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Although non-alcoholic fatty liver disease (NAFLD) is the leading aetiology of liver disorders in the world, there is no proven treatment for NAFLD patients with normal or low BMI. The aim of this study was to evaluate the efficacy of synbiotics supplementation in NAFLD patients with normal or low BMI. In this randomised, double-blind, placebo-controlled, clinical trial, fifty patients with NAFLD were assigned to take either a synbiotic supplement or a placebo capsule for 28 weeks. Both groups were advised to follow a healthy lifestyle. At the end of the study, hepatic steatosis and fibrosis reduced in both groups; however, the mean reduction was significantly greater in the synbiotic group rather than in the placebo group (P<0·001). Furthermore, serum levels of fasting blood sugar, TAG and most of the inflammatory mediators reduced in the synbiotic group significantly compared with the placebo group (P<0·05). Our results provide evidence that synbiotic supplementation improves the main features of NAFLD in patients with normal and low BMI, at least partially through reduction in inflammatory indices. Further studies are needed to address the exact mechanism of action of these effects.

Background One way to improve both the ecological performance and functionality of probiotic bacteria is by combining them with a prebiotic in the form of a synbiotic. However, the degree to which such synbiotic formulations improve probiotic strain functionality in humans has not been tested systematically. Our goal was to use a randomized, double-blind, placebo-controlled, parallel-arm clinical trial in obese humans to compare the ecological and physiological impact of the prebiotic galactooligosaccharides (GOS) and the probiotic strains Bifidobacterium adolescentis IVS-1 (autochthonous and selected via in vivo selection) and Bifidobacterium lactis BB-12 (commercial probiotic allochthonous to the human gut) when used on their own or as synbiotic combinations. After 3 weeks of consumption, strain-specific quantitative real-time PCR and 16S rRNA gene sequencing were performed on fecal samples to assess changes in the microbiota. Intestinal permeability was determined by measuring sugar recovery in urine by GC after consumption of a sugar mixture. Serum-based endotoxin exposure was also assessed. Results IVS-1 reached significantly higher cell numbers in fecal samples than BB-12 ( P  < 0.01) and, remarkably, its administration induced an increase in total bifidobacteria that was comparable to that of GOS. Although GOS showed a clear bifidogenic effect on the resident gut microbiota, both probiotic strains showed only a non-significant trend of higher fecal cell numbers when administered with GOS. Post-aspirin sucralose:lactulose ratios were reduced in groups IVS-1 ( P  = 0.050), IVS-1 + GOS ( P  = 0.022), and GOS ( P  = 0.010), while sucralose excretion was reduced with BB-12 ( P  = 0.002) and GOS ( P  = 0.020), indicating improvements in colonic permeability but no synergistic effects. No changes in markers of endotoxemia were observed. Conclusion This study demonstrated that “autochthony” of the probiotic strain has a larger effect on ecological performance than the provision of a prebiotic substrate, likely due to competitive interactions with members of the resident microbiota. Although the synbiotic combinations tested in this study did not demonstrate functional synergism, our findings clearly showed that the pro- and prebiotic components by themselves improved markers of colonic permeability, providing a rational for their use in pathologies with an underlying leakiness of the gut.

The aim of this study was to investigate the effects of 24-week synbiotic supplementation on chronic inflammation and the gut microbiota in obese patients with type 2 diabetes. We randomized 88 obese patients with type 2 diabetes to one of two groups for 24 weeks: control or synbiotic (Lacticaseibacillus paracasei strain Shirota (previously Lactobacillus casei strain Shirota) and Bifidobacterium breve strain Yakult, and galactooligosaccharides). The primary endpoint was the change in interleukin-6 from baseline to 24 weeks. Secondary endpoints were evaluation of the gut microbiota in feces and blood, fecal organic acids, high-sensitivity C-reactive protein, lipopolysaccharide-binding protein, and glycemic control. Synbiotic administration for 24 weeks did not significantly affect changes in interleukin-6 from baseline to 24 weeks (0.35 ± 1.99 vs. −0.24 ± 1.75 pg/mL, respectively). Relative to baseline, however, at 24 weeks after synbiotic administration there were positive changes in the counts of Bifidobacterium and total lactobacilli, the relative abundances of Bifidobacterium species such as Bifidobacterium adolescentis and Bifidobacterium pseudocatenulatum, and the concentrations of acetic and butyric acids in feces. No significant changes in inflammatory markers were found in the synbiotic group compared to the control group. However, synbiotic administration at least partially improved the gut environment in obese patients with type 2 diabetes.

•Synbiotics given preoperatively reduced inflammation, antibiotic use, and length of stay in postoperative colorectal cancer patients. Objectives: Gastrointestinal microflora is involved in the development and regulation of the immune response. Non-pathogenic bacteria are important to prevent the development and subsequent invasion of enteropathogenic bacteria. Surgical trauma and intestinal preparation can disrupt the intestinal microbiota balance. Modulating the microbiota in the preoperative period in patients with colorectal cancer may have an effect on the occurrence of postoperative complications. The aim of this study was to assess the effect of preoperative synbiotic administration in patients with colorectal cancer subjected to colorectal resection. Methods: This was a prospective, randomized, double-blind, placebo-controlled study of 73 patients with colorectal cancer. Eight days before surgery, patients were randomized to receive either synbiotics (Simbioflora, Farmoquimica, São Paulo, Brazi) or placebo (maltodextrin). The envelopes were identical and labeled A or B. All patients underwent nutritional assessment and measurements of C-reactive protein (CRP), interleukin (IL)-6, serum albumin, and transferrin. Patients were given a diluted envelope in 100 mL of water twice daily for 7 d. The occurrence of infectious or non-infectious complications, time of antibiotic use, duration of hospitalization, and occurrence of deaths were recorded for 30 d postoperatively. Results: Mean age, demographic data, and tumor staging were similar between the groups at baseline. After 7 d of synbiotic intake, there were significant reductions in IL-6 levels (163.2 ± 19.5 versus 138.8 ± 12.5, P < 0.001) and CRP (10 ± 5.2 versus 7.17 ± 3.2, P < 0.001), whereas the control group did not present significant changes I IL-6 levels (154.2 ± 18.3 versus 160.9 ± 18.6, NS) or CRP (10.6 ± 6.18 versus 10.4 ± 6.1, NS). Serum albumin and transferrin did not show significant changes. Postoperative infectious complications occurred in 2.8% of patients in the synbiotic group and in 18.9% of the control group (P = 0.02). The mean antibiotic usage time was 1.42 ± 0.5 d in the synbiotic group and 3.74 ± 4.3 d in the control group (P < 0.001). The mean hospital length of stay was 3 ± 1 d in the synbiotic group and 4 ± 18 in the control group (P < 0.001). Three deaths were reported in the control group and none in the synbiotic group (P = 0.115). Conclusions: The use of synbiotics for 7 d preoperatively in patients with colorectal cancer attenuates the inflammatory state and is associated with reductions in morbidity, hospital length of stay, and use of antibiotics.

Infant colic is defined as a recurrent and prolonged period of fussing, crying and/or irritability that cannot be prevented or resolved by caregivers. The aim of this study is to evaluate the efficacy of a synbiotic (Bactecal D Liquid) in infants consulting a primary health care professional for inconsolable crying. A randomized trial was conducted in 68 infants diagnosed by the consulted primary health care professional as “probably suffering from infant colic”. Patients were randomized into two groups and given the synbiotic once (group 1) or twice (group 2) a day for 28 days. Quality of life (QoL) of the caregivers, evaluated with a Likert scale, was the primary outcome. Secondary outcomes included the total number of crying episodes, total crying time, gassiness and “balling of the fists”. The median (Q1;Q3) QoL scores were significantly ( p  < 0.001) higher on day 28 than at baseline: 6 (5;7) vs 2 (1;3). At baseline, there was no significant difference ( p  = 0.527) in QoL between both groups. The improvement in QoL was already significant after one week of intervention for both groups. The median number of crying episodes, overall crying time, gassiness and “balling of fists” were significantly lower on day 28 compared to baseline ( p  < 0.001). Conclusion : The synbiotic tested was shown to be efficacious in the management of infant colic. A significant improvement was observed after 7 days of intervention, which is much earlier than the expected decrease related to the natural evolution of infant colic. What is Known: • Some probiotic strains are reported to be effective in the management of infants presenting with colic, if breastfed. What is New: • The synbiotic studied improved quality of life of caregivers of infants presenting infant colic. • Two doses of the synbiotic were not more effective than one dose. • The improved occurred within one week. • The improvement was independent of feeding (breastfeeding, formula feeding or mixed feeding).

The purpose of the randomized double-blind placebo-controlled trial was to assess the effectiveness of synbiotic preparation containing probiotic Lactobacillus rhamnosus FloraActive™ 19070-2, Lactobacillus acidophilus DSMZ 32418, Bifidobacterium lactis DSMZ 32269, Bifidobacterium longum DSMZ 32946, Bifidobacterium bifidum DSMZ 32403 and fructooligosaccharides in adult patients with diarrhea-dominant IBS (IBS-D). The study included eighty patients with moderate and severe IBS-D who were randomized to receive synbiotics or placebo for eight weeks. Finally, a total of sixty-eight patients finished the study. The primary endpoints included the assessment of the symptoms’ severity with IBS symptom severity scale (IBS-SSS), an improvement of IBS global symptoms with Global Improvement Scale (IBS-GIS) and adequate relief of symptoms after four and eight weeks of therapy. Secondary endpoints, which were collected by telephone interviewers three times a week included the assessment of individual IBS symptoms and adverse events. Synbiotic treatment in comparison to placebo significantly improved IBS-GIS (p = 0.043), and IBS-SSS score inducing a decrease in the total IBS-SSS (p = 0.042) and in domain-specific scores related to flatulence (p = 0.028) and bowel habit (p = 0.028) after four and eight weeks. Patients treated with synbiotics reported in weekly observations a significant amelioration in a feeling of incomplete bowel movements, flatulence, pain, stool pressure and diarrheal stools compared to those receiving placebo. There were no differences in adverse events between both groups. Concluding, the multi-strain synbiotic preparation was associated with a significant improvement in symptoms in IBS-D patients and was well-tolerated. These results suggest that the use of synbiotics offers a benefit for IBS-D patients. [Clinicaltrials.gov NCT04206410 registered 20 December 2019].

Background: In healthy adults, probiotic supplementation alone does not increase Urolithin A (UroA) and rarely increases butyrate, both microbiome-derived metabolites that influence key biological functions involved in regulating gastrointestinal symptoms. Accordingly, this clinical trial evaluated key biological functions of a multi-species synbiotic with 24 probiotic strains and a polyphenol-based prebiotic using capsule-in-capsule delivery technology. Methods: We conducted a randomized, placebo-controlled trial among healthy participants (n = 32). Participants were administered a daily synbiotic (53.6 billion AFU multi-species probiotic and 400 mg Indian pomegranate extract; DS-01) or matching placebo for 91 days. Samples were obtained at baseline Day 0, and Days 7, 14, 49, and 91. Endpoints included changes in fecal microbiome composition, urinary UroA, fecal butyrate, serum CRP, and safety. Results: The synbiotic significantly increased alpha-diversity of Bifidobacterium and Lactobacillus spp. at all timepoints, including at end-of-study (Day 91, p < 0.0001) and increased native beneficial microbes. UroA production was significantly increased in the synbiotic arm at short-term (Day 7, 12-fold, p < 0.02) and long-term (Day 91, 49-fold, p < 0.001) timepoints. A higher proportion of synbiotic participants were capable of converting polyphenols into UroA (Day 91, 100% vs. 44.4%; p < 0.01). Mechanistically, synbiotic participants showed an increased abundance of Lactobacillus species involved in UroA precursor metabolism and UroA-producing Gordonibacter species. The synbiotic also significantly increased fecal butyrate levels (p < 0.03), and butyrate-producing species, in low-baseline butyrate producers, through Day 91, and was associated with reduced systemic inflammation. Conclusions: This multi-species synbiotic significantly increases diversity and abundance of key beneficial bacteria, enhances UroA production and butyrate levels, and is associated with lowered systemic inflammation. This is the first synbiotic to increase both UroA and butyrate.

AimsProbiotics and/or prebiotics could be a promising approach to improve metabolic disorders by favorably modifying the gut microbial composition.ObjectivesTo assess the effects of probiotics and synbiotic on glycemic indices in prediabetic individuals who are at risk of type 2 diabetes and its complications.MethodsIn a double-blind, randomized, placebo-controlled parallel-group clinical trial, 120 prediabetic adults participated and were randomly allocated to receive either probiotics or synbiotic or placebo supplements for 24 weeks. Anthropometric measurements, food record, physical activity and glycemic biomarkers including glycated hemoglobin (HbA1C), fasting plasma glucose (FPG), fasting insulin levels (FIL), homoeostasis model assessment for insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), and β-cell function (HOMA-B) were assessed at baseline and repeated at 12 and 24 weeks and compared within and between three groups using repeated measure ANOVA.ResultsCompared with the placebo, synbiotic supplementation resulted in a higher significant reduction in FPG (− 6.5 ± 1.6 vs. − 0.82 ± 1.7 mg/dL, P = 0.01), FIL (− 2.6 ± 0.9 vs. − 0.8 ± 0.8 µIU/mL, P = 0.028), and HOMA-IR (− 0.86 ± 0.3 vs. − 0.16 ± 0.25, P = 0.007), and a significant elevation in the QUICKI (+ 0.01 ± 0.003 vs. + 0.003 ± 0.002, P = 0.006). In addition, significant decreases in HbA1C was seen following the supplementation of probiotics and synbiotic compared with the placebo (− 0.12 ± 0.06 and − 0.14 ± 0.05 vs. +0.07 ± 0.06%, P = 0.005 and 0.008, respectively). HOMA-B was not found to be different between or within the three groups.ConclusionGlycemic improvement by probiotics and particularly synbiotic supplements in prediabetic individuals has been supported by current study. However, further studies are required for optimal recommendations in this important area of patient treatment.Trial registrationIranian Registry of Clinical Trials: IRCT201511032321N2, Date registered February 27, 2016.

MicroRNAs (miRNAs) have emerged as important regulators of lipid metabolism. Recent studies have suggested synbiotics may modulate miRNA expression and lipid metabolism. This study aimed to investigate the effects of synbiotic supplementation on circulating miR-27a, miR-33a and lipid parameters in patients with dyslipidaemia. Fifty-six eligible participants were randomly allocated to receive either synbiotic or placebo sachets twice a day for 12 weeks. Each synbiotic sachet contained 3 × 1010 colony forming unit six species of probiotic microorganisms and 5 g of inulin and fructooligosaccharide as prebiotics. Serum miR-27a and miR-33a expression levels, serum lipids and apolipoproteins, the fecal concentration of short-chain fatty acids (SCFA) and Firmicutes and Bacteroidetes phyla were assessed before and after the study. Real-time PCR was used to determine the relative expression levels of miRNAs. The results showed synbiotic supplementation significantly downregulated the expression levels of miR-27a and miR-33a compared with the placebo group (P = 0·008 and P = 0·001, respectively). Furthermore, the intervention group exhibited significant improvements in serum HDL-cholesterol, small dense LDL (sdLDL-cholesterol), apoA-I and apoB-100 (P = 0·008, P = 0·006, P = 0·003, P = 0·001, respectively). The results showed a significant negative correlation between miR-33a expression levels with HDL-cholesterol, butyrate, propionate and a significant positive correlation with total cholesterol, LDL-cholesterol and sdLDL-cholesterol in the intervention group. Fecal bacteria and SCFA were significantly increased in the intervention group. This study provides evidence that synbiotic supplementation can modulate miR-27a and miR-33a expression and improve lipid metabolism in patients with dyslipidaemia.

Nonalcoholic fatty liver disease is the most prevalent chronic liver disease in Western countries; it can progress to nonalcoholic steatohepatitis (NASH), cirrhosis and hepatocarcinoma. The importance of gut-liver-adipose tissue axis has become evident and treatments targeting gut microbiota may improve inflammatory and metabolic parameters in NASH patients. In a randomized, controlled clinical trial, involving 50 biopsy-proven NASH patients, we investigated the effects of synbiotic supplementation on metabolic parameters, hepatic steatosis, intestinal permeability, small intestinal bacterial overgrowth (SIBO) and lipopolysaccharide (LPS) serum levels. Patients were separated into two groups receiving Lactobacillus reuteri with guar gum and inulin for three months and healthy balanced nutritional counseling versus nutritional counseling alone. Before and after the intervention we assessed steatosis by magnetic resonance imaging, intestinal permeability by lactulose/mannitol urinary excretion and SIBO by glucose breath testing. NASH patients presented high gut permeability, but low prevalence of SIBO. After the intervention, only the synbiotic group presented a reduction in steatosis, lost weight, diminished BMI and waist circumference measurement. Synbiotic did not improve intestinal permeability or LPS levels. We concluded that synbiotic supplementation associated with nutritional counseling seems superior to nutritional counseling alone for NASH treatment as it attenuates steatosis and may help to achieve weight loss.