Impact of Probiotic SYNBIO(®) Administered by Vaginal Suppositories in Promoting Vaginal Health of Apparently Healthy Women.

The purpose of this study was to investigate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether it promotes normalization and maintenance of pH and Nugent score. A single-arm, open-label controlled towards the baseline (pre-post) study including 35 apparently healthy women was conducted. Each woman was examined three times during the study. Women were instructed to receive daily for 7 days, the probiotic suppositories SYNBIO(®) gin (Lactobacillus rhamnosus IMC 501(®) and Lactobacillus paracasei IMC 502(®)). Vaginal swabs were collected during visit 1, 2, and 3 to determine the total lactobacilli count, the presence of the two administered bacteria, the measure of the pH, and the estimation of Nugent score. Evaluation of treatment tolerability was based on analysis of the type and occurrence of adverse events. The probiotic vaginal suppository was well tolerated and no side effects were reported. Intermediate Nugent score was registered in 40 % of women at visit 1 and these intermediate scores reverted to normal at day 7 (end of treatment) in 20 % of subjects. Administration of SYNBIO(®) gin contributed to a significant increase in the lactobacilli level at visit 2. Molecular typing revealed the presence of the two strains originating from SYNBIO(®) gin in 100 % of women at visit 2 and 34 % at visit 3. No significant changes were registered for pH between visits. The SYNBIO(®) gin product is safe for daily use in healthy women and it could be useful to restore and maintain a normal vaginal microbiota.

Probiotic-enriched foods and dietary supplement containing SYNBIO positively affects bowel habits in healthy adults: an assessment using standard statistical analysis and Support Vector Machines.

A randomised, double-blind, placebo-controlled, parallel group study assessed in healthy adults how daily consumption of the probiotic combination SYNBIO®, administered in probiotic-enriched foods or in a dietary supplement, affected bowel habits. Primary and secondary outcomes gave the overall assessment of bowel well-being, while a Psychological General Well-Being Index compiled by participants estimated the health-related quality of life as well as the gastrointestinal tolerance determined with the Gastrointestinal Symptom Rating Scale. Support Vector Machine models for classification problems were used to validate the total outcomes on bowel well-being. SYNBIO® consumption improved bowel habits of volunteers consuming the probiotic foods or capsules, while the same effects were not registered in the control groups. The recovery of probiotic bacteria from the faeces of a cohort of 100 subjects for each supplemented group showed the persistence of strains in the gastrointestinal tract.

Effect of buckwheat flour and oat bran on growth and cell viability of the probiotic strains Lactobacillus rhamnosus IMC 501®, Lactobacillus paracasei IMC 502® and their combination SYNBIO®, in synbiotic fermented milk.

Fermented foods have a great significance since they provide and preserve large quantities of nutritious foods in a wide diversity of flavors, aromas and texture, which enrich the human diet. Originally fermented milks were developed as a means of preserving nutrients and are the most representatives of the category. The first aim of this study was to screen the effect of buckwheat flour and oat bran as prebiotics on the production of probiotic fiber-enriched fermented milks, by investigating the kinetics of acidification of buckwheat flour- and oat bran-supplemented milk fermented by Lactobacillus rhamnosus IMC 501®, Lactobacillus paracasei IMC 502® and their 1:1 combination named SYNBIO®. The probiotic strains viability, pH and sensory characteristics of the fermented fiber-enriched milk products, stored at 4 °C for 28 days were also monitored. The results showed that supplementation of whole milk with the tested probiotic strains and the two vegetable substrates results in a significant faster lowering of the pH. Also, the stability of L. rhamnosus IMC 501®, L. paracasei IMC 502® and SYNBIO® during storage at 4 °C for 28 days in buckwheat flour- and oat bran-supplemented samples was remarkably enhanced. The second aim of the study was to develop a new synbiotic product using the best combination of probiotics and prebiotics by promoting better growth and survival and be acceptable to the consumers with high concentration of probiotic strain. This new product was used to conduct a human feeding trial to validate the fermented milk as a carrier for transporting bacterial cells into the human gastrointestinal tract. The probiotic strains were recovered from fecal samples in 40 out of 40 volunteers fed for 4 weeks one portion per day of synbiotic fermented milk carrying about 10(9) viable cells.

Functional foods as carriers for SYNBIO®, a probiotic bacteria combination.

The popularity of functional foods continues to increase as consumers desire flavorful foods that will fulfil their health needs. Among these foods, probiotics may exert positive effects on the composition of gut microbiota and overall health. However, in order to be beneficial, the bacterial cultures have to remain live and active at the time of consumption. The aim of this study was to develop new probiotic food products, such as seasoned cheeses, salami, chocolate and ice-cream with a final probiotic concentration of approximately 109CFU/daily dose of Lactobacillus rhamnosus IMC 501® and Lactobacillus paracasei IMC 502® mixed 1:1 (SYNBIO®). The survival and viability of probiotics were determined during the foods shelf-life. The values of viable probiotic bacteria of all dairy and non-dairy foods were between 107 and 109CFU/g of food at the end of the shelf-life and for some of them the values were maintained even after the expiry date. Based on the results of the current study, all the dairy ("Caciotta" cheese, "Pecorino" cheese, "Büscion" Swiss cheese and "Fiordilatte" ice-cream) and non-dairy ("Ciauscolo" salami, Larded salami, Swiss small salami, milk chocolate, dark chocolate, organic jam and chocolate mousse) food products studied would be excellent vehicles to deliver the probiotic health effects because of the high viability of probiotics during the shelf-life of foods and in some cases even after their expiry date.

Pilot-scale production and viability analysis of freeze-dried probiotic bacteria using different protective agents.

The functional food industry requires an improvement of probiotic strain stability during storage, especially when they are stored at room temperature. In this study, the viability of freeze-dried Lactobacillus rhamnosus IMC 501(®) and Lactobacillus paracasei IMC 502(®) using different protective agents (i.e., glycerine, mannitol, sorbitol, inulin, dextrin, Crystalean(®)) was determined and compared with semi skimmed milk (SSM) control. No significant differences were observed between the tested protectants and the control (SSM) during storage at refrigerated conditions. During storage at room temperature, only glycerine was found to stabilize viability better than other tested substances.

Probiotic properties of Lactobacillus rhamnosus and Lactobacillus paracasei isolated from human faeces.

BACKGROUND: The possibility of using microbes to maintain health, and to prevent or treat disease is a topic as old as microbiology. The research of novel probiotic strains is important in order to satisfy the increasing request of the market and to obtain functional products in which the probiotic cultures are more active and with better probiotic characteristics than those already present on the market. AIM OF THE STUDY: In this study, the probiotic potential of Lactobacillus strains isolated from Italian elderly human faeces was investigated. METHODS: The Lactobacillus strains were identified and examined for resistance to gastric acidity and bile toxicity, adhesion to HT-29 cells, antimicrobial activities, antibiotic susceptibility and plasmid profile. Survival of the strains through human intestine was examined in a 3 months human feeding trial. RESULTS: Two strains, Lactobacillus rhamnosus IMC 501 and Lactobacillus paracasei IMC 502, tolerated well low pH and bile acids. In antimicrobial activity assays, both strains showed inhibitory properties towards selected potential harmful microorganisms, particularly against Candida albicans. The two selected strains expressed high in vitro adherence to HT-29 cells increasing this characteristic when they are used in combination and they were resistant to vamcomycin, colistin sulphate, gentamicin, oxolinic acid and kanamycin. Moreover, the two strains could be recovered from stools of volunteers after the feeding trials. CONCLUSIONS: Lactobacillus rhamnosus IMC 501 and L. paracasei IMC 502 present favourable strain-specific properties for their utilisation as probiotics in functional foods and the high adhesion ability of the L. rhamnosus IMC 501 and L. paracasei IMC 502 used in combination, confirmed by both in vitro and in vivo study, indicate that the two bacterial strains could be used as health-promoting bacteria.

Differences in fecal microbiota in different European study populations in relation to age, gender, and country: a cross-sectional study.

A cross-sectional study on intestinal microbiota composition was performed on 230 healthy subjects at four European locations in France, Germany, Italy, and Sweden. The study participants were assigned to two age groups: 20 to 50 years (mean age, 35 years; n = 85) and >60 years (mean age, 75 years; n = 145). A set of 14 group- and species-specific 16S rRNA-targeted oligonucleotide probes was applied to the analysis of fecal samples by fluorescence in situ hybridization coupled with flow cytometry. Marked country-age interactions were observed for the German and Italian study groups. These interactions were inverse for the predominant bacterial groups Eubacterium rectale-Clostridium coccoides and Bacteroides-Prevotella. Differences between European populations were observed for the Bifidobacterium group only. Proportions of bifidobacteria were two- to threefold higher in the Italian study population than in any other study group, and this effect was independent of age. Higher proportions of enterobacteria were found in all elderly volunteers independent of the location. Gender effects were observed for the Bacteroides-Prevotella group, with higher levels in males than in females. In summary, age-related differences in the microbiota makeup were detected but differed between the study populations from the four countries, each showing a characteristic colonization pattern.

Red wine polyphenols influence carcinogenesis, intestinal microflora, oxidative damage and gene expression profiles of colonic mucosa in F344 rats.

Polyphenols from tea and other beverages such as red wine have been regarded with interest as possible chemopreventive agents against cancer. Here we report that red wine polyphenols (50 mg/kg) administered with the diet to F344 rats for 16 weeks inhibited colon carcinogenesis induced by azoxymethane (AOM, 7.4 mg/kg, total dose 74 mg/kg) or dimethylhydrazine (DMH, 30 mg/kg, total dose, 300 mg/kg). Polyphenol-treated animals had a consistently lower tumour yield compared to controls. In polyphenol-treated rats, the main bacterial strains in the faeces at sacrifice were Bacteroides, Lactobacillus and Bifidobacterium spp., whereas microorganisms predominantly identified in control-fed rats were Bacteroides, Clostridium and Propionibacterium spp. Wine polyphenols (57 mg/kg for 10 days, by gavage), administered to rats not treated with carcinogens, produced a significant decrease in the basal level of DNA oxidative damage of the colon mucosa as measured with the comet assay (average pyrimidine oxidation was reduced by 62% and purine oxidation by 57%, p<0.05). To further explore the molecular effects of wine polyphenols we used the microarray technology to study gene expression profiles: rats were treated with 50 mg/kg wine polyphenols for 14 days, mixed in the diet. Global expression analysis of 5707 genes revealed an extensive down-regulation of genes involved in a wide range of physiological functions, such as metabolism, transport, signal transduction and intercellular signalling. By analysing metabolic pathways with the GenMAPP software program we observed that two major regulatory pathways were down-regulated in the colon mucosa of polyphenols-treated rats: inflammatory response and steroid metabolism. We also found a down-regulation of many genes regulating cell surface antigens, metabolic enzymes and cellular response to oxidative stress. In conclusion, reduction of oxidative damage, modulation of colonic flora and variation in gene expression may all concur in the modulation of intestinal function and carcinogenesis by wine polyphenols.

Effects of different digestible carbohydrates on bile acid metabolism and SCFA production by human gut micro-flora grown in an in vitro semi-continuous culture.

The main source of carbon in the human large intestine comes from carbohydrates like starches and oligosaccharides which remain unchanged by gastric digestion. These polysaccharides are metabolised in the colon by saccharolytic bacteria whose composition is dependent upon the substrate availability. Among the metabolites produced, the short-chain fatty acids (SCFA) are important for colon function and to prevent diseases. In particular, butyrate affects several cellular functions (proliferation, membrane synthesis, sodium absorption), and it has been shown to be protective against colorectal cancer. In addition, faecal bacteria are responsible for the conversion of primary bile acids (BA) to secondary BA, which are considered tumor promoters. In this study we investigated the in vitro effect of different substrates (CrystaLean starch, xylo-oligosaccharides, corn starch) supplied to human faecal micro-flora, on the SCFA production, on the bowel micro-flora composition and on the primary BA conversion rate. In addition, with corn starch as substrate, we considered the effect of enriching normal human faecal micro-flora with lactobacilli and bifidobacteria, on the above reported parameters.

Fecal levels of short-chain fatty acids and bile acids as determinants of colonic mucosal cell proliferation in humans.

We studied the correlation between fecal levels of short-chain fatty acids (SCFA), bile acids (BA), and colonic mucosal proliferation in humans on a free diet. Subjects [n = 43: 27 men and 16 women; 61 +/- 7 and 59 +/- 6 (SE) yr old, respectively] were outpatients who previously underwent resection of at least two sporadic colon polyps. Mucosal proliferation was determined by [3H]thymidine incorporation in vitro in three colorectal biopsies obtained without cathartics and was expressed as labeling index (LI). BA were analyzed in feces by mass spectrometry and SCFA by gas chromatography. We found that increasing levels of BA in feces did not correlate with higher LI. On the contrary, higher levels of SCFA were significantly associated with lower LI in the colonic mucosa (P for trend = 0.02). In conclusion, in humans on a free diet, intestinal proliferation seems to be regulated by the levels of SCFA in feces and not by BA. Because a lower intestinal proliferation is associated with a decreased colon cancer risk, treatments or diets that increase colonic levels of SCFA might be beneficial for colonic mucosa.