0.21 ) . Baseline CRP was strongly associated with lipid responsiveness to the DASH diet . Total and LDL cholesterol were reduced to a greater degree in those with a “ low ” ( below median ) compared with a “ high ” ( above median ) baseline CRP ( total , −9.8 % versus −3 % ; P for interaction=0.006 ; LDL cholesterol , −11.8 % versus −3 % ; P for interaction=0.009 ) . Reductions in HDL cholesterol ( −8.8 % ) were similar in persons with low versus high CRP . Triglycerides were increased in those with a high CRP but not in those with a low CRP ( 19.8 % versus + 0 % ; P for interaction=0.019 ) . Conclusions —In this study , the presence of increased CRP was associated with less total and LDL cholesterol reduction and a greater increase in triglycerides from a reduced-fat/low-cholesterol diet . These findings document an additional mechanism by which inflammation might increase  cardiovascular disease risk Background and aims : Ulcerative colitis ( UC ) is an acute and chronic inflammatory disease of the large bowel with unknown aetiology . The immune response against normal commensal microorganisms is believed to drive inflammatory processes associated with UC . Therefore , modulation of bacterial communities on the gut mucosa , through the use of probiotics and prebiotics , may be used to modify the disease state . Methods : A synbiotic was developed for use in UC patients combining a probiotic , Bifidobacterium longum , isolated from healthy rectal epithelium , and a prebiotic ( Synergy 1 ) , a preferential inulin-oligofructose growth substrate for the probiotic strain . Treatment was employed in a double blinded r and omised controlled trial using 18 patients with active UC for a period of one month . Clinical status was scored and rectal biopsies were collected before and after treatment , and transcription levels of epithelium related immune markers were measured . Results : Sigmoidoscopy scores ( scale 0–6 ) were reduced in the test group ( start 4.5 ( 1.4 ) , end 3.1 ( 2.5 ) ) compared with placebo ( start 2.6 ( 2.1 ) , end 3.2 ( 2.2 ) ) ( p = 0.06 ) . mRNA levels for human beta defensins 2 , 3 , and 4 , which are strongly upregulated in active UC , were significantly reduced in the test group after treatment ( p = 0.016 , 0.038 , and 0.008 , respectively ) . Tumour necrosis factor α and interleukin 1α , which are inflammatory cytokines that drive inflammation and induce defensin expression , were also significantly reduced after treatment ( p = 0.018 and 0.023 , respectively ) . Biopsies in the test group had reduced inflammation and regeneration of epithelial tissue . Conclusions : Short term synbiotic treatment of active UC result ed in improvement of the full clinical appearance of chronic inflammation in patients receiving this therapy Background : It is possible to manipulate the composition of the gastrointestinal microflora by administration of pre- and probiotics . This may help to preserve gut barrier function and reduce the incidence of septic morbidity . Aims : To assess the effects of a combination of pre- and probiotics ( synbiotic ) on bacterial translocation , gastric colonisation , systemic inflammation , and septic morbidity in elective surgical patients . Patients : Patients were enrolled two weeks prior to elective abdominal surgery . Seventy two patients were r and omised to the synbiotic group and 65 to the placebo group . Patients were well matched regarding age and sex distribution , diagnoses , and POSSUM scores . Methods : Patients in the synbiotic group received a two week preoperative course of Lactobacillus acidophilus La5 , Bifidobacterium lactis Bb-12 , Streptococcus thermophilus , and Lactobacillus bulgaricus , together with the prebiotic oligofructose . Patients in the placebo group received placebo capsules and sucrose powder . At surgery , a nasogastric aspirate , mesenteric lymph node , and scrapings of the terminal ileum were harvested for microbiological analysis . Serum was collected preoperatively and on postoperative days 1 and 7 for measurement of C reactive protein , interleukin 6 , and antiendotoxin antibodies . Septic morbidity and mortality were recorded . Results : There were no significant differences between the synbiotic and control groups in bacterial translocation ( 12.1 % v 10.7 % ; p = 0.808 , χ2 ) , gastric colonisation ( 41 % v 44 % ; p = 0.719 ) , systemic inflammation , or septic complications ( 32 % v 31 % ; p = 0.882 ) . Conclusions : In this study , synbiotics had no measurable effect on gut barrier function in elective surgical patients . Further studies investigating the place of pre- and probiotics in clinical practice are required Objectives : The purpose of this study was to investigate whether probiotics had an effect on proinflammatory markers and cytokines in overweight and obese individuals and whether they could have synergistic effects with weight-loss diets . Methods : A total of 75 healthy overweight and obese individuals completed this r and omized doubled-blind controlled clinical trial . Participants were r and omly assigned to groups consuming regular yogurt with a low-calorie diet ( LCD , RLCD ; n = 25 ) or receiving probiotic yogurt with LCD ( PLCD ; n = 25 ) or consuming probiotic yogurt without LCD ( PWLCD ; n = 25 ) for 8 weeks . The pribiotic regimen contained 200 g/day yogurt , enriched by Lactobacillus acidophilus La5 , Bifidobacterium BB12 , and Lactobacillus casei DN001 108 colony-forming units/g . Body fat percentage , high-sensitive C-reactive protein ( hs-CRP ) , tumor necrosis factor-alpha ( TNF-α ) , leptin , and mRNA levels of inflammation-related genes ( TNF-α and RAR-related orphan receptor gamma [ ROR-γt ] ) in peripheral blood mononuclear cells ( P BMC s ) were measured . Results : A reduction in body mass index ( BMI ) , fat percentage , and leptin level was observed that was more obvious in groups who received the weight-loss diet with probiotic yogurt . Reduction in the gene expression of ROR-γt was significant in the PLCD group ( p < 0.001 ) . The expression of TNF-α did not change among all groups after intervention . The mean concentration of leptin was significantly decreased in all groups after the dietary intervention , but the mean changes in leptin level in the PLCD group was more prominent compared to the other two groups ( −2.38 , p < 0.001 [ PLCD ] vs −1.75 , p = 0.002 [ RLCD ] and −0.55 ng/mL , p = 0.12 [ PWLCD ] ) . The reduction in serum levels of hs-CRP was more evident in the PWLCD group compared to the PLCD and RLCD groups after the 8-week intervention ( −3.4 , p = 0.03 vs −1.76 , p < 0.001 and −2.98 pg/mL , p < 0.001 , respectively ) . Conclusion : Our results suggested that the weight-loss diet and probiotic yogurt had synergistic effects on T-cells subset specific gene expression in P BMC s , fat percentage , and body weight among overweight and obese individuals To evaluate the effects of probiotic ( VSL#3 ) and omega-3 fatty acid on insulin sensitivity , blood lipids , and inflammation , we conducted a clinical trial in 60 overweight ( BMI > 25 ) , healthy adults , aged 40–60 years . After initial screening the subjects were r and omized into four groups with 15 per group . The four groups received , respectively , placebo , omega-3 fatty acid , probiotic VSL#3 , or both omega-3 and probiotic , for 6 weeks . Blood and fecal sample s were collected at baseline and after 6 weeks . The probiotic ( VSL#3 ) supplemented group had significant reduction in total cholesterol , triglyceride , LDL , and VLDL and had increased HDL ( P < 0.05 ) value . VSL#3 improved insulin sensitivity ( P < 0.01 ) , decreased hsCRP , and favorably affected the composition of gut microbiota . Omega-3 had significant effect on insulin sensitivity and hsCRP but had no effect on gut microbiota . Addition of omega-3 fatty acid with VSL#3 had more pronounced effect on HDL , insulin sensitivity and hsCRP .  Subjects with low HDL , insulin resistance , and high hsCRP had significantly lower total lactobacilli and bifidobacteria count and higher E. coli and bacteroides count Background . Primary goal of this r and omized , double-blind , placebo-controlled crossover study of Renadyl in end-stage renal disease patients was to assess the safety and efficacy of Renadyl measured through improvement in quality of life or reduction in levels of known uremic toxins . Secondary goal was to investigate the effects on several biomarkers of inflammation and oxidative stress . Methods . Two 2-month treatment periods separated by 2-month washout and crossover , with physical examinations , venous blood testing , and quality of life question naires completed at each visit . Data were analyzed with SAS V9.2 . Results . 22 subjects ( 79 % ) completed the study . Observed trends were as follows ( none reaching statistical significance ): decline in WBC count ( −0.51 × 109/L , P = 0.057 ) and reductions in levels of C-reactive protein ( −8.61 mg/L , P = 0.071 ) and total indoxyl glucuronide ( −0.11 mg% , P = 0.058 ) . No statistically significant changes were observed in other uremic toxin levels or measures of QOL . Conclusions . Renadyl appeared to be safe to administer to ESRD patients on hemodialysis . Stability in QOL assessment is an encouraging result for a patient cohort in such advanced stage of kidney disease . Efficacy could not be confirmed definitively , primarily due to small sample size and low statistical power — further studies are warranted Introduction Traumatic brain injury ( TBI ) is associated with a profound immunological dysfunction manifested by a severe shift from T-helper type 1 ( Th1 ) to T-helper type 2 ( Th2 ) response . This predisposes patients to infections , sepsis , and adverse outcomes . Probiotic bacteria have been shown to balance the Th1/Th2 cytokines in allergic murine models and patients . For the present study , we hypothesized that the enteral administration of probiotics would adjust the Th1/Th2 imbalance and improve clinical outcomes in TBI patients . Methods We design ed a prospect i ve , r and omized , single-blind study . Patients with severe TBI and Glasgow Coma Scale scores between 5 and 8 were included , result ing in 26 patients in the control group and 26 patients in the probiotic group .  All patients received enteral nutrition via a nasogastric tube within 24 to 48 hours following admission . In addition , the probiotic group received 109 bacteria of viable probiotics per day for 21 days . The associated serum levels of Th1/Th2 cytokines , Acute Physiology and Chronic Health Evaluation ( APACHE ) II and Sequential Organ Failure Assessment ( SOFA ) scores , nosocomial infections , length of ICU stay , and 28-day mortality rate were studied . Results The patients responded to viable probiotics , and showed a significantly higher increase in serum IL-12p70 and IFNγ levels while also experiencing a dramatic decrease in IL-4 and IL-10 concentrations . APACHE II and SOFA scores were not significantly affected by probiotic treatment . Patients in the probiotic group experienced a decreased incidence of nosocomial infections towards the end of the study . Shorter ICU stays were also observed among patients treated with probiotic therapy . However , the 28-day mortality rate was unaffected . Conclusions The present study showed that daily prophylactic administration of probiotics could attenuate the deviated Th1/Th2 response induced by severe TBI , and could result in a decreased nosocomial infection rate , especially in the late period . Trial registration ChiCTR-TRC-10000835 OBJECTIVES To assess the impact of a personalized diet , with or without addition of VSL#3 preparation , on biomarkers of inflammation , nutrition , oxidative stress and intestinal microbiota in 62 healthy persons aged 65 - 85 years . DESIGN Open label , r and omized , multicenter study . PRIMARY ENDPOINT High-sensitivity C-reactive protein . SETTING Community . INTERVENTIONS Eight week web-based dietary advice ( RISTOMED platform ) alone or with supplementation of VSL#3 ( 2 capsules per day ) . The RISTOMED diet was optimized to reduce inflammation and oxidative stress . MEASUREMENTS Blood and stool sample s were collected on days 1 and 56 . RESULTS Diet alone reduced ESR ( p = 0.02 ) , plasma levels of cholesterol ( p < 0.01 ) and glucose ( p = 0.03 ) . Addition of VSL#3  reduced ESR ( p = 0.05 ) and improved folate ( p = 0.007 ) , vitamin B12 ( p = 0.001 ) and homocysteine ( p < 0.001 ) plasma levels . Neither intervention demonstrated any further effects on inflammation . Subgroup analysis showed 40 participants without signs of low- grade inflammation ( hsCRP<3 mg/l , subgroup 1 ) and 21 participants with low- grade inflammation at baseline ( hsCRP≥3 mg/l , subgroup 2 ) . In subgroup 2 addition of VSL#3  increased bifidobacteria ( p = 0.005 ) in more participants and improved both folate ( p = 0.015 ) and vitamin B12 ( p = 0.035 ) levels compared with subgroup 1 . The increases were positively correlated to the change in the bifidobacteria concentration for folate ( p = 0.023 ) and vitamin B12 ( p = 0.001 ) . As expected change in homocysteine correlated negatively to change in folate ( r = -0.629 , p = 0.002 ) and vitamin B12 ( r = -0.482 , p = 0.026 ) . CONCLUSIONS Addition of VSL#3  increased bifidobacteria and supported adequate folate and vitamin B12 concentrations in subjects with low- grade inflammation . Decrease in homocysteine with VSL#3 was clinical ly relevant . suggesting protective potentials for aging-associated conditions , e.g. cardiovascular or neurological diseases . Clinical Trials.gov : NCT01069445-NCT01179789 Objective . To investigate the effect of an orally administered probiotic on disease activity , fatigue , quality of life , and intestinal symptoms in patients with active spondyloarthritis . Methods . Patients with active spondyloarthritis [ defined as Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) ≥ 3 , Bath Ankylosing Spondylitis Functional Index ( BASFI ) ≥ 3 , Maastricht Ankylosing Spondylitis Enthesitis Score ( MASES ) ≥ 2 , or peripheral joint count ≥ 2 ] were r and omized to oral probiotic or placebo for 12 weeks . Patients and assessors were blinded to treatment allocation . The primary outcome measure was 10 % improvement in the BASFI . Additional outcome measures were improvements in the ASsessment s in Ankylosing Spondylitis (ASAS)-endorsed core domains : pain , spinal mobility , patient global , peripheral joint and entheseal scores , stiffness , C-reactive protein , and fatigue . The ASAS20 criteria , a composite measure of response , were also applied . Quality of life and bowel symptoms were quantified using the Ankylosing Spondylitis Quality of Life Question naire ( ASQoL ) and Dudley Inflammatory Bowel Symptom Question naire ( DISQ ) . Results . Sixty-three patients were r and omized to oral probiotic ( n = 32 ) or placebo ( n = 31 ) . All patients completed the trial . No significant difference was noted between groups in any of the core domains . The mean BASFI fell from 3.5 ± 2.0 to 2.9 ± 1.9 in the probiotic group and from 3.6 ± 1.9 to 3.1 ± 2.2 in the placebo group ( p = 0.839 ) . The mean BASDAI fell from 4.2 ± 2.2 to 3.2 ± 2.1 in the probiotic group and 4.5 ± 2.0 to 3.9 ± 2.2 in the placebo group ( p = 0.182 ) . No significant adverse events were recorded in the probiotic-treated group . Conclusion . In this r and omized controlled trial , the probiotic combination administered did not demonstrate significant benefit over placebo , despite a theoretical rationale for this therapy Objective : To study the effects of Lactobacillus rhamnosus GG ( LGG ) on rheumatoid arthritis ( RA ) . Methods : Twenty‐one RA patients were r and omised to receive 2 capsules of LGG or a placebo twice daily in double‐blind fashion for 12 months . Arthritis activity was evaluated by clinical examination , HAQ index , and laboratory tests ( e.g. ESR , CRP , pro‐ and anti‐inflammatory cytokines ) . Results : There were no statistical differences in the clinical parameters , biochemical variables and HAQ index between the study groups over the intervention period . The mean number of tender and swollen joints decreased from 8.3 to 4.6 in the Lactobacillus group and from 5.5 to 4.8 in the placebo group ( p=0.41 ) . According to the global assessment the RA activity was reduced in 71 % ( LGG group ) vs. 30 % ( controls ) ( p=0.15 ) . Serum IL‐1β increased slightly in the LGG group ( p=0.07 ) , but no differences were seen in IL‐6 , TNF‐α , MPO , IL‐10 or 1L‐12 . Conclusions : Although there were no statistical significant differences in the activity of RA , more subjects in the LGG group reported subjective well being . More studies on the effects of probiotic bacteria in RA are needed Background : Polycystic ovary syndrome ( PCOS ) is a polygenic endocrine disorder in women of reproductive age that lead to infertility . The aim of this study was to investigate the effects of probiotic on pancreatic β-cell function and C-reactive protein ( CRP ) in PCOS patients . Methods : This r and omized double-blind placebo-controlled clinical trial was conducted among 72 women aged 15–40 years old diagnosed with PCOS . Participants were r and omly assigned to two groups receiving : ( 1 ) Probiotic supplements ( n = 36 ) , ( 2 ) placebo ( n = 36 ) for 8-week . Fasting blood sample s were taken at baseline and after 8-week of intervention . Results : Probiotic supplementation , compare with placebo , reduced fasting blood sugar ( −4.15 ± 2.87 vs. 2.57 ± 5.66 mg/dL , respectively P = 0.7 ) , serum insulin levels in crude model ( −0.49 ± 0.67 vs. 0.34 ± 0.82 μIU/mL , respectively , P = 0.09 ) , homeostasis model of assessment -insulin resistance score ( −0.25 ± 0.18 vs. −0.05 ± 0.18 , respectively , P = 0.14 ) nonsignificantly . Serum insulin levels after adjustment with covariates reduced significantly in probiotic group ( P = 0.02 ) . We did not found any significant differences in mean changes of CRP between groups ( −0.25 ± 0.18 vs. −0.05 ± 0.18 , respectively , P = 0.14 ) . Conclusions : A 8-week multispecies probiotics supplementation had nonsignificantly beneficial effect on pancreatic β-cell function and CRP in PCOS patients . After adjustment for some covariates , serum insulin changes were significantly different between groups Background : Microbial translocation has been associated with an increase in immune activation and inflammation in HIV infection despite effective highly active antiretroviral therapy . It has been shown that some probiotics have a beneficial effect by reducing intestinal permeability and , consequently , microbial translocation . Objectives : To assess changes in microbial translocation and inflammation after treatment with probiotics ( Saccharomyces boulardii ) in HIV-1–infected patients with virologic suppression . Methods : A double-blind , r and omized , placebo-controlled trial was conducted in 44 nonconsecutive HIV-1–infected patients with viral load of < 20 copies per milliliter for at least 2 years . Patients were r and omized to oral supplementation with probiotics or placebo during 12 weeks . Markers of microbial translocation ( lipopolysaccharide-binding protein [ LBP ] and soluble CD14 ) , inflammation ( interleukin 6 [ IL-6 ] , tumor necrosis factor alpha , interferon gamma , high-sensitivity C-reactive protein ) , and immunological and clinical data were determined before and after the intervention and 3 months after treatment discontinuation . Quantitative variables were compared using the Mann – Whitney U test , and categorical variables were compared using the Fisher exact test . Results : After 12 weeks of treatment , differences between the probiotic arm and the placebo arm were observed in LBP values ( −0.30 vs + 0.70 pg/mL ) and IL-6 ( −0.60 vs + 0.78 pg/mL ) . These differences were also noted at 3 months after treatment withdrawal . Qualitative analysis was performed , defining a variable as “ decreased ” or “ increased ” from baseline LBP . A significant decrease of LBP at 12 weeks of treatment was observed ( 57.9 % patients in the probiotic group vs 6.2 % in the placebo group , P = 0.002 ) . Conclusions : Treatment with S. boulardii decreases microbial translocation ( LBP ) and inflammation parameters ( IL-6 ) in HIV-1–infected patients with long-term virologic suppression We evaluated the effect of Saccharomyces boulardii administration in otherwise healthy children aged between 6 months and 10 years who were admitted for acute diarrhoea ( 15 males , 12 females ) . The patients were r and omized into two groups : group 1 ( n = 16 ) received 250 mg S. boulardii dissolved in 5 ml of water orally twice daily for 7 days and group 2 ( n = 11 ) received placebo . Clinical and laboratory assessment s were performed on admission and on day 7 of follow-up . Both groups experienced reduced daily stool frequency , the decrease being significantly greater in group 1 on days 3 and 4 compared with group 2 . Group 1 demonstrated significant increases in serum immunoglobulin A and decreases in C-reactive protein levels on day 7 . The percentage of CD8 lymphocytes on day 7 was significantly higher in group 1 than group 2 . This study confirmed the efficacy of S. boulardii in paediatric acute gastroenteritis and the findings suggest that S. boulardii treatment enhances the immune response Goals To study the role of probiotics on gut permeability and endotoxemia in patients with acute pancreatitis ( AP ) . Background Bacterial translocation has been implicated in infective complications in AP , which has been shown to be prevented by probiotics . Study A double-blind , r and omized placebo-controlled trial was conducted . Consecutive patients with AP presenting within 72 hours after the onset of abdominal pain or who had been nil orally at the time of presentation for up to 5 days were included in the study . The probiotic group received 4 sachets of Probiotics ( 2.5 billion bacteria per sachet ) whereas the placebo group received 4 sachets of placebo for 7 days . Primary outcome measures were effect on gut permeability [ assessed by lactulose/mannitol ( L/M ) excretion in urine ] and endotoxemia assessed by endotoxin-core antibody types IgG and IgM ( EndoCab IgG and IgM ) . Secondary outcome measures were mortality , total hospital/intensive care unit stay , abdominal discomfort , organ failure , C-reactive protein , and prealbumin levels . The study was prematurely stopped after the publication of probiotic prophylaxis in patients with predicted severe acute pancreatitis trial . Results From March 2007 to May 2008 , 50 patients with AP were included in the study ( 26 in placebo group and 24 in probiotic group ) . There was no difference after intervention in gut permeability , whereas values of C-reactive protein and immunoglobulins decreased significantly [ IgG : 140 ( 20–920 ) to 90 ( 20–600 ) GGU/mL and IgM : 65 ( 13–230 ) to 51 ( 9–240 ) GMU/mL ] in the probiotic group . No difference was observed in prealbumin values , duration of hospital/intensive care unit stay , and mortality in both the groups . Conclusions No significant trend was identified for an effect of probiotics on gut permeability or endotoxemia in AP . However , the study was underpowered owing to premature study termination Gut microflora and dysbiosis as an environmental factor has been linked to the pathogenesis of enthesitis‐related arthritis ( JIA‐ERA ) ; thus , we performed a proof‐of‐concept study of probiotics to modulate the gut‐flora and study the effects on immune and clinical parameters of children having JIA‐ERA . Forty‐six children with active JIA‐ERA were r and omized to placebo or probiotic therapy along with non‐steroidal anti‐inflammatory drugs ( NSAIDs ) for 12 weeks . Patients were assessed using a six‐point composite disease activity index ( mJSpADA ) based on morning stiffness , joint count , enthesitis count , sacroiliitis/inflammatory back pain , uveitis and erythrocyte sedimentation rate/C‐reactive protein ( ESR/CRP ) . Frequencies of T helper type 1 ( Th1 ) , Th2 , Th17 and regulatory T cells in blood were measured using flow cytometry . Serum cytokines interferon (IFN)‐γ , interleukin (IL)−4 , IL‐17 , IL‐10 , tumour necrosis factor (TNF)‐α and IL‐6 were measured by cytokine bead array using flow cytometer . The average age of 46 children ( 44 boys ) was 15 ± 2.5 years and duration of disease was 3.5 ± 3 years . There was no significant difference in improvement in mJSpADA between the two groups ( P = 0·16 ) . Serum IL‐6 levels showed a decrease ( P < 0·05 ) in the probiotic‐group . Th2 cell frequency ( P < 0·05 ) and serum IL‐10 levels ( P < 0·01 ) showed an increase in the placebo group , but again the probiotic use did not show a significant change in immune parameters when compared to the placebo . Adverse effects among the probiotic and placebo groups were diarrhea ( 36 versus 45 % ) , abdominal pain ( 9 versus 20 % ) , minor infections ( 4·5 versus 20 % ) and flatulence ( 23 versus 15 % ) , respectively . Thus , we can conclude that  probiotic therapy in JIA‐ERA children is well tolerated , but failed to show any significant immune or clinical effects over NSAID therapy Previous studies have shown that inflammatory factors increases in pregnancy and is associated with several complications of pregnancy . The aim of this study was to assess effects of daily consumption of probiotic yoghurt on inflammatory factors in pregnant women . In a r and omized clinical trial , seventy primigravid ( the first pregnancy ) and singleton pregnant women aged 18 - 30 years were assigned to two groups . Subjects consumed daily 200 g probiotic yoghurt containing Lactobacillus acidophilus La5 and Bifidobacterium animalis BB12 ( 10(7 ) CFU g(-1 ) for each ) or 200 g conventional yoghurt for 9 weeks . Fasting blood sample s were collected at baseline ( 28 weeks of gestation ) and after intervention ( 37 weeks of gestation ) . Inflammatory factors , hs-CRP and TNF-alpha , were measured by Enzyme-linked Immunosorbent Assay ( ELISA ) . Independent t-test was used to compare the two groups after intervention and paired- sample t-test compared variables before and after treatment . The results showed that the probiotic yogurt brought about a decrease in the serum hs-CRP level , from 10.44 + /- 1.56 to 7.44 + /- 1.03 microg mL(-1 ) ( p = 0.041 ) . There was no significant change in the conventional yogurt group in the serum hs-CRP level ( 12.55 + /- 1.57 to 14.51 + /- 1.62 microg mL(-1 ) , p = 0.202 ) . The probiotic yogurt had no effect on TNF-alpha ( from 73.75 + /- 6.59 to 77.91 + /- 5.61 pg mL(-1 ) , p = 0.633 ) . Serum TNF-alpha did not change in the conventional yogurt group ( p = 0.134 ) . In conclusion probiotic yogurt significantly decreased hs-CRP in pregnant women but had no effect on TNF-alpha Summary Background Data : Use of synbiotics has been reported to benefit human health , but clinical value in surgical patients remains unclear . Objective : To investigate the effect of perioperative oral administration of synbiotics upon intestinal barrier function , immune responses , systemic inflammatory responses , microflora , and surgical outcome in patients undergoing high-risk hepatobiliary resection . Methods : Patients with biliary cancer involving the hepatic hilus ( n = 101 ) were r and omized before hepatectomy  , into a group receiving postoperative enteral feeding with synbiotics ( group A ) ; or another receiving preoperative plus postoperative synbiotics ( group B ) . Lactulose-mannitol ( L/M ) ratio , serum diamine oxidase ( DAO ) activity , natural killer ( NK ) cell activity , interleukin-6 ( IL-6 ) , fecal microflora , and fecal organic acid concentrations were determined before and after hepatectomy . Postoperative infectious complications were recorded . Results : Of 101 patients , 81 completed the trial . Preoperative and postoperative changes in L/M ratio and DAO activity were similar between groups . Preoperatively in group B , NK activity , and lymphocyte counts increased , while IL-6 decreased significantly ( P < 0.05 ) . Postoperative serum IL-6 , white blood cell counts , and C-reactive protein in group B were significantly lower than in group A ( P < 0.05 ) . During the preoperative period , numbers of Bifidobacterium colonies cultured from and total organic acid concentrations measured in feces increased significantly in group B ( P < 0.05 ) . Postoperative concentrations of total organic acids and acetic acid in feces were significantly higher in group B than in group A ( P < 0.05 ) . Incidence of postoperative infectious complications was 30.0 % ( 12 of 40 ) in group A and 12.1 % ( 5 of 41 ) in group B ( P < 0.05 ) . Conclusions : Preoperative oral administration of synbiotics can enhance immune responses , attenuate systemic postoperative inflammatory responses , and improve intestinal microbial environment . These beneficial effects likely reduce postoperative infectious complications after hepatobiliary resection for biliary tract cancer AIM To demonstrate the therapeutic effect of probiotics in patients with ulcerative colitis ( UC ) , and their effect on inflammatory mediators and nuclear factor (NF)-kappaB activation in these patients . METHODS Thirty patients with mild to moderate UC were r and omly classified into two groups : sulfasalazine group , who received sulfasalazine 2400 mg/d ; and probiotic group , who received sulfasalazine 2400 mg/d with probiotic . The patients were investigated before and after 8 wk of treatment with probiotic ( Lactobacillus delbruekii and Lactobacillus fermentum ) .  Colonic activity of myeloperoxidase ( MPO ) was assayed with UV spectrophotometry , the colonic content of interleukin (IL)-6 was determined by enzyme-linked immunosorbent assay ( ELISA ) , fecal calprotectin was determined by ELISA , and expression of NF-kappaB p65 and tumor necrosis factor (TNF)-alpha proteins in colonic tissue was identified by immunohistochemistry and reverse transcription polymerase chain reaction , respectively . RESULTS At the start of the study , colonic mucosal injury and inflammation were demonstrated in UC patients by hematoxylin and eosin staining , and an increase in colonic MPO activity , fecal calprotectin , and expression of colonic TNF-alpha and NF-kappaB p65 proteins . The use of probiotic for 8 wk significantly ameliorated the inflammation by decreasing the colonic concentration of IL-6 , expression of TNF-alpha and NF-kappaB p65 , leukocyte recruitment , as demonstrated by a decrease in colonic MPO activity , and the level of fecal calprotectin compared to sulfasalazine group and the control group ( P < 0.05 ) . CONCLUSION Oral supplementation with probiotics could be helpful in maintaining remission and preventing relapse of UC Background : Microbial translocation and chronic inflammation may contribute to non-AIDS morbidity in patients with HIV . This study assessed the impact of probiotic intervention on microbial translocation and inflammation in patients on antiretroviral therapy with viral suppression and subnormal CD4 count . Methods : Thirty-two patients receiving antiretroviral therapy ( CD4 < 500 cells/&mgr;L ) were r and omized in a double-blind fashion to multistrain daily probiotics ( n = 15 ) , placebo ( n = 9 ) , or controls ( n = 8) for 8 weeks . Soluble inflammation markers , D-dimer , lipopolysaccharide ( LPS ) , sCD14 , T-cell activation , tryptophan metabolites , and gut microbiota composition were analyzed at baseline and end of study . Nonparametric statistics were applied . Results : Twenty-four participants completed the study and were included in as-treated analyses . In patients receiving probiotics , there was a significant reduction in D-dimer levels ( median change 33 % , P = 0.03 ) and a tendency to reduced levels of C-reactive protein ( CRP ) ( P = 0.05 ) and interleukin (IL)-6 ( P = 0.06 ) . The changes in CRP and IL-6 were highly correlated ( r = 0.95 , P < 0.01 ) , whereas changes in D-dimer did not correlate with changes in CRP or IL-6 . Increases in Bifidobacteria ( P = 0.04 ) and Lactobacilli ( P = 0.06 ) were observed in the probiotic group , whereas the relative abundance of Bacteroides decreased ( P ⩽ 0.01 ) . No significant changes were seen in markers of microbial translocation or T-cell activation . However , the expansion of Bifidobacteria correlated negatively with differences in LPS ( r = −0.77 , P = 0.01 ) , whereas the reduction in Bacteroides correlated positively with changes in LPS during the study period ( r = 0.72 , P = 0.02 ) . Conclusions : Probiotic intervention seemed to reduce markers of coagulation and inflammation without overt changes in microbial translocation . These findings warrant further studies in larger cohorts with long-term follow-up
target: This meta- analysis suggests that probiotic administration may significantly reduce serum CRP while having no significant effect on serum IL10 and TNF-α
background: We conducted this systematic review and meta- analysis of prospect i ve studies to determine the effect of  probiotic administration on serum C-reactive protein ( CRP ) concentrations .