Randomised controlled trial of the effect of long-term selenium supplementation on plasma cholesterol in an elderly Danish population.

Although cross-sectional studies have shown a positive association between Se and cholesterol concentrations, a recent randomised controlled trial in 501 elderly UK individuals of relatively low-Se status found that Se supplementation for 6 months lowered total plasma cholesterol. The Danish PRECISE (PREvention of Cancer by Intervention with Selenium) pilot study (ClinicalTrials.gov ID: NCT01819649) was a 5-year randomised, double-blinded, placebo-controlled trial with four groups (allocation ratio 1:1:1:1). Men and women aged 60-74 years (n 491) were randomised to 100 (n 124), 200 (n 122) or 300 (n 119) µg Se-enriched yeast or matching placebo-yeast tablets (n 126) daily for 5 years. A total of 468 participants continued the study for 6 months and 361 participants, equally distributed across treatment groups, continued for 5 years. Plasma samples were analysed for total and HDL-cholesterol and for total Se concentrations at baseline, 6 months and 5 years. The effect of different doses of Se supplementation on plasma lipid and Se concentrations was estimated by using linear mixed models. Plasma Se concentration increased significantly and dose-dependently in the intervention groups after 6 months and 5 years. Total cholesterol decreased significantly both in the intervention groups and in the placebo group after 6 months and 5 years, with small and nonsignificant differences in changes in plasma concentration of total cholesterol, HDL-cholesterol, non-HDL-cholesterol and total:HDL-cholesterol ratio between intervention and placebo groups. The effect of long-term supplementation with Se on plasma cholesterol concentrations or its sub-fractions did not differ significantly from placebo in this elderly population.

Selenium supplementation for patients with Graves' hyperthyroidism (the GRASS trial): study protocol for a randomized controlled trial.

BACKGROUND: Graves' hyperthyroidism is an autoimmune disease causing hyperfunction of the thyroid gland. The concentration of selenium is high in the thyroid gland and two important groups of enzymes within the thyroid are selenoproteins, that is, they depend on selenium. Selenium may have beneficial effects on autoimmune hypothyroidism and on Graves' orbitopathy, but the effects of selenium on Graves' hyperthyroidism is unknown.We hypothesize that adjuvant selenium may be beneficial in the treatment of Graves' hyperthyroidism. The objective is to investigate if selenium supplementation plus standard treatment with anti-thyroid drugs versus standard treatment with anti-thyroid drugs will lead to a decrease in anti-thyroid drug treatment failure (that is, failure to remain euthyroid, without further treatment, one year after cessation of anti-thyroid drug treatment), faster and longer lasting remission (that is, anti-thyroid drug treatment success), and improved quality of life in patients with Graves' hyperthyroidism. METHODS AND DESIGN: The trial is an investigator-initiated, randomised, blinded, multicentre clinical trial. Inclusion criteria are: age 18 years or older; diagnosis of active Graves' hyperthyroidism within the last two months; and informed consent. Exclusion criteria are major co-morbidity; previous radioactive iodine treatment; ongoing anti-thyroid drug treatment for more than two months; treatment with immunomodulatory drugs; known allergy towards the components in the selenium and placebo pills; pregnancy or breast-feeding; and intake of selenium supplementation above 70 µg per day. We plan to include 492 participants, randomised (1:1) to two tablets of 100 µg selenium once daily for the 24 to 30 months intervention period versus two identical placebo tablets once daily.The primary outcome is the proportion of participants with anti-thyroid drug treatment failure (see above) at the end of the intervention period (24 to 30 months). Secondary outcomes are: thyroid-specific quality of life during the first year after randomisation; level of thyroid stimulating hormone-receptor antibodies at 18 months after randomisation and at the end of the intervention period (24 to 30 months); hyperthyroid symptoms during the first year after randomisation; eye symptoms during the first year after randomisation, and at the end of the intervention period (24 to 30 months); adverse reactions during the intervention period; and serious adverse events during the intervention period. DISCUSSION: It was of great importance to the initiators of this trial, that the results would be directly applicable to daily clinical practice. Therefore, it was designed as a pragmatic trial: the patients follow their usual treatment at their usual hospitals. In order to still collect high quality data on the clinical course and quality of life, an elaborate trial management system was designed to keep track of patient input, need for trial personnel input and action, and to collect data from medical chart systems. Meticulous follow-up on missing responses to the QoL measurements has been incorporated into the system, to minimise missing quality of life data. Monitoring of adverse reactions and events is achieved by thorough instruction of the participants, surveillance of patient-reported outcomes, and integration with national databases regarding hospitalizations. A very long intervention period was necessary, since patients are not considered in remission until one year after stopping anti-thyroid drugs. Usually, patients are treated for 12 to 18 months with anti-thyroid drugs, yielding a total intervention period of 24 to 30 months. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01611896.

Effects of albusin B (a bacteriocin) of Ruminococcus albus 7 expressed by yeast on growth performance and intestinal absorption of broiler chickens--its potential role as an alternative to feed antibiotics.

BACKGROUND: Bacteriocins with antimicrobial activity are considered as potential alternatives to antibiotics. The aim of this study was to investigate the effect of albusin B (bacteriocin) of Ruminococcus albus 7 expressed by yeast on the growth performance of broiler chickens. Ninety 1-day-old healthy broiler chickens were randomly divided into three groups: control, albusin B (2.5 g kg(-1)) and nosiheptide (2.5 mg kg(-1), antibiotic control). Growth performance and intestinal functions were measured at 5 weeks of age. RESULTS: Albusin B-supplemented broilers showed increased body weight gain compared with control broilers (54.7 ± 5.3 vs 48.5 ± 6.1 g day(-1) per bird, P < 0.05). Broilers supplemented with nosiheptide had a less developed mucosal layer than broilers in the other two groups. Compared with the control group, broilers supplemented with albusin B or nosiheptide showed increased mRNA expression of sGLT1, GLUT2 and PEPT1 in the jejunum (P < 0.05). The faecal Lactobacillus count was higher in the albusin B group than in the other two groups (P < 0.05). CONCLUSION: Albusin B supplementation increased intestinal absorption and elevated the faecal Lactobacillus count, thereby promoting the growth performance of broiler chickens. These improvements resulting from albusin B supplementation provide evidence of potential alternatives to antibiotics in broiler chicken feed.

Immunogenic yeast-based fermentate for cold/flu-like symptoms in nonvaccinated individuals.

BACKGROUND: The common cold has a profound impact on employee attendance and productivity. Seasonal influenza is responsible for approximately 200,000 hospitalizations and 36,000 deaths per year in the United States alone. Over-the-counter medication efficacy has been questioned, and seasonal vaccination compliance issues abound. Our previously reported randomized trial of an oral fermentation product found an adjuvant benefit for vaccinated individuals in terms of a significantly reduced incidence and duration of cold and flu-like symptoms. METHODS: A concurrent 12-week, randomized, double-blind, placebo-controlled clinical trial of 116 subjects with no recent history of seasonal influenza vaccination was conducted. Participants received once-daily supplementation with 500 mg of a dried modified Saccharomyces cerevisiae oral fermentate (EpiCor) or placebo. Clinical outcome measurements included periodic interval-based in-clinic examinations and serologic analysis at baseline, 6 weeks, and 12 weeks. Participants utilized a standardized self-report symptom diary. RESULTS: Subjects receiving the intervention experienced a statistically significant reduction in the incidence (p = 0.01), a nonsignificant reduction in duration (p = 0.10), and no impact on the severity (p = 0.90) of colds or flu-like symptoms, but a more favorable safety profile compared with subjects receiving placebo. CONCLUSIONS: This nutritional-based fermentate appeared to be safe and efficacious in a unique at-risk population and should receive more clinical research as a potential method to reduce the incidence of cold and flu-like symptoms, in individuals with and without a history of influenza vaccination.

Effects of dietary dried baker's yeast on the performance, egg traits and blood parameters in laying quails.

This study was conducted to investigate the effects of dietary dried baker's yeast on laying performance, egg traits and some blood parameters of quails. In the experiment a total of 342 Japanese quails (Coturnix coturnix japonica) aged ten weeks were equally divided into six groups of 57 (three replicates of 19 quails each). Six levels (0, 4, 8, 12, 16 and 20%) of dried baker's yeast were included in isonitrogenous and isocaloric diets. The experimental period lasted 14 weeks. At the end of the experiment, there were no significant differences among the groups in body weight, feed intake, protein intake, egg production, feed efficiency, egg yolk index and egg haugh unit. Blood serum levels of total protein, triglyceride and cholesterol were not affected by dietary dried baker's yeast. Diets containing 4 and 8% of dried baker's yeast increased the egg weight significantly (p < 0.01). The inclusion of dried baker's yeast at the level of 20% to the diets reduced egg shell thickness and egg albumen height. It is concluded that dried baker's yeast can be used up to 16% in the diets of laying quails without adverse effects on the measured parameters.

Invasive infections due to Saccharomyces boulardii (Ultra-levure).

(1) Saccharomyces boulardii, a yeast closely related to Saccharomyces cerevisiae, is marketed in France for adjuvant treatment of diarrhoea, although it has no proven efficacy. (2) Invasive infections due to Saccharomyces boulardii have occurred. Most of the patients had gastrointestinal disorders, an intravenous catheter, or ongoing antibiotic treatment. Only 25% of patients were immunosuppressed. (3) Unless the value of this type of treatment based on live microorganisms is demonstrated in methodologically sound clinical trials, it is best to avoid prescribing it to fragile patients.

Supplementation of waste tea fungal biomass as a dietary ingredient for broiler chicks.

The waste tea fungal biomass produced during black tea fermentation was investigated as a dietary ingredient in poultry feeds. A small portion of fungal mat was used as starter culture for the next cycle while the major portion is discarded as waste. Hence a trial study was carried out to utilize the waste fungal biomass as a supplementary diet for broiler chicks. The fungal biomass contained 179.38 g of crude protein, 120 g crude fibre, 4.82 g phosphorus, 6.56 g of calcium and 8.92 MJ metabolizable energy per kilogram of biomass. The dried tea fungus showed phytase activity of 23 IU/mg protein. The supplementation of tea fungal inclusion (TFI) at 150 g/kg concentration in poultry feed increased the feed consumption, body weight, performance efficiency factor (PEF) and the carcass characters of test broilers significantly (P=0.01) over the control. The histopathological examination of liver showed no abnormalities and the mortality rate was zero.

Outbreak of Saccharomyces cerevisiae subtype boulardii fungemia in patients neighboring those treated with a probiotic preparation of the organism.

We report an outbreak of Saccharomyces cerevisiae subtype boulardii fungemia among three intensive care unit roommates of patients receiving lyophilized preparations of this fungus. The fungemia was probably due to central venous catheter contamination and resolved after fluconazole treatment. The need for stringent application of proper hygiene when using a probiotic preparation of this organism is emphasized.

Antipyretic properties of the aqueous and ethanol extracts of the leaves of Ocimum suave and Ocimum lamiifolium in mice.

Numerous plant species are used to treat ailments associated with pyrexia in the indigenous health care delivery system of Ethiopia. Notable among these are Ocimum suave and Ocimum lamiifolium. The objective of the present study was thus to evaluate the antipyretic effects of the aqueous and ethanol extracts of the leaves of Ocimum suave and Ocimum lamiifolium in mice. Rectal temperatures were recorded before and after inducing pyrexia as well as after administration of the respective extracts every half an hour for 3h. Parallel experiments were run with a standard antipyretic (acetylsalicylic acid) and the vehicle (distilled water). All the plant extracts showed antipyretic property with reasonable onset and duration of action. Both ethanol and aqueous extracts of Ocimum suave were observed to be more potent than those of Ocimum lamiifolium. Aqueous extract of Ocimum suave and ethanol extract of Ocimum lamiifolium were more potent than their other counterpart extracts. Time dependent antipyretic effect was also observed with some extracts; reduced with time with aqueous extract of Ocimum suave and increased with time with both extracts of Ocimum lamiifolium.

Seven cases of fungemia with Saccharomyces boulardii in critically ill patients.

Saccharomyces boulardii (Sb) is a particular strain of Saccharomyces cerevisiae (Sc). This viable yeast is used in intensive care adult patients, delivered in packets of 500 mg, for preventing diarrhea associated with antibiotics or enteral feeding at a regimen of 1-2 g/day. Between June 1996 and October 1998, seven cases of fungemia with Sb occurred in a 12-bed intensive care unit (ICU). All the patients concerned were severely ill patients, mechanically ventilated, treated by broad spectrum antibiotics with central venous catheter and were pretreated with Sb, except for one patient. In this study, Sb was identified by specific mycologic methods and confirmed the genomic identity between isolates of blood culture and yeasts from the treatment packets, contrary to a few other reports concerning Saccharomyces species published in international literature. The hypothesis discussed for explaining these cases of Sb fungemia are: (1) an intestinal translocation of Sb administered at a high dosage in severely ill patients, (2) a contamination of the central venous catheter, especially in the patient not pretreated with Sb and (3) a massive colonization of critically ill patients by the yeast as has been reported for Candida species. We note that cases of fungemia with Sc and Sb have become more and more frequent in the international literature during the last 10 years and we do not recommend administering Sb treatment in critically ill patients.

Saccharomyces cerevisiae fungemia in a neutropenic patient treated with Saccharomyces boulardii.

A case of Saccharomyces fungemia in an 8-month-old baby affected by acute myeloid leukemia while receiving intensive chemotherapy is reported. The patient was receiving prophylaxis treatment with Saccharomyces boulardii capsules (Codex) to prevent diarrhea, which is commonly associated with this type of chemotherapy. Fever spiked just the day after ending the chemotherapy course, and a strain of Saccharomyces cerevisiae was isolated from blood culture although the patient was also receiving antifungal prophylaxis with fluconazole. The patient recovered, though still neutropenic, with amphotericin-B and removal of the central venous catheter. The common biochemical characteristics make it difficult to differentiate between the strain of Saccharomyces cerevisiae and that of Saccharomyces boulardii with routine methods. In other cases, authors demonstrated an identity between the two strains with a more detailed analysis. These reports raise concern about the potential side effects of such biotherapeutic agents.

Possible role of catheters in Saccharomyces boulardii fungemia.

Four cases of Saccharomyces boulardii fungemia, a very rare side effect of Saccharomyces boulardii therapy, are reported. The clinical impact of Saccharomyces boulardii infection appeared to be moderate. However, even though organ involvement was never demonstrated, septic shock with no other etiology was observed in one of our patients. All patients had an indwelling vascular catheter. Contamination of the air, environmental surfaces, and hands following the opening of a packet suggests that catheter contamination may have been a source of infection. To prevent catheter contamination it is recommended that packets or capsules of Saccharomyces boulardii be opened with gloves, outside the patient's room.

[Saccharomyces boulardii fungemia in a patient with severe burns]. / Fongémie à Saccharomyces boulardii chez un brûlé grave.

A case of Saccharomyces boulardii fungaemia in a burn patient is reported. S. boulardii was administered in order to improve the digestive tolerance to enteral nutrition. After a surgical procedure, a sepsis syndrome occurred, with a white blood cell count increase, abdominal meteorism and respiratory insufficiency, associated with seven blood cultures positive to S. boulardii. Digestive translocation of the yeast seems to be the most likely origin of this fungaemia. Some fungaemias from S. boulardii have been published. However it is not usual to find such severe clinical features as in our case which leads us to reconsider the therapeutic use of S. boulardii in situations including a gastrointestinal tract suffering.

[Characteristics of structural changes in the internal organs of animals after administration of dried yeast]. / Kharakter strukturnykh izmenenii vnutrennikh organov zhivotnykh pod vliianiem gribnogo poroshka.

Morphofunctional analysis of the state of internal organs was made in rats which received varying amounts of mushroom powder. It has been established that the new product induces development of endovasculitis, dystrophy and lympho-histiocytic infiltrates of parenchymatous organs. The data obtained have evidenced the development of delayed allergic reactions to mushroom powder. A conclusion has been made on the necessity of its limited inclusion into food ration.