human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background Increased exposure to intestinal bacterial products may contribute to the pathogenesis of non alcoholic steatohepatitis ( NASH ) . Bifidobacteria are predominant bacterial species in the human gut microbiota and have been considered to exert a beneficial effect on human health by maintaining the equilibrium of the resident microbiota . Aims To evaluate the effects of Bifidobacterium longum with fructo-oligosaccharides ( Fos ) in the treatment of NASH . Methods A total of 66 patients were r and omly and equally divided into two groups receiving Bifidobacterium longum with Fos and lifestyle modification ( i.e. , diet and exercise ) versus lifestyle modification alone . The following variables were assessed at −4 ( beginning of the dietary lead-in period ) , 0 ( r and omization ) , 6 , 12 , 18 , and 24 weeks : aspartate transaminase ( AST ) , alanine transaminase ( ALT ) , bilirubin , albumin , total cholesterol , high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , triglycerides , fasting plasma glucose , insulin , C-peptide , C-reactive protein ( CRP ) , tumor necrosis factor (TNF)-α , homeostasis model assessment of insulin resistance ( HOMA-IR ) , and serum endotoxins . Liver biopsies were performed at entry and repeated after 24 weeks of treatment . Results At the end of study period , we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the AST −69.6 versus −45.9 IU/mL ( P < 0.05 ) , LDL cholesterol −0.84 versus −0.18 mmol/L ( P < 0.001 ) , CRP −2.9 versus −0.7 mg/L ( P < 0.05 ) , TNF-α −0.45 versus −0.12 ng/mL ( P < 0.001 ) , HOMA-IR −1.1 versus −0.6 ( P < 0.001 ) , serum endotoxin −45.2 versus −30.6 pg/mL ( P < 0.001 ) , steatosis ( P < 0.05 ) , and the NASH activity index ( P < 0.05 ) . Conclusions Bifidobacterium longum with Fos and lifestyle modification , when compared to lifestyle modification alone , significantly reduces TNF-α , CRP , serum AST levels , HOMA-IR , serum endotoxin , steatosis , and the NASH activity index 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 BACKGROUND Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in the world . Oral administration of synbiotic has been proposed as an effective treatment of NAFLD because of its modulating effect on the gut flora , which can influence the gut-liver axis . OBJECTIVE The objective was to evaluate the effects of supplementation with synbiotic on hepatic fibrosis , liver enzymes , and inflammatory markers in patients with NAFLD . DESIGN In a r and omized , double-blind , placebo-controlled clinical trial conducted as a pilot study , 52 patients with NAFLD were supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule . Both groups were advised to follow an energy-balanced diet and physical activity recommendations . RESULTS At the end of the study , the alanine aminotransferase ( ALT ) concentration decreased in both groups ; this reduction was significantly greater in the synbiotic group . At the end of the study , the following significant differences [ means ( 95 % CIs ) ] were seen between the synbiotic and placebo groups , respectively : ALT [ -25.1 ( -26.2 , -24 ) compared with -7.29 ( -9.5 , -5.1 ) IU/L ; P < 0.001 ] , aspartate aminotransferase [ -31.33 ( -32.1 , -30.5 ) compared with -7.94 ( -11.1 , -4.8 ) IU/L ; P < 0.001 ] , γ-glutamyltransferase [ -15.08 ( -15.5 , -14.7 ) compared with -5.21 ( -6.6 , -3.9 ) IU/L ; P < 0.001 ] , high-sensitivity C-reactive protein [ -2.3 ( -3 , -1.5 ) compared with -1.04 ( -1.5 , -0.6 ) mmol/L ; P < 0.05 ] , tumor necrosis factor-α [ -1.4 ( -1.7 , -1.1 ) compared with -0.59 ( -0.8 , -0.3 ) mmol/L ; P < 0.001 ] , total nuclear factor κ-B p65 [ -0.016 ( -0.022 , -0.011 ) compared with 0.001 ( -0.004 , -0.007 ) mmol/L ; P < 0.001 ] , and fibrosis score as determined by transient elastography [ - 2.98 ( -3.6 , -2.37 ) compared with -0.77 ( -1.32 , -0.22 ) kPa ; P < 0.001 ] . CONCLUSIONS Synbiotic supplementation in addition to lifestyle modification is superior to lifestyle modification alone for the treatment of NAFLD , at least partially through attenuation of inflammatory markers in the body . Whether these effects will be sustained with longer treatment duration s remains to be determined BACKGROUND Gut flora is related to the major complications of liver cirrhosis including hepatic encephalopathy , spontaneous bacterial peritonitis , and variceal bleeding . Prior studies have reported a beneficial effect of gut flora modification with probiotic bacteria in patients with minimal hepatic encephalopathy . We aim ed to study the effect of probiotics on clinical and laboratory parameters of patients with compensated cirrhosis . METHODS A double-blind placebo-controlled study that included patients with liver cirrhosis and at least one major complication of cirrhosis in the past , clinical evidence of portal hypertension , or decreased hepatic synthetic function . Participants were r and omly assigned to receive probiotic capsules containing Lactobacillus acidophilus , Lactobacillus bulgaricus , Bifidobacterium lactis , and Streptococcus thermophiles or placebo for a period of 6 mo . RESULTS A total of 36 patients were available for final analysis ( distributed equally between the probiotic and placebo groups ) . The administration of probiotics was not associated with significant differences in either clinical or laboratory parameters between the two groups . Because the lack of a beneficial effect may be related to the compensated liver disease of patients , we conducted a sub analysis of patients with baseline ammonia levels > 50 mmol/L. In this subgroup , the administration of probiotics appeared to significantly reduce the ammonia levels starting after 1 mo of treatment . However , this effect diminished and lost its significance following comparison to the placebo group . CONCLUSIONS Our study did not show a significant beneficial effect of probiotic supplementation in patients with compensated liver cirrhosis . Nevertheless , it points toward a possible positive effect of probiotics in patients with above normal baseline ammonia levels . This issue requires further investigation in larger cohorts Abstract Bacillus subtilis CU1 is a recently described probiotic strain with beneficial effects on  immune health in elderly subjects . The following work describes a series of studies supporting the safety of the strain for use as an ingredient in food and supplement preparations . Using a combination of 16S rDNA and gyrB nucleotide analyses , the species was identified as a member of the Bacillus subtilis complex ( B. subtilis subsp . spizizenii ) . Further characterization of the organism at the strain level was achieved using r and om amplified polymorphic DNA polymerase chain reaction ( RAPD PCR ) and pulsed field gel electrophoresis ( PFGE ) analyses . B. subtilis CU1 did not demonstrate antibiotic resistance greater than existing regulatory cutoffs against clinical ly important antibiotics , did not induce hemolysis or produce surfactant factors , and was absent of toxigenic activity in vitro . Use of B. subtilis CU1 as a probiotic has recently been evaluated in a 16‐week r and omized , double‐blind , placebo‐controlled , parallel‐arm study , in which 2 × 109 spores per day of B. subtilis CU1 were administered for a total 40 days to healthy elderly subjects ( 4 consumption periods of 10 days separated by 18‐day washouts ) . This work describes safety related endpoints not previously reported . B. subtilis CU1 was safe and well‐tolerated in the clinical subjects without undesirable physiological effects on markers of liver and kidney function , complete blood counts , hemodynamic parameters , and vital signs . HighlightsA safety assessment of the probiotic Bacillus subtilis CU1 was conducted . Genomic analyses identified the species as a member of the B. subtilis complex . Antibiotic resistance was not observed at levels exceeding regulatory cut‐offs . B. subtilis CU1 was absent of toxigenic activity in vitro . B. subtilis CU1 was safely consumed ( 2 × 109 spores/day ) by all clinical subjects Probiotic supplementation may provide health benefits , especially for individuals with an underlying disease state that makes them more susceptible to infections . The purpose of this experiment was to evaluate the safety and tolerance of Lactobacillus reuteri ingestion by subjects infected with the human immunodeficiency virus ( HIV ) . Thirty-nine subjects consumed a freeze-dried preparation of L. reuteri or a placebo for 21 days in a double-masked , parallel design experiment . Serum chemistry , haematology , immune profile , urinalysis , physical examination , gastrointestinal tolerance and faecal microbiota data were collected . No clinical ly significant changes were noted in any of the safety parameters measured . Overall , tolerance was good in both groups . Consumption of L. reuteri tended to increase faecal levels of L. reuteri on days 7 , 14 and 21 of treatment feeding ( P < 0.06 , P < 0.11 and P = 0.05 , respectively ) . However , faecal levels of L. reuteri and total Lactobacillus species were lower than levels previously observed in healthy male adults . Overall , this study documents that L. reuteri may be fed to HIV-positive individuals at 1 x 10(10 ) colony forming units/day without any clinical ly significant safety or tolerance problems OBJECTIVE To evaluate the efficacy of low carbohydrate diet ( LCD ) as compared with low fat diet ( LFD ) to decrease aminotransferase levels in obese women with nonalcoholic fatty liver disease . MATERIAL AND METHODS A total of 59 women were r and omly enrolled in a non-controlled clinical intervention study to receive either LCD or LFD during six months . Apparently healthy non-pregnant obese women aged 20 to 65 years were eligible to participate . Previous diagnosis of hepatic disease , serum creatinine level ≥ 1.5 mg/dL , severe life-limiting medical illness , pregnancy , active participation in other dietary program , use of weight loss drugs , or alcohol consumption ≥ 30 g per day were exclusion criteria . RESULTS A total of 31 obese women who received LCD were compared with 28 women allocated in the LFD group . There were 3 ( LCD group ) and  
    Output:
    
agent
Subgroup analysis suggested the existence of liver disease at baseline , synbiotics supplementation and duration of supplementation ≥ 8 weeks result ed in more pronounced improvement in liver function enzymes than their counterparts .
Conclusions Probiotics and synbiotics may be suggested as supplements to improve serum concentration of liver enzymes , especially when synbiotics administered for a period ≥ 8 weeks and in individuals with liver disease
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background Increased exposure to intestinal bacterial products may contribute to the pathogenesis of non alcoholic steatohepatitis ( NASH ) . Bifidobacteria are predominant bacterial species in the human gut microbiota and have been considered to exert a beneficial effect on human health by maintaining the equilibrium of the resident microbiota . Aims To evaluate the effects of Bifidobacterium longum with fructo-oligosaccharides ( Fos ) in the treatment of NASH . Methods A total of 66 patients were r and omly and equally divided into two groups receiving Bifidobacterium longum with Fos and lifestyle modification ( i.e. , diet and exercise ) versus lifestyle modification alone . The following variables were assessed at −4 ( beginning of the dietary lead-in period ) , 0 ( r and omization ) , 6 , 12 , 18 , and 24 weeks : aspartate transaminase ( AST ) , alanine transaminase ( ALT ) , bilirubin , albumin , total cholesterol , high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , triglycerides , fasting plasma glucose , insulin , C-peptide , C-reactive protein ( CRP ) , tumor necrosis factor (TNF)-α , homeostasis model assessment of insulin resistance ( HOMA-IR ) , and serum endotoxins . Liver biopsies were performed at entry and repeated after 24 weeks of treatment . Results At the end of study period , we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the AST −69.6 versus −45.9 IU/mL ( P < 0.05 ) , LDL cholesterol −0.84 versus −0.18 mmol/L ( P < 0.001 ) , CRP −2.9 versus −0.7 mg/L ( P < 0.05 ) , TNF-α −0.45 versus −0.12 ng/mL ( P < 0.001 ) , HOMA-IR −1.1 versus −0.6 ( P < 0.001 ) , serum endotoxin −45.2 versus −30.6 pg/mL ( P < 0.001 ) , steatosis ( P < 0.05 ) , and the NASH activity index ( P < 0.05 ) . Conclusions Bifidobacterium longum with Fos and lifestyle modification , when compared to lifestyle modification alone , significantly reduces TNF-α , CRP , serum AST levels , HOMA-IR , serum endotoxin , steatosis , and the NASH activity index 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 BACKGROUND Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in the world . Oral administration of synbiotic has been proposed as an effective treatment of NAFLD because of its modulating effect on the gut flora , which can influence the gut-liver axis . OBJECTIVE The objective was to evaluate the effects of supplementation with synbiotic on hepatic fibrosis , liver enzymes , and inflammatory markers in patients with NAFLD . DESIGN In a r and omized , double-blind , placebo-controlled clinical trial conducted as a pilot study , 52 patients with NAFLD were supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule . Both groups were advised to follow an energy-balanced diet and physical activity recommendations . RESULTS At the end of the study , the alanine aminotransferase ( ALT ) concentration decreased in both groups ; this reduction was significantly greater in the synbiotic group . At the end of the study , the following significant differences [ means ( 95 % CIs ) ] were seen between the synbiotic and placebo groups , respectively : ALT [ -25.1 ( -26.2 , -24 ) compared with -7.29 ( -9.5 , -5.1 ) IU/L ; P < 0.001 ] , aspartate aminotransferase [ -31.33 ( -32.1 , -30.5 ) compared with -7.94 ( -11.1 , -4.8 ) IU/L ; P < 0.001 ] , γ-glutamyltransferase [ -15.08 ( -15.5 , -14.7 ) compared with -5.21 ( -6.6 , -3.9 ) IU/L ; P < 0.001 ] , high-sensitivity C-reactive protein [ -2.3 ( -3 , -1.5 ) compared with -1.04 ( -1.5 , -0.6 ) mmol/L ; P < 0.05 ] , tumor necrosis factor-α [ -1.4 ( -1.7 , -1.1 ) compared with -0.59 ( -0.8 , -0.3 ) mmol/L ; P < 0.001 ] , total nuclear factor κ-B p65 [ -0.016 ( -0.022 , -0.011 ) compared with 0.001 ( -0.004 , -0.007 ) mmol/L ; P < 0.001 ] , and fibrosis score as determined by transient elastography [ - 2.98 ( -3.6 , -2.37 ) compared with -0.77 ( -1.32 , -0.22 ) kPa ; P < 0.001 ] . CONCLUSIONS Synbiotic supplementation in addition to lifestyle modification is superior to lifestyle modification alone for the treatment of NAFLD , at least partially through attenuation of inflammatory markers in the body . Whether these effects will be sustained with longer treatment duration s remains to be determined BACKGROUND Gut flora is related to the major complications of liver cirrhosis including hepatic encephalopathy , spontaneous bacterial peritonitis , and variceal bleeding . Prior studies have reported a beneficial effect of gut flora modification with probiotic bacteria in patients with minimal hepatic encephalopathy . We aim ed to study the effect of probiotics on clinical and laboratory parameters of patients with compensated cirrhosis . METHODS A double-blind placebo-controlled study that included patients with liver cirrhosis and at least one major complication of cirrhosis in the past , clinical evidence of portal hypertension , or decreased hepatic synthetic function . Participants were r and omly assigned to receive probiotic capsules containing Lactobacillus acidophilus , Lactobacillus bulgaricus , Bifidobacterium lactis , and Streptococcus thermophiles or placebo for a period of 6 mo . RESULTS A total of 36 patients were available for final analysis ( distributed equally between the probiotic and placebo groups ) . The administration of probiotics was not associated with significant differences in either clinical or laboratory parameters between the two groups . Because the lack of a beneficial effect may be related to the compensated liver disease of patients , we conducted a sub analysis of patients with baseline ammonia levels > 50 mmol/L. In this subgroup , the administration of probiotics appeared to significantly reduce the ammonia levels starting after 1 mo of treatment . However , this effect diminished and lost its significance following comparison to the placebo group . CONCLUSIONS Our study did not show a significant beneficial effect of probiotic supplementation in patients with compensated liver cirrhosis . Nevertheless , it points toward a possible positive effect of probiotics in patients with above normal baseline ammonia levels . This issue requires further investigation in larger cohorts Abstract Bacillus subtilis CU1 is a recently described probiotic strain with beneficial effects on  immune health in elderly subjects . The following work describes a series of studies supporting the safety of the strain for use as an ingredient in food and supplement preparations . Using a combination of 16S rDNA and gyrB nucleotide analyses , the species was identified as a member of the Bacillus subtilis complex ( B. subtilis subsp . spizizenii ) . Further characterization of the organism at the strain level was achieved using r and om amplified polymorphic DNA polymerase chain reaction ( RAPD PCR ) and pulsed field gel electrophoresis ( PFGE ) analyses . B. subtilis CU1 did not demonstrate antibiotic resistance greater than existing regulatory cutoffs against clinical ly important antibiotics , did not induce hemolysis or produce surfactant factors , and was absent of toxigenic activity in vitro . Use of B. subtilis CU1 as a probiotic has recently been evaluated in a 16‐week r and omized , double‐blind , placebo‐controlled , parallel‐arm study , in which 2 × 109 spores per day of B. subtilis CU1 were administered for a total 40 days to healthy elderly subjects ( 4 consumption periods of 10 days separated by 18‐day washouts ) . This work describes safety related endpoints not previously reported . B. subtilis CU1 was safe and well‐tolerated in the clinical subjects without undesirable physiological effects on markers of liver and kidney function , complete blood counts , hemodynamic parameters , and vital signs . HighlightsA safety assessment of the probiotic Bacillus subtilis CU1 was conducted . Genomic analyses identified the species as a member of the B. subtilis complex . Antibiotic resistance was not observed at levels exceeding regulatory cut‐offs . B. subtilis CU1 was absent of toxigenic activity in vitro . B. subtilis CU1 was safely consumed ( 2 × 109 spores/day ) by all clinical subjects Probiotic supplementation may provide health benefits , especially for individuals with an underlying disease state that makes them more susceptible to infections . The purpose of this experiment was to evaluate the safety and tolerance of Lactobacillus reuteri ingestion by subjects infected with the human immunodeficiency virus ( HIV ) . Thirty-nine subjects consumed a freeze-dried preparation of L. reuteri or a placebo for 21 days in a double-masked , parallel design experiment . Serum chemistry , haematology , immune profile , urinalysis , physical examination , gastrointestinal tolerance and faecal microbiota data were collected . No clinical ly significant changes were noted in any of the safety parameters measured . Overall , tolerance was good in both groups . Consumption of L. reuteri tended to increase faecal levels of L. reuteri on days 7 , 14 and 21 of treatment feeding ( P < 0.06 , P < 0.11 and P = 0.05 , respectively ) . However , faecal levels of L. reuteri and total Lactobacillus species were lower than levels previously observed in healthy male adults . Overall , this study documents that L. reuteri may be fed to HIV-positive individuals at 1 x 10(10 ) colony forming units/day without any clinical ly significant safety or tolerance problems OBJECTIVE To evaluate the efficacy of low carbohydrate diet ( LCD ) as compared with low fat diet ( LFD ) to decrease aminotransferase levels in obese women with nonalcoholic fatty liver disease . MATERIAL AND METHODS A total of 59 women were r and omly enrolled in a non-controlled clinical intervention study to receive either LCD or LFD during six months . Apparently healthy non-pregnant obese women aged 20 to 65 years were eligible to participate . Previous diagnosis of hepatic disease , serum creatinine level ≥ 1.5 mg/dL , severe life-limiting medical illness , pregnancy , active participation in other dietary program , use of weight loss drugs , or alcohol consumption ≥ 30 g per day were exclusion criteria . RESULTS A total of 31 obese women who received LCD were compared with 28 women allocated in the LFD group . There were 3 ( LCD group ) and  
    Output:
    