Effects of a symbiotic on gut microbiota in Mexican patients with end-stage renal disease. Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada Pilot study of probiotic dietary supplementation for promoting healthy kidney function in patients with chronic kidney disease Effect of probiotics on human blood urea levels in patients with chronic renal failure. SYNbiotics Easing Renal failure by improving Gut microbiologY (SYNERGY): a protocol of placebo-controlled randomised cross-over trial Probiotic Supplementation in Chronic Kidney Disease: A Double-blind, Randomized, Placebo-controlled Trial. The effect of probiotics on serum levels of cytokine and endotoxin in peritoneal dialysis patients: a randomised, double-blind, placebo-controlled trial. Effects of probiotics in patients with diabetes mellitus type 2: study protocol for a randomized, double-blind, placebo-controlled trial Probiotics and prebiotics in gastrointestinal disorders A Systematic Review of Probiotic Interventions for Gastrointestinal Symptoms and Irritable Bowel Syndrome in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) Randomized Controlled Trial of Strain-Specific Probiotic Formulation (Renadyl) in Dialysis Patients Efficacy of Probiotics and Nutrients in Functional Gastrointestinal Disorders: A Preliminary Clinical Trial A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome A double‐blind, placebo‐controlled study to assess the effect of a probiotic mixture on symptoms and inflammatory markers in women with diarrhea‐predominant IBS Effect of administering a multi-species probiotic mixture on the changes in fecal microbiota and symptoms of irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial Effect of Probiotics on Symptoms in Korean Adults with Irritable Bowel Syndrome Effect of microbial cell preparation on renal profile and liver function among type 2 diabetics: a randomized controlled trial
OBJECTIVES Gut microbiota provides beneficial effects under physiological conditions , but is able to contribute to inflammatory diseases in susceptible individuals . Thus , we design ed this study to test whether additional intake of symbiotic gel affects specific modifications of gut microbiota in patients with end-stage renal disease ( ESRD ) . METHODS Eighteen patients with ESRD diagnosis with renal replacement therapy ( hemodialysis ) were included in this study . They were r and omly assigned to 2 treatment groups : ( 1 ) test group ( nutritional counseling + symbiotic ) and ( 2 ) control group ( nutritional counseling + placebo ) . Clinical history and the evaluation of Gastrointestinal Symptom Rating Scale were performed . Gut microbiota composition was analyzed by real-time polymerase chain reaction from fecal sample s. All subjects were followed for 2 months . RESULTS Bifidobacterial counts were higher in the second sample s ( mean : 5.5 ± 1.72 log10 cells/g ) than in first sample s ( 4.2 ± 0.88 log 10 cells/g ) in the patients of the test group ( P = .0344 ) . Also , lactobacilli counts had a little decrease in the test group ( 2.3 ± 0.75 to 2.0 ± 0.88 log 10 cells/g ) and the control group ( 2.2 ± 0.90 to 1.8 ± 1.33 log 10 cells/g ) , between the first and the second sample s. Gastrointestinal symptoms scores ( scale 8 - 40 ) were reduced in the test group ( start 12 [ 10 - 14 ] and end 9 [ 8 - 10 ] ) compared with control group ( start 11 [ 8 - 21 ] and end 11 [ 9 - 15 ] ) . CONCLUSIONS Short-term symbiotic treatment in patients with ESRD can lead to the increase of Bifidobacterium counts , maintaining the intestinal microbial balance 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 Introduction Uremic syndrome consists of nitrogenous waste retention , deficiency in kidney-derived hormones , and reduced acid excretion , and , if untreated , may progress to coma and eventual death . Previous experience suggests that oral administration of a probiotic formulation of selected microbial strains may extend renoprotection via intraintestinal extraction of toxic waste solutes in patients with chronic kidney disease (CKD)stages 3 and 4 . This report presents preliminary data from a pilot study . Methods This was a 6-month prospect i ve , r and omized , double-blind , placebo-controlled crossover trial of a probiotic bacterial formulation conducted in four countries , at five institutions , on 46 out patients with CKD stages 3 an nd 4 : USA ( n=10 ) , Canada ( n=113 ) , Nigeria ( n=115 ) , and Argentina ( n=8 ) . Outcomes were compared using biochemical parameters : blood urea nitrogen ( BUN ) , serum creatinine , and uric acid . General well-being was assessed as a secondary parameter by a quality of life ( QQOL ) question naire on a subjective scale of 1–10 . Results Oral ingestion of probiotics ( 90 billion colony forming units [CFUs]/day ) was well tolerated and safe during the entire trial period at all sites . BUN levels decreased in 29 patients ( 63 % , P<0.05 ) , creatinine levels decreased in 20 patients ( 43 % , no statistical significance ) , and uric acid levels decreased in 15 patients ( 33 % , no statistical significance ) . Almost all subjects expressed a perceived substantial overall improvement in QOL ( 86 % , P<0.05 ) . Conclusion The main outcomes of this preliminary trial include a significant reduction of BUN , enhanced well-being , and absence of serious adverse effects , thus supporting the use of the chosen probiotic formulation for bowel-based toxic solute extraction . QOL and BUN levels showed statistically significant differences in outcome ( P<0.05 ) between placebo and probiotic treatment periods at all four sites ( 46 patients ) . A major limitation of this trial is the small sample size nd elated inconsistencies INTRODUCTION Patients with chronic kidney disease ( CKD ) show an increase in bowel aerobic bacteria that produce uremic toxins and decreased anaerobic bacteria as bifidobacteria and lactobacillus . The latter can be used as probiotics . The probiotic with greater availability in Mexico , is the lactobacillus casei shirota ( LcS ) , currently there is no known LcS specified dose that produces a benefit to the patient with CKD . OBJECTIVE To determine the effectiveness of two different LcS doses in achieving a decrease in urea concentrations of at least 10 % in patients with KDOQI stage 3 and stage 4 CKD . METODOLOGY : A simple r and omized , controlled clinical trial . Out patients treated at the National Institute of Medical Sciences and Nutrition Salvador Zubirán in México D.F. Patients were provided the LcS , as follows : Group A : 8 x 10(9 ) colony-forming units ( CFU ) and Group B : 16 x 10(9 ) CFU . Patients were followed-up for eight weeks , and baseline and final sample s were obtained to calculate the basal and final concentrations , respectively , of blood urea and serum creatinine ( CrS ) . During the follow-up , both groups consumed a diet of 30 kcal/kg/weight and 0.8 g/kg/weight of protein , and a food diary was made to assess both the adherence to the diet  and  LcS.  RESULTS Thirty patients with CKD were evaluated . When analyzing the percentage change between the different doses , a decrease > 10 % was found in the blood urea concentrations for patients treated with the 16 x 109 dose , which was significant with respect to the baseline measurement . CONCLUSION There was a > 10 % decrease in the serum urea concentrations with LcS in patients with stage 3 and 4 CRF Background Emerging evidence suggests modulating the microbiota in the large bowel of patients with chronic kidney disease ( CKD ) through pre- and /probiotic supplementation may inhibit the development of key nephrovascular toxins . To date , quality intervention trials investigating this novel treatment in CKD are lacking . The aim of SYNERGY is to assess the effectiveness of synbiotics ( co-administration of pre- and probiotics ) as a potential treatment targeting the synthesis of uremic toxins , specifically , indoxyl sulphate ( IS ) and p-cresyl sulphate ( PCS ) . Methods / design Thirty-seven patients with moderate to severe CKD ( Stage IV and V , pre-dialysis ) will be recruited to a double-blind , placebo-controlled , r and omised cross-over trial . Patients will be provided with synbiotic therapy or placebo for 6 weeks , with a 4 week washout before cross-over . The primary outcome is serum IS , total and free ( unbound ) concentrations , measured using ultra-performance liquid chromatography . Secondary outcomes include serum PCS , total and free ( unbound ) concentrations ; cardiovascular risk , measured by serum lipopolysaccharides , serum trimethylamine-N-oxide ( TMAO ) and inflammation and oxidative stress markers ; kidney damage , measured by 24 hour proteinuria and albuminuria , estimated glomerular filtration rate and renal tubule damage ( urinary kidney injury molecule-1 ) ; patients ’ self assessed quality of life ; and gastrointestinal symptoms . In addition , the effects on the community structure of the stool microbiota will be explored in a subset of patients to vali date the mechanistic rationale underpinning the synbiotic therapy . Discussion IS and PCS are two novel uremic toxins implicated in both cardiovascular disease ( CVD ) and progression of CKD . Preliminary studies indicate that synbiotic therapy maybe a promising strategy when considering a targeted , tolerable and cost-efficient therapy for lowering serum IS and PCS concentrations . This trial will provide high quality ‘ proof-of-concept ’ data to eluci date both the efficacy of synbiotic therapy for lowering the toxins and whether reductions in serum IS and PCS translate into clinical benefits . Considering the potential of pre- and probiotics to not only shift toxin levels , but to also impede CVD and CKD progression , SYNERGY will provide vital insight into the effectiveness of this innocuous nutritional therapy . Trial Registration Universal Trial Number : U1111 - 1142 - 4363 . Australian New Zeal and Clinical Trials Registry Number : ACTRN12613000493741 , date registered : 2nd May 2013 OBJECTIVE The objective of the study was to evaluate the effects of probiotic supplementation on the gut microbiota profile and inflammatory markers in chronic kidney disease patients undergoing maintenance hemodialysis ( HD ) . DESIGN AND METHODS This was a r and omized , double-blind , placebo-controlled study . Forty-six HD patients were assigned to receive 1 of 2 treatments : probiotic ( n = 23 ; Streptococcus thermophilus , Lactobacillus acidophilus e Bifidobacterialongum , 90 billion colony-forming units per day ) or placebo ( n = 23 ) daily for 3 months . Blood and feces were collected at baseline and after intervention . The inflammatory markers ( C-reactive protein and interleukin-6 ) were analyzed by immunoenzymatic assay ( enzyme-linked immunosorbent assay ) . Uremic toxins plasma levels ( indoxyl sulfate , p-cresyl sulfate , and indole-3-acetic acid ) were obtained by Reversed-Phase High-Performance Liquid Chromatography . Routine laboratory parameters were measured by st and ard techniques . Fecal pH was measured by the colorimetric method , and the gut microbiota profile was assessed by Denaturing Gradient Gel Electrophoresis analysis . RESULTS Sixteen patients remained in the probiotic group ( 11 men , 53.6 ± 11.0 year old , 25.3 ± 4.6 kg/m2 ) and 17 in the placebo group ( 10 men , 50.3 ± 8.5 year old , 25.2 ± 5.7 kg/m2 ) . After probiotic supplementation there was a significant increase in serum urea ( from 149.6 ± 34.2 mg/dL to 172.6 ± 45.0 mg/dL , P = .02 ) , potassium ( from 4.4 ± 0.4 mmol/L to 4.8 ± 0.4 mmol/L , P = .02 ) , and indoxyl sulfate ( from 31.2 ± 15.9 to 36.5 ± 15.0 mg/dL , P = .02 ) . The fecal pH was reduced from 7.2 ± 0.8 to 6.5 ± 0.5 ( P = .01 ) . These parameters did not change significantly in placebo group . Changes in the percentage delta ( Δ ) between groups were exhibited with no statistical differences observed . The inflammatory markers and gut profile were not altered by supplementation . CONCLUSIONS Aprobiotic supplementation failed to reduce uremic toxins and inflammatory markers . Therefore , probiotic therapy should be chosen with caution in HD patients . Further studies addressing probiotic therapy in chronic kidney disease patients are needed Inflammatory markers such as interleukin (IL)-6 and tumour necrosis factor-alpha ( TNF-α ) are elevated in dialysis patients and can predict cardiovascular events and all-cause mortality . Endotoxin is an important source and also another marker of inflammation in patients with chronic kidney disease . The aim of this study was to evaluate the impact of oral probiotics on serum levels of endotoxemia and cytokines in peritoneal dialysis ( PD ) patients . The decline of residual renal function , peritonitis episodes , and cardiovascular events were also recorded . From July 2011 to June 2012 , a r and omised , double-blind , placebo-controlled trial was conducted in PD patients . The intervention group received one capsule of probiotics containing 10(9 ) cfu Bifobacterium bifidum A218 , 10(9 ) cfu Bifidobacterium catenulatum A302 , 10(9 ) cfu Bifidobacterium longum A101 , and 10(9 ) cfu Lactobacillus plantarum A87 daily for six months , while the placebo group received similar capsules containing maltodextrin for the same duration . Levels of serum TNF-α , interferon gamma , IL-5 , IL-6 , IL-10 , IL-17 , and endotoxin were measured before and six months after intervention . 39 patients completed the study ( 21 in the probiotics group and 18 in the placebo group ) . In patients receiving probiotics , levels of serum TNF-α , IL-5 , IL-6 , and endotoxin significantly decreased after six months of treatment , while levels of serum IL-10 significantly increased . In contrast , there were no significant changes in levels of serum cytokines and endotoxin in the placebo group after six months . In addition , the residual renal function was preserved in patients receiving probiotics . In conclusion , probiotics could significantly reduce the serum levels of endotoxin , pro-inflammatory cytokines ( TNF-α and IL-6 ) , IL-5 , increase the serum levels of anti-inflammatory cytokine ( IL-10 ) , and preserve residual renal function in PD patients 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 : Purpose of review This review summarizes the clinical efficacy of probiotics and prebiotics in gastrointestinal disorders and examines the mechanisms of action related to their therapeutic effect . Recent findings The demonstration that immune and epithelial cells can discriminate between different microbial species has extended the known mechanism(s ) of action of probiotics beyond simple barrier and antimicrobial effects . It has also confirmed that probiotic bacteria modulate mucosal and systemic immune activity and epithelial function . The progressive unraveling of these mechanisms of action has led to new credence for the use of probiotics and prebiotics in clinical medicine . Level I evidence now exists for the therapeutic use of probiotics in infectious diarrhea in children , recurrent Clostridium difficile – induced infections and postoperative pouchitis . Level II evidence is emerging for the use of probiotics in other gastrointestinal infections , prevention of postoperative bacterial translocation , irritable bowel syndrome , and in both ulcerative colitis and Crohn disease . Nevertheless , one consistent feature has emerged over the past year : Not all probiotic bacteria have similar therapeutic effects . Future clinical trials will need to incorporate this fact into trial planning and design . Summary The use of probiotics and prebiotics as therapeutic agents for gastrointestinal disorders is rapidly moving into the “ mainstream . ” Mechanisms of action explain the therapeutic effects and r and omized ; controlled trials provide the necessary evidence for their incorporation into the therapeutic armamentarium Gastrointestinal ( GI ) symptoms and irritable bowel ( IB ) symptoms have been associated with chronic fatigue syndrome/myalgic encephalomyelitis ( CFS/ME ) . The aim of this study was to conduct a systematic review of these symptoms in CFS/ME , along with any evidence for probiotics as treatment . Pubmed , Scopus , Medline ( EBSCOHost ) and EMBASE data bases were search ed to source relevant studies for CFS/ME . The review included any studies examining GI symptoms , irritable bowel syndrome ( IBS ) and /or probiotic use . Studies were required to report criteria for CFS/ME and study design , intervention and outcome measures . Quality assessment was also completed to summarise the level of evidence available . A total of 3381 publications were returned using our search terms . Twenty-five studies were included in the review . R and omised control trials were the predominant study type ( n = 24 ) . Most of the studies identified examined the effect of  probiotic supplementation on the improvement of IB symptoms in IBS patients , or IB symptoms in CFS/ME patients , as well as some other significant secondary outcomes ( e.g. quality of life , other gastrointestinal symptoms , psychological symptoms ) . The level of evidence identified for the use of  probiotics  in IBS was excellent in quality ; however , the evidence available for the use of probiotic interventions in CFS/ME was poor and limited . There is currently insufficient evidence for the use of probiotics in CFS/ME patients , despite probiotic interventions being useful in IBS . The studies pertaining to probiotic interventions in CFS/ME patients were limited and of poor quality overall . St and ardisation of protocol s and methodology in these studies is required 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 The purpose of this study was to evaluate the efficacy and safety of commonly used probiotics and nutrients available for functional gastrointestinal disorders ( FGID ) . Five different combinations of probiotics and nutrients , or placebo , were taken daily over 12 weeks . In this r and omized controlled clinical trial , men and women 21 to 72 years of age with FGID symptoms of indigestion , bloating , and abdominal discomfort were assigned to one of six groups , 12 patients per group .  Gastrointestinal Quality of Life Index ( GIQLI ) and visual analogue scale ( VAS ) for GI symptoms , SF-36 , lactulose and mannitol test ( LMT ) , and urine indican levels were evaluated . GIQLI , VAS scores , and LMT did not change significantly ( P > 0.05 ) . There were clinical ly notable improvements in two of the combination formulations . While the nonsignificant improvements in GI symptoms could suggest that combination probiotics and nutrients may be beneficial in conditions such as FGID , no conclusive evidence was found in this pilot trial . Further investigations to explore the findings are discussed Purpose To study the therapeutic effects of probiotic Escherichia coli Nissle 1917 ( EcN ) in irritable bowel syndrome ( IBS ) and identify subgroups benefiting most . Background Some trials investigating therapeutic effects in irritable bowel syndrome have shown benefits in IBS subgroups only . Probiotic treatment seems to be promising . Methods Patients with irritable bowel syndrome ( 120 ; Rome II ) were recruited to a prospect i ve double-blind study and r and omized to either EcN ( n = 60 ) or placebo ( n = 60 ) given for 12 weeks . Objectives were to describe efficacy and safety of EcN  in different groups of irritable bowel syndrome . Outcome was assessed by ‘ Integrative Medicine Patient Satisfaction Scale ’ . Results Altogether , the responder rate was higher in the EcN than in the placebo group . However , only after 10 and 11 weeks , the differences were significant ( Δ 20.0 % points [ 95 % CI 2.6 ; 37.4 ] , p = 0.01 and Δ 18.3 % points [ 95 % CI 1.0 ; 35.7 ] , p = 0.02 , respectively ) . The best response was observed in the subgroup of patients with gastroenteritis or antibiotics prior to irritable bowel syndrome onset ( Δ 45.7 % points , p = 0.029 ) . No significant differences were observed in any other subgroup . Both treatment groups showed similar adverse events and tolerance . Conclusions Probiotic EcN  shows effects in irritable bowel syndrome , especially in patients with altered enteric microflora , e.g. after gastroenterocolitis or administration of antibiotics BACKGROUND Micro-inflammation is considered an element in the pathogenesis of irritable bowel syndrome ( IBS ) . High-sensitivity C reactive protein ( hs-CRP ) was previously shown to be higher in IBS compared to healthy controls , albeit within the normal range . Since probiotics may suppress micro-inflammation in the gut , we tested if they reduce symptoms and inflammatory markers ( hs-CRP and fecal calprotectin ( FC ) in diarrhea-predominant IBS ( IBS-D ) . The aim of this study was to assess the clinical and laboratory effects of BIO-25 , a multispecies probiotic , in women with IBS-D. METHODS A double-blind , placebo-controlled study . Following a 2-week run-in , eligible women were assigned at r and om to a probiotic capsule or an indistinguishable placebo , twice daily for 8 weeks . IBS symptoms and stool consistency were rated daily by Visual Analogue Scales ( VAS ) and the Bristol Stool Scale ( BSS ) . High-sensitivity C reactive protein was tested at baseline , 4 and 8 weeks . FC was tested at baseline and 8 weeks . KEY RESULTS One hundred and seventy-two IBS-D patients were recruited and 107 eligible patients were allocated to the  intervention  ( n=54 ) or placebo  ( n=53 ) group . All symptoms improved in both groups with no significant difference between them in symptom improvement , hs-CRP or FC levels . CONCLUSIONS & INFERENCES An 8-week treatment with BIO-25 improved symptoms in women with IBS-D , but was not superior to placebo . This rigorously design ed and executed study supports the findings of other studies that did not demonstrate superiority of probiotics over placebo in IBS . High quality clinical studies are necessary to examine the efficacy of other specific probiotics in IBS-D patients since data are still conflicting We assessed the effect of multi-species probiotic mixture on the changes in fecal microbiota and irritable bowel syndrome ( IBS ) symptoms . Eighty-one IBS patients were r and omly assigned to receive either probiotic mixture ( n = 39 ; containing Lactobacillus acidophilus , L. rhamnosus , Bifidobacterium breve , B. actis , B. longum , and Streptococcus thermophilus ) or placebo ( n = 42 ) for 4 weeks . A question naire regarding general symptom relief was administered . The change in total symptom scores ( sum of 10 IBS symptoms ) and subtotal scores in 4 domains ( pain , constipation , diarrhea , and bloating/gas ) were evaluated . The change in fecal flora was determined by quantitative real-time PCR . The concentration of probiotic strains significantly increased after ingestion in probiotics group ( B. bifidum , p = 0.043 ; B. lactis , p<0.001 ; L. acidophilus , p = 0.016 ; L. rhamnosus , p<0.001 ) . The proportion of patients with adequate symptom relief was higher in probiotics group than in placebo group ( 74.4 % vs 61.9 % , p = 0.230 ) . The decrease in total symptom score over time was not significantly different between the groups ( p = 0.703 ) . Among subtotal scores of 4 IBS symptom domains , the time effect was significantly different for diarrhea-symptom score between the groups ( p = 0.017 ) . A 4-week administration of multi-species probiotic mixture significantly increased the fecal concentration of most probiotic strains and improved diarrhea-symptom scores in IBS patients Background / Aims Irritable bowel syndrome ( IBS ) is a troublesome disease . Some strains of probiotics reportedly exert remarkable immunomodulatory effects , and so we design ed a prospect i ve double-blind r and omized placebo-controlled clinical study to assess their effects in Korean adults with IBS . Methods IBS patients who met Rome III criteria were r and omly assigned to receive composite probiotics or placebo . A total of 20 billion lyophilized bacteria were administered twice daily for 8 weeks . Primary outcome variables were symptom scores consisting of abdominal pain , flatulence , defecation discomfort , and sum of symptom scores . A visual analogue scale was used to quantify the severity . Secondary outcome variables consisted of the quality of life and bowel habits including defecation frequency and stool form . Results Thirty-six and 34 patients were r and omized to the probiotics and placebo groups , respectively . Intention-to-treat analysis showed significant reductions in pain after 8 weeks of treatment : -31.9 and -17.7 in the probiotics and placebo groups , respectively ( p=0.045 ) . The reductions in abdominal pain , defecation discomfort , and sum of scores were more significant in 58 patients with a score of at least 3 on the baseline stool-form scale . Conclusions Composite probiotics containing Bifidobacterium bifidum BGN4 , Lactobacillus acidophilus AD031 , and other species are safe and effective , especially in patients who excrete normal or loose stools Background The beneficial effect of probiotics on renal profile and liver function has been reported among patients with chronic kidney disease and fatty liver respectively . However , its effect on renal profile and liver function among type 2 diabetic individuals has not been fully understood . To investigate the effect of microbial cell preparation on renal profile and liver function tests among type 2 diabetic individuals . Methods A r and omized , double-blind , parallel-group , controlled clinical trial was conducted on a total of 136 type 2 diabetics age 30 - 70 years old in a teaching hospital in Kuala Lumpur , Malaysia . Subjects were r and omly assigned to receive microbial cell preparation ( N = 68 ) or a placebo ( N = 68 ) for 12 weeks . The outcomes measured at baseline , week 6 , and week 12 and included changes in renal profile ( Sodium , Potassium , Urea , Creatinine , Glomerular Filtration Rate ) , and liver function tests ( Albumin , Total Protein , Alkaline Phosphatase , Alanine Aminotransferase , Aspartate Aminotransferase ) . Intention to treat ( ITT ) analysis was performed on all the recruited subjects , while per protocol ( PP ) analysis was conducted on those who completed the trial with good compliance . Result The urea levels significantly declined in the probiotic group . Serum urea levels reduced from 4.26 mmol/L to 4.04 mmol/L in Probiotic Group while it increased in Placebo Group from 4.03 mmol/L to 4.24 mmol/L. These changes were significant between groups in ITT analysis ( p = 0.018 ) . Other parameters did not change significantly between groups . Conclusion 12 weeks supplementation with daily dosage of 6 × 1010 Colony Forming Units of multi-strain microbial cell preparation significantly improved urea levels . Trial registration ( Clinical trials : # NCT01752803
Conclusion Our study demonstrates potential beneficial effects of probiotics on inflammation , uremic toxins , and GI Symptoms in ESRD patients .
Background / Objectives We performed this systematic review and meta- analysis to evaluate effects of probiotics on inflammation , uremic toxins , and gastrointestinal ( GI ) symptoms in end-stage renal disease ( ESRD ) patients .