Co-administration of probiotics and vitamin D reduced disease severity and complications in patients with Parkinson's disease: a randomized controlled clinical trial.

RATIONALE: Probiotics have beneficial effects on the nervous system by modulating the gut-brain axis. Additionally, vitamin D supplementation presents a potential way for ameliorating neuropsychological disorders, particularly in regions with a high prevalence of vitamin D deficiency. OBJECTIVES: The current clinical trial aimed to investigate the role of co-administered supplementation of probiotics and Vitamin D on the different inflammatory aspects of patients with Parkinson's disease. METHODS: Forty-six patients with PD were recruited From the Functional Neurosurgery Research Center, Tehran, Iran. These patients were randomly allocated to one of the two treatment groups: Group A, who received probiotic/vitamin D supplements (n = 23), and Group B who received placebo capsules (n = 23) for 12 weeks. As primary outcomes, Interferon-Gamma (IFN-γ), interleukin 1 beta (IL-1ß), IL-6, IL-10, Tumor Necrosis Factor-Alpha (TNF-α), total antioxidant capacity (TAC), and malondialdehyde (MDA) in serum were evaluated at the baseline and the end of the trial. Moreover, Additional questionnaire-based factors including gastrointestinal symptom rating scale (GSRS), Beck Anxiety Inventory (BAI), and Unified Parkinson's Disease Rating Scale (UPDRS) were evaluated. RESULTS: Our findings demonstrated that the consumption of probiotic/vitamin D supplements leads to a significant decrease in IL-1ß, INF-γ, IL-6, and MDA levels, while showing a significant increase in IL-10 and TAC levels compared to the placebo group (P < 0.05). Additionally, it leads to a significant decrease in the disease severity, anxiety, and gastrointestinal problems in PD patients in comparison to the placebo group (P < 0.05). CONCLUSIONS: Given the acknowledged role of inflammation in the pathogenesis of Parkinson's disease on one hand, and the recognized anti-inflammatory and antioxidant effects associated with probiotics and vitamin D on the other hand, the concurrent administration of probiotics and vitamin D supplements emerges as a promising and potentially effective treatment option for individuals with PD.

Anticancer Potential of Postbiotic Derived from Lactobacillus brevis and Lactobacillus casei: In vitro Analysis of Breast Cancer Cell Line.

Breast cancer has emerged as the most widespread and dangerous type of malignancy among women worldwide. Postbiotics have recently emerged as a promising novel adjunct in breast cancer therapy, due to their immunomodulatory effects and the potential to mitigate the adverse effects of conventional treatments. This study aims to investigate the therapeutic effects of postbiotics derived from Lactobacillus brevis (CSF2) and Lactobacillus casei (CFS5), specifically examining their ability to inhibit cell proliferation and induce apoptosis in MCF-7 breast cancer cells. In the current study, the anticancer activity of the cell-free supernatant of L. brevis and L. casei was investigated against MCF-7 cells using MTT assay, flow cytometry, and qRT-PCR technique. Both bacteria showed a high potential for the induction of cell death in MCF-7 cells. However, CFS2 cytotoxicity was significantly higher than CFS5. Flow cytometry results showed significant induction of early apoptosis in cells treated with both CFS2 and CFS5 within 48 h. The induction was notably higher in cells treated with CFS2 compared to CFS5. Overall, CFS2 therapy resulted in a greater increase in BAX and CASP9 gene expression, as well as an elevated BAX/BCL2 ratio within 48 h. These findings indicate that the CFS2 treatment showed a higher level of apoptotic activity than the CFS5 treatment. High biocompatibility was demonstrated following treatment with CFS2 and CFS5. These CFSs may serve as adjunctive medications for suppressing the proliferation of cancer cells. The results of the current study highlight the potential of postbiotics in cancer treatment and suggest that supernatants may serve as effective agents for suppressing cancer cell growth and viability.

Co-administration of probiotic and vitamin D significantly improves cognitive function in schizophrenic patients: A double-blinded randomized controlled trial.

AIM: Manipulation of the intestinal microbiome and supplying vitamin D can attenuate psychiatric symptoms in schizophrenic patients. The current study tried to evaluate the effects of probiotic/vitamin D supplementation on the cognitive function and disease severity of schizophrenic patients. METHODS: In the present study, 70 patients (aged 18-65) with schizophrenia were recruited. Participants were randomly allocated to the placebo (n = 35) and intervention (probiotic supplements+400 IU vitamin D, n = 35) groups. Severity of disease and cognitive function (primary outcomes) were evaluated by Positive and Negative Syndrome Scale (PANSS) and Montreal Cognitive Assessment (MoCA) tests, respectively. Moreover, lipid profile, body mass index (BMI), gastrointestinal (GI) problems, serum C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) were evaluated as secondary outcomes. RESULTS: A total of 69 patients completed the study. The MoCA score was increased by 1.96 units in the probiotic-containing supplement group compared to the placebo (p = 0.004). Also, the percentage of subjects with MoCA score ≥ 26 rose significantly in the intervention group (p = 0.031). Moreover, TC (p = 0.011), FBS (p = 0.009), and CRP (p < 0.001) significantly decreased in the supplement group compared to the placebo. Although the probiotic supplement reduced PANSS score by 2.82 units, the difference between the study groups was not statistically significant (p = 0.247). CONCLUSION: Co-administration of probiotics and vitamin D has beneficial effects on the improvement of cognitive function in schizophrenic patients.

Bacillus coagulans T4 and Lactobacillus paracasei TD3 Ameliorate Skeletal Muscle Oxidative Stress and Inflammation in High-Fat Diet-Fed C57BL/6J Mice.

Background: This study aims to investigate the effects of Bacillus coagulans T4 and Lactobacillus paracasei TD3 probiotics on skeletal muscle inflammation and oxidative stress in C57BL/6J mice fed a high-fat diet (HFD). Methods: Probiotics B. coagulans T4, and L. paracasei TD3 were administered to male C57BL/6J mice fed with HFD. The gene expression of macrophage infiltration markers, inflammatory cytokines, and oxidative stress indicators in the muscle tissue was investigated. Results: Treatment with B. coagulans T4 and L. paracasei TD3 reduced macrophage infiltration, accompanied by a decrease in the expression of monocyte chemoattractant protein-1 (MCP-1) and an increase in the expression of interleukin (IL)-10. On the other hand, L. paracasei TD3 decreased malondialdehyde (MDA) while B. coagulans T4 decreased carbonyl and increased catalase activity. Conclusions: Treatment with probiotics B. coagulans T4 and L. paracasei TD3 partially ameliorated obesity-induced skeletal muscle inflammation in HFD-fed mice.

Amelioration of obesity-induced white adipose tissue inflammation by Bacillus coagulans T4 in a high-fat diet-induced obese murine model.

AIM: Fresh evidence suggests that B. coagulans can be regarded as a promising therapeutic alternative for metabolic disorders. However, the possible effects of this probiotic on obesity-induced adipose tissue inflammation are unknown. METHODS: C57BL/6j male mice were assigned to a normal-chow diet (NCD) or a high-fat diet (HFD) for 10 weeks. After this period, HFD-fed mice were randomly divided into two groups; HFD control group and HFD plus B. coagulans T4 (IBRC-N10791) for another 8 weeks. B. coagulans T4 was administrated daily by oral intragastric gavage (1 × 109 colony-forming units). KEY FINDINGS: Here, we found that B. coagulans successfully mitigated obesity and related metabolic disorder, as indicated by reduced body weight gain, decreased adiposity, and improved glucose tolerance. B. coagulans T4 administration also inhibited HFD-induced macrophage accumulation in white adipose tissue and switched M1 to M2 macrophages. In parallel, B. coagulans T4 treatment attenuated HFD-induced alteration in mRNA expression of pro/anti-inflammatory cytokines and Tlr4 in white adipose tissue. Moreover, B. coagulans T4 supplementation reduced the Firmicutes/Bacteriodetes ratio and increased the number of Lactobacillus and Faecalibacterium compared to the HFD group. Additionally, a significant increase in propionate and acetate levels in the HFD group was seen following B. coagulans T4 administration. SIGNIFICANCE: Taken together, the present study provides evidence that B. coagulans T4 supplementation exerts anti-obesity effects in part through attenuating inflammation in adipose tissue. The present study will have significant implications for obesity management.

Effect of a Probiotic Supplement Containing Lactobacillus Acidophilus and Bifidobacterium Animalis Lactis on Urine Oxalate in Calcium Stone Formers with Hyperoxaluria: A Randomized, Placebo-controlled, Double-blind and In-vitro Trial.

PURPOSE: To determine the effect of a probiotic supplement containing native Lactobacillus acidophilus (L. acidophilus) and Bifidobacterium animalis lactis (B. lactis) on 24-hour urine oxalate in recurrent calcium stone formers with hyperoxaluria. Moreover, the in-vitro oxalate degradation capacity and the intestinal colonization of consumed probiotics were evaluated. MATERIALS AND METHODS: The oxalate degrading activity of L. acidophilus and B. lactis were evaluated in-vitro. The presence of oxalyl-CoA decarboxylase (oxc) gene in the probiotic species was assessed. One hundred patients were randomized to receive the probiotic supplement or placebo for four weeks. The 24-hour urine oxalate and the colonization of consumed probiotics were assessed after weeks four and eight. RESULTS: Although the oxc gene was present in both species, only L. acidophilus had a good oxalate degrading activity, in-vitro. Thirty-four patients from the probiotic and thirty patients from the placebo group finished the study. The urine oxalate changes were not significantly different between groups (57.21 ± 11.71 to 49.44 ± 18.14 mg/day for probiotic, and 56.43 ± 9.89 to 50.47 ± 18.04 mg/day for placebo) (P = .776). The probiotic consumption had no significant effect on urine oxalate, both in univariable (P = .771) and multivariable analyses (P = .490). The consumed probiotics were not detected in the stool samples of most participants. CONCLUSION: Our results showed that the consumption of a probiotic supplement containing L. acidophilus and B. lactis did not affect urine oxalate. The results may be due to a lack of bacterial colonization in the intestine.

Use of D-optimal combined design methodology to describe the effect of extraction parameters on the production of quinoa-barley malt extract by superheated water extraction.

Superheated water extraction was applied to produce quinoa-barley malt extract. D-optimal combined design was used to optimize the extraction conditions (time (min), solid-water ratio and particle size to obtain maximum protein and carbohydrate content, and minimum turbidity and pH. Quinoa flour (10%-30%), barley malt flour (70%-90%), different particle sizes (F = 420 µm, G = 710 µm), time (15-45 min), and solid-water ratio (0.1-0.2) were selected as independent variable and protein, carbohydrate, turbidity, and pH as dependent factors. Polynomials models satisfactorily fitted the experimental data with the R 2 values of .9961, .9909, .9949, and .9987, respectively. The protein and carbohydrate value was affected by superheated water extraction parameters. Our results revealed that increasing quinoa/barley malt ratio has significant effect on the turbidity and pH. The optimum extraction conditions were quinoa flour (30%), barley malt flour (70%), solid-water ratio (0.2), time (45 min), and particle size (F = 420 µm).

Analytic and chemometric assessments of the native probiotic bacteria and inulin effects on bioremediation of lead salts.

BACKGROUND: Lead (Pb2+ ) is one of the most toxic heavy metals and can be found in various quantities in the environment. The five native probiotic bacteria and inulin were used to assess in vitro lead nitrate and lead acetate binding capacities, as well as removal potentials. RESULTS: The highest decrease in media pH was seen for samples containing a combination of Lactobacillus paracasei IRBC-M 10784, lead nitrate and inulin (5.30 ± 0.012). The presence of inulin in the environment accelerated decreases in the pH of all samples with no significance. In all groups, lead nitrate-containing samples included maximum pH decreases. From the highest to the lowest, the ability of lead removal was linked to Lactobacillus acidophilus PTCC-1932 (88.48%), Bifidobacterium bifidum BIA-7 (85.32%), Bifidobacterium lactis BIA-6 (85.24%), Lactobacillus rhamnosus IBRC-M 10782 (83.18%) and L. paracasei IRBC-M 10784 (80.66%). Most species included the highest decrease in lead nitrate. Fourier-transform infrared spectroscopy (FTIR) analysis demonstrated that various functional groups (hydroxyl, carboxylic, carbonyl, amino and amide binds) on the bacterial cell wall were involved in lead ion binding during incubation. Principal component analysis of the FTIR results showed differences with respect to treated groups and control groups. CONCLUSION: The results obtained in the present study reveal that the simultaneous use of native probiotics and inulin can be an effective and safe approach for removing various toxic substances, especially Pb. © 2021 Society of Chemical Industry.

Effects of Lactobacillus casei Strain T2 (IBRC-M10783) on the Modulation of Th17/Treg and Evaluation of miR-155, miR-25, and IDO-1 Expression in a Cuprizone-Induced C57BL/6 Mouse Model of Demyelination.

Multiple sclerosis (MS) is a complex inflammatory disease in which demyelination occurs in the central nervous system affecting approximately 2.5 million people worldwide. Recent reports have shown that the gut microbiome plays a crucial role in the functioning of the immune system in inflammatory diseases such as MS. In this study, the cuprizone-induced demyelination mouse model was used to investigate the effect of Lactobacillus casei strain T2 (IBRC-M10783) on the alleviation of these mice. Female C57BL/6 mice (8-10 weeks old) were divided into 6 groups: group 1, normal control; group 2, cuprizone control (oral administration of cuprizone 0.2% w/w for 4 weeks); group 3, probiotic control (oral administration of 1 × 109 CFU/ml probiotic for 4 weeks); group 4, treatment 1 (probiotic for 4 weeks then cuprizone for 4 weeks); group 5, treatment 2 (cuprizone for 4 weeks then probiotic for 4 weeks); and group 6, treatment 3 (cuprizone for 4 weeks then probiotic for 4 weeks with vitamin D3 at a dose of 20 IU/day). Then, TGF-ß and IL-17 were measured by ELISA, and the expression of miR-155, miR-25, and IDO-1 was evaluated by real-time PCR. Among the measured microRNAs, the results showed that there was a significant decrease in miR-155 expression between the treatment 1 group and the cuprizone group. In the case of IL-17, the results also showed a significant reduction between the three treatment groups and the cuprizone group. These observations suggest that L. casei can reduce proinflammatory cytokines and reduce demyelinating symptoms in the mouse model.

Evaluation of lactic acid bacteria isolated from poultry feces as potential probiotic and its in vitro competitive activity against Salmonella typhimurium.

The efficacy of probiotics as alternatives to antibiotics has been defined as one of the potential strategies to prevent Salmonella spp. infection in poultry. The purpose of this study was to isolate probiotic native Lactic acid bacteria (LAB) with high compatibility to intestinal tract and prevention of Salmonella typhimurium from broiler chicken feces. Thirty-seven samples of chicken feces were collected from seven broiler chicken farms in Northern Iran. The isolates identification was carried out with morphological and biochemical tests. Agar diffusion methods were used to evaluate the antimicrobial activities against Escherichia coli and S. typhimurium. The primary probiotic characteristics such as resistance to acid and bile and adhesion to Caco-2 cells were studied. Indeed, the ability of LAB isolates to inhibit adhesion of S. typhimurium to Caco-2 cells was evaluated by exclusion, competition and displacement assays. Among 42 isolates, S08, S01 and S06 isolates which showed appropriate probiotics characteristics were selected. Isolates S08 and S01 showed to be able to adhere strongly and also S06 was adhered moderately. In the exclusion assay, the isolates S08, S01 and S06 significantly hampered adhesion of S. typhimurium cell, in the competition assay, the isolates S08, S01 showed significant level of competition activity against S. typhimurium adherence to Caco-2 cells and isolate S08 showed the greatest displacement activity. The 16S rDNA sequence revealed that S08, S01, and S06 isolates were 99.00% similar to Lactobacillus salivarius, Lactobacillus johnsonii, and Pediococcus acidilactici, respectively. The result of this study suggested that LAB isolated from broiler chicken feces could be a remarkable reservoir for identification of probiotic to inhibit the pathogenic bacteria growth.

Probiotic and selenium co-supplementation, and the effects on clinical, metabolic and genetic status in Alzheimer's disease: A randomized, double-blind, controlled trial.

BACKGROUND AND AIMS: Combined probiotic and selenium supplementation may improve Alzheimer's disease (AD) by correcting metabolic abnormalities, and attenuating inflammation and oxidative stress. This study aimed to determine the effects of probiotic and selenium co-supplementation on cognitive function and metabolic status among patients with AD. METHODS: This randomized, double-blind, controlled clinical trial was conducted among 79 patients with AD. Patients were randomly assigned to receive either selenium (200 µg/day) plus probiotic containing Lactobacillus acidophilus, Bifidobacterium bifidum, and Bifidobacterium longum (2 × 109 CFU/day each) (n = 27), selenium (200 µg/day) (n = 26) or placebo (n = 26) for 12 weeks. RESULTS: Selenium supplementation, compared with the placebo, significantly reduced serum high sensitivity C-reactive protein (hs-CRP) (P < 0.001), insulin (P = 0.001), homeostasis model of assessment-insulin resistance (HOMA-IR) (P = 0.002), LDL-cholesterol (P = 0.04) and total-/HDL-cholesterol ratio (P = 0.004), and significantly increased total glutathione (GSH) (P = 0.001) and the quantitative insulin sensitivity check index (QUICKI) (P = 0.01). Compared with only selenium and placebo, probiotic and selenium co-supplementation resulted in a significant increase in mini-mental state examination score (+1.5 ± 1.3 vs. +0.5 ± 1.2 and -0.2 ± 1.1, respectively, P < 0.001). Probiotic plus selenium intake resulted in a significant reduction in hs-CRP (-1.6 ± 1.4 vs. -0.8 ± 1.0 and +0.1 ± 0.5 mg/L, respectively, P < 0.001), and a significant increase in total antioxidant capacity (+89.4 ± 129.6 vs. +20.0 ± 62.5 and -0.7 ± 27.2 mmol/L, respectively, P = 0.001) and GSH (+122.8 ± 136.5 vs. +102.2 ± 135.2 and +1.5 ± 53.2 µmol/L, respectively, P = 0.001) compared with only selenium and placebo. In addition, subjects who received probiotic plus selenium supplements had significantly lower insulin levels (-2.1 ± 2.5 vs. -1.0 ± 1.3 and +0.7 ± 2.0 µIU/mL, respectively, P < 0.001), HOMA-IR (-0.5 ± 0.6 vs. -0.2 ± 0.3 and +0.1 ± 0.4, respectively, P < 0.001), and higher QUICKI (+0.01 ± 0.01 vs. +0.005 ± 0.007 and -0.002 ± 0.01, respectively, P < 0.006) compared with only selenium and placebo. Additionally, probiotic and selenium co-supplementation resulted in a significant reduction in serum triglycerides (-17.9 ± 26.1 vs. -3.5 ± 33.9 and +0.3 ± 9.3 mg/dL, respectively, P = 0.02), VLDL- (-3.6 ± 5.2 vs. -0.7 ± 6.8 and +0.05 ± 1.8 mg/dL, respectively, P = 0.02), LDL- (-8.8 ± 17.8 vs. -8.1 ± 19.2 and +2.7 ± 19.0 mg/dL, respectively, P = 0.04) and total-/HDL-cholesterol (-0.3 ± 0.7 vs. -0.4 ± 0.9 and +0.3 ± 0.6, respectively, P = 0.005) compared with only selenium and placebo. CONCLUSIONS: Overall, we found that probiotic and selenium co-supplementation for 12 weeks to patients with AD improved cognitive function and some metabolic profiles. This study was registered in the Iranian website (www.irct.ir) for registration of clinical trials (http://www.irct.ir: IRCT20170612034497N5).

The Effects of Synbiotic Supplementation on Carotid Intima-Media Thickness, Biomarkers of Inflammation, and Oxidative Stress in People with Overweight, Diabetes, and Coronary Heart Disease: a Randomized, Double-Blind, Placebo-Controlled Trial.

Synbiotics are known to exert multiple beneficial effects, including anti-inflammatory and antioxidant actions. The aim of this study was to evaluate the effects of synbiotic supplementation on carotid intima-media thickness (CIMT), biomarkers of inflammation, and oxidative stress in people with overweight, diabetes, and coronary heart disease (CHD). This randomized, double-blind, placebo-controlled trial was conducted and involved 60 people with overweight, diabetes, and CHD, aged 50-85 years old. Participants were randomly allocated into two groups to take either synbiotic supplements containing three probiotic bacteria spices Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 109 CFU/g each) plus 800 mg inulin or placebo (n = 30 each group) for 12 weeks. Fasting blood samples were taken at baseline and after the 12-week intervention period to determine metabolic variables. After the 12-week intervention, compared with the placebo, synbiotic supplementation significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 3101.7 ± 5109.1 vs. - 6.2 ± 3163.6 ng/mL, P = 0.02), plasma malondialdehyde (MDA) (- 0.6 ± 1.0 vs. - 0.1 ± 0.3 µmol/L, P = 0.01), and significantly increased nitric oxide (NO) levels (+ 7.8 ± 10.3 vs. - 3.6 ± 6.9 µmol/L, P < 0.001). We did not observe any significant changes of synbiotic supplementation on other biomarkers of oxidative stress and CIMT levels. Overall, synbiotic supplementation for 12 weeks among people with overweight, diabetes, and CHD had beneficial effects on serum hs-CRP, plasma NO, and MDA levels; however, it did not have any effect on other biomarkers of oxidative stress and CIMT levels.

The Effects of Synbiotic Supplementation on Metabolic Status in Women With Polycystic Ovary Syndrome: a Randomized Double-Blind Clinical Trial.

Data on the effects of synbiotic supplementation on glycemic control, lipid profiles, and atherogenic index of plasma (AIP) of women with polycystic ovary syndrome (PCOS) are limited. The purpose of this study was to assess the effects of synbiotic supplementation on glycemic control and lipid profiles in women with PCOS. A prospective, randomized, double-blind, placebo-controlled trial was done at the Naghavi Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran, between April 2017 and June 2017. Sixty women with PCOS were randomized to intake synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 109 CFU/g each) plus 800 mg inulin (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were taken at baseline and after the 12-week intervention to determine related variables. Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (- 2.8 ± 4.1 vs. + 1.8 ± 6.4 µIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (- 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. - 0.01 ± 0.03, P < 0.001). In addition, significant decreases in serum triglycerides (- 16.2 ± 31.4 vs. + 5.8 ± 23.1 mg/dL, P = 0.003), VLDL-cholesterol concentrations (- 3.3 ± 6.3 vs. + 1.1 ± 4.6 mg/dL, P = 0.003), and AIP (- 0.05 ± 0.08 vs. - 0.003 ± 0.10 mg/dL, P = 0.03) were seen following the supplementation of synbiotic compared with the placebo. Overall, we found that synbiotic supplementation to women with PCOS for 12 weeks had beneficial effects on markers of insulin resistance, triglycerides, VLDL-cholesterol concentrations, and AIP, but did not influence other lipid profiles. Trial registration: www.irct.ir: IRCT201604015623N71.

The Effects of Synbiotic Supplementation on Metabolic Status in Diabetic Patients Undergoing Hemodialysis: a Randomized, Double-Blinded, Placebo-Controlled Trial.

This study was conducted to evaluate the effects of synbiotic supplementation on metabolic profiles in diabetic patients undergoing hemodialysis (HD). This randomized, double-blinded, placebo-controlled clinical trial was performed in 60 diabetic HD patients. Participants were randomly assigned into two groups to receive either synbiotic capsule, containing Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum (2 × 109 CFU/g each), plus 0.8 g/day of inulin (n = 30) or placebo (n = 30) for 12 weeks. Synbiotic supplementation significantly decreased fasting plasma glucose (ß - 13.56 mg/dL; 95% CI, - 23.82, - 3.30; P = 0.01), insulin levels (ß - 5.49 µIU/mL; 95% CI, - 6.92, - 4.05; P < 0.001), and insulin resistance (ß - 2.25; 95% CI, - 3.02, - 1.48; P < 0.001), while increased the quantitative insulin sensitivity check index (ß 0.02; 95% CI, 0.01, 0.02; P < 0.001) compared with the placebo. Additionally, synbiotic intake resulted in a significant reduction in high-sensitivity C-reactive protein (ß - 2930.48 ng/mL; 95% CI, - 3741.15, - 2119.80; P < 0.001) and malondialdehyde levels (ß - 0.60 µmol/L; 95% CI, - 0.99, - 0.20; P = 0.003). Moreover, we found a significant increase in total antioxidant capacity (ß 142.99 mmol/L; 95% CI, 61.72, 224.25; P = 0.001) and total glutathione levels (ß 131.11 µmol/L; 95% CI, 89.35, 172.87; P < 0.001) in the synbiotic group compared with the placebo group. Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD. This study was registered in the Iranian website (www.irct.ir) for registration of clinical trials (http://www.irct.ir: IRCT2017090133941N17). http://www.irct.ir: IRCT2017090133941N17.

The effects of probiotic supplementation on metabolic status in type 2 diabetic patients with coronary heart disease.

BACKGROUND: This study was conducted to evaluate the effects of probiotic supplementation on metabolic profiles in diabetic patients with coronary heart disease (CHD). METHODS: This randomized, double-blind, placebo-controlled trial was performed among 60 diabetic patients with CHD, aged 40-85 years at a cardiology clinic in Kashan, Iran, from October 2017 through January 2018. Patients were randomly divided into two groups to take either probiotic supplements (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were taken at the beginning of the study and after the 12-week intervention to determine related markers. RESULTS: After 12-week intervention, probiotic supplementation significantly decreased fasting plasma glucose (ß - 20.02 mg/dL; 95% CI - 33.86, - 6.17; P = 0.005), insulin (ß - 2.09 µIU/mL; 95% CI - 3.77, - 0.41; P = 0.01), insulin resistance (ß - 0.50; 95% CI - 0.96, - 0.03; P = 0.03) and total-/HDL-cholesterol ratio (ß - 0.27; 95% CI - 0.52, - 0.03; P = 0.02), and significantly increased insulin sensitivity (ß 0.008; 95% CI 0.001, 0.01; P = 0.02) and HDL-cholesterol levels (ß 2.52 mg/dL; 95% CI 0.04, 5.00; P = 0.04) compared with the placebo. Moreover, probiotic supplementation led to a significant reduction in serum high sensitivity C-reactive protein (ß - 0.88 mg/L; 95% CI - 1.39, - 0.38; P = 0.001), and a significant elevation in total antioxidant capacity (ß 108.44 mmol/L; 95% CI 47.61, 169.27; P = 0.001) and total glutathione levels (ß 45.15 µmol/L; 95% CI 5.82, 84.47; P = 0.02) compared with the placebo. Probiotic supplementation did not affect other metabolic profiles. CONCLUSIONS: Overall, we found that probiotic supplementation for 12 weeks had beneficial effects on glycemic control, HDL-cholesterol, total-/HDL-cholesterol ratio, biomarkers of inflammation and oxidative stress in diabetic patients with CHD.Trial registration Clinical trial registration number http://www.irct.ir: IRCT2017082733941N5.

The effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: To our knowledge, no reports are available indicating the effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome (PCOS). This research was done to assess the effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with PCOS. METHODS: This randomized double-blind, placebo-controlled trial was conducted on 60 subjects diagnosed with PCOS according to the Rotterdam criteria. Subjects were randomly assigned into two groups to take either synbiotic (n = 30) or placebo (n = 30) for 12 weeks. Endocrine, inflammation and oxidative stress biomarkers were quantified at baseline and after the 12-week intervention. RESULTS: After the 12-week intervention, compared with the placebo, synbiotic supplementation significantly increased serum sex hormone-binding globulin (SHBG) (changes from baseline in synbiotic group: + 19.8 ± 47.3 vs. in placebo group: + 0.5 ± 5.4 nmol/L, p = 0.01), plasma nitric oxide (NO) (changes from baseline in synbiotic group: + 5.5 ± 4.8 vs. in placebo group: + 0.3 ± 9.1 µmol/L, p = 0.006), and decreased modified Ferriman Gallwey (mF-G) scores (changes from baseline in synbiotic group: - 1.3 ± 2.5 vs. in placebo group: - 0.1 ± 0.5, p = 0.01) and serum high-sensitivity C-reactive protein (hs-CRP) (changes from baseline in synbiotic group: - 950.0 ± 2246.6 vs. in placebo group: + 335.3 ± 2466.9 ng/mL, p = 0.02). We did not observe any significant effect of synbiotic supplementation on other hormonal status and biomarkers of oxidative stress. CONCLUSIONS: Overall, synbiotic supplementation for 12 weeks in PCOS women had beneficial effects on SHBG, mFG scores, hs-CRP and NO levels, but did not affect other hormonal status and biomarkers of oxidative stress. TRIAL REGISTRATION: This study was retrospectively registered in the Iranian website ( www.irct.ir ) for registration of clinical trials ( IRCT201509115623N53 ), on 2015-09-27.

Effects of Probiotic Supplementation on Hormonal Profiles, Biomarkers of Inflammation and Oxidative Stress in Women With Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: To the best of our knowledge, data on effects of probiotic administration on hormonal profiles, biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome (PCOS) are scarce. This investigation was conducted to assess the effects of probiotic supplementation on hormonal profiles, biomarkers of inflammation and oxidative stress in women with PCOS. METHODS: This randomized, double-blind, placebo-controlled trial was conducted on 60 women with PCOS, aged 18-40 years old. Subjects were randomly assigned into 2 groups to receive either probiotics or placebo (n = 30 each group) for 12 weeks. Metabolic profiles were quantified at baseline and after a 12-week intervention. RESULTS: After the 12-week intervention, compared with placebo, probiotic supplementation significantly increased serum sex hormone-binding globulin (SHBG) (+25.9 ± 32.5 vs. +0.5 ± 15.6 nmol/L, P < 0.001) and plasma total antioxidant capacity (TAC) (+8.8 ± 120.5 vs. -98.3 ± 246.4 mmol/L, P = 0.04), and significantly decreased serum total testosterone (-0.2 ± 0.7 vs. +0.2 ± 0.6 ng/mL, P = 0.03), modified Ferriman-Gallwey (mF-G) scores (-1.7 ± 1.5 vs. -0.2 ± 1.0, P < 0.001), serum high-sensitivity C-reactive protein (hs-CRP) (-1150.0 ± 1295.2 vs. +202.5 ± 1426.3 ng/mL, P < 0.001) and plasma malondialdehyde (MDA) concentrations (-0.2 ± 0.6 vs. +0.9 ± 1.3 µmol/L, P < 0.001). We did not observe any detrimental effect of probiotic supplementation on other metabolic profiles. CONCLUSION: Overall, probiotic supplementation of PCOS women for 12 weeks had beneficial effects on total testosterone, SHBG, mFG scores, hs-CRP, TAC and MDA levels but did not affect other metabolic profiles.

The effects of probiotic supplementation on biomarkers of inflammation, oxidative stress and pregnancy outcomes in gestational diabetes.

OBJECTIVE: This study was designed to evaluate the effects of probiotic supplementation on biomarkers of inflammation, oxidative stress and pregnancy outcomes among subjects with gestational diabetes (GDM). METHODS: This randomized, double-blind, placebo-controlled clinical trial was done among 60 subjects with GDM who were not on oral hypoglycemic agents. Patients were randomly allocated to intake either probiotic capsule containing Lactobacillus acidophilus, Lactobacillus casei and Bifidobacterium bifidum (2 × 109 CFU/g each) (n = 30) or placebo (n = 30) for six weeks. RESULTS: Compared with the placebo, probiotic supplementation resulted in significant decreases in fasting plasma glucose (FPG) (-5.3 ± 6.7 vs. +0.03 ± 9.0 mg/dL, p = .01), serum high-sensitivity C-reactive protein (hs-CRP) (-2.2 ± 2.7 vs. +0.5 ± 2.4 µg/mL, p < .001), plasma malondialdehyde (MDA) concentrations (-0.1 ± 0.8 vs. +0.5 ± 1.5 µmol/L, p = .03) and MDA/TAC ratio (-0.0003 ± 0.0008 vs. +0.0009 ± 0.002, p = .004), and a significant increase in total antioxidant capacity (TAC) levels (+65.4 ± 103.3 vs. -37.2 ± 143.7 mmol/L, p = .002). Probiotic supplementation did not affect pregnancy outcomes. CONCLUSIONS: Overall, probiotic supplementation among women with GDM for six weeks had beneficial effects on FPG, serum hs-CRP, plasma TAC, MDA and oxidative stress index, but did not affect pregnancy outcomes.

The beneficial effects of probiotic administration on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial.

BACKGROUND: This study was conducted to evaluate the effects of probiotic supplementation on wound healing and metabolic status in subjects with diabetic foot ulcer (DFU). METHODS: This randomized, double-blind, placebo-controlled trial was conducted among 60 subjects (aged 40-85 years old) with grade 3 diabetic foot ulcer. Individuals were randomly divided into 2 groups (30 subjects each group) to receive either probiotic or placebo daily for 12 weeks. RESULTS: After the 12-week intervention, compared with the placebo, probiotic supplementation led to significant reductions in ulcer length (-1.3 ± 0.9 vs. -0.8 ± 0.7 cm, P = .01), width (-1.1 ± 0.7 vs. -0.7 ± 0.7 cm, P = .02), and depth (-0.5 ± 0.3 vs. -0.3 ± 0.3 cm, P = .02). Furthermore, significant reductions in fasting plasma glucose (-29.6 ± 30.3 vs. -5.8 ± 39.8 mg/dL, P = .01), serum insulin concentrations (-4.3 ± 7.9 vs. +0.4 ± 8.5 µIU/mL, P = .03), and haemoglobin A1c (-0.6 ± 0.5 vs. -0.2 ± 0.4%, P = .003) and a significant rise in the quantitative insulin sensitivity check index (+0.01 ± 0.01 vs. -0.01 ± 0.02, P = .003) were seen following supplementation of probiotic compared with the placebo. Additionally, compared with the placebo, probiotic supplementation resulted in significant decreases in serum total cholesterol (-4.8 ± 16.1 vs. +7.0 ± 27.1 mg/dL, P = .04), high-sensitivity C-reactive protein (-9.0 ± 14.7 vs. -1.7 ± 8.6 mg/L, P = .02), plasma malondialdehyde (-0.8 ± 0.8 vs. -0.2 ± 0.8 µmol/L, P = .001), and significant increases in plasma nitric oxide (+6.2 ± 8.2 vs. +0.8 ± 8.0 µmol/L, P = .01) and total antioxidant capacity concentrations (+179.3 ± 97.2 vs. -85.1 ± 203.4 mmol/L, P < .001). CONCLUSIONS: Overall, probiotic supplementation for 12 weeks among subjects with diabetic foot ulcer had beneficial effects on ulcer size, glycaemic control, total cholesterol, high-sensitivity C-reactive protein, plasma nitric oxide, total antioxidant capacity, and malondialdehyde levels.