Consumption by Healthy Adults of Pasteurized Milk with a High Concentration of Bacillus cereus: A Double-Blind Study

1996 ◽  
Vol 59 (7) ◽  
pp. 723-726 ◽  
Author(s):  
LEO P. M. LANGEVELD ◽  
WILLEM A. VAN SPRONSEN ◽  
EMERENTIA C. H. VAN BERESTEIJN ◽  
SERVÉ H. W. NOTERMANS
Keyword(s):  
Bacillus Cereus ◽  
Healthy Adults ◽  
Double Blind Study ◽  
High Concentration ◽  
Healthy Human ◽  
Double Blind ◽  
Pasteurized Milk ◽  
Human Volunteers ◽  
Pure Cultures ◽  
Gastrointestinal Complaints

A double-blind experiment with 34 healthy human volunteers, aged between 20 and 60 years, was conducted to obtain information about the allowable concentration of B. cereus in pasteurized milk. During a period of 3 weeks the subjects were exposed to B. cereus naturally present in pasteurized milk following storage for 3 to 14 days at 7.5°C. Of 259 milk exposures, gastrointestinal complaints were observed in 18 cases. According to total numbers of B. cereus ingested per exposure the complaints per number of exposures were distributed as follows: < 106: 5 in 132; 106 to 107: 2 in 32; 107 to 108 : 2 in 26; and > 108: 9 in 69. Symptoms, however, were not typical of those caused by B. cereus. There was a weak significance (P ≤ 0.1) for symptoms when > 108 B. cereus cells were ingested. Milk with 106 to 107 B. cereus cells per ml showed a very low diarrheal enterotoxin titer. Pure cultures of B. cereus strains isolated from samples with high B. cereus concentrations also showed a low production of enterotoxin. It can be concluded that for healthy adults the probability of become diseased from cold-stored pasteurized milk is small. From the results no evidence is obtained that B. cereus concentrations less than 105/ml will cause intoxication.

scholarly journals Prebiotic effect of fruit and vegetable shots containing Jerusalem artichoke inulin: a human intervention study

2010 ◽  
Vol 104 (2) ◽  
pp. 233-240 ◽  
Author(s):  
P. Ramnani ◽  
E. Gaudier ◽  
M. Bingham ◽  
P. van Bruggen ◽  
K. M. Tuohy ◽  
...  
Keyword(s):  
Jerusalem Artichoke ◽  
Double Blind Study ◽  
Fruit And Vegetable ◽  
Healthy Human ◽  
Double Blind ◽  
Human Volunteers ◽  
High Level ◽  
Age Range ◽  
Bacterial Groups

The present study aimed to determine the prebiotic effect of fruit and vegetable shots containing inulin derived from Jerusalem artichoke (JA). A three-arm parallel, placebo-controlled, double-blind study was carried out with sixty-six healthy human volunteers (thirty-three men and thirty-three women, age range: 18–50 years). Subjects were randomised into three groups (n22) assigned to consume either the test shots, pear-carrot-sea buckthorn (PCS) or plum-pear-beetroot (PPB), containing JA inulin (5 g/d) or the placebo. Fluorescentin situhybridisation was used to monitor populations of total bacteria, bacteroides, bifidobacteria,Clostridium perfringens/histolyticumsubgroup,Eubacterium rectale/Clostridium coccoidesgroup, Lactobacillus/Enterococcusspp.,Atopobiumspp.,Faecalibacterium prausnitziiand propionibacteria. Bifidobacteria levels were significantly higher on consumption of both the PCS and PPB shots (10·0 (sd0·24) and 9·8 (sd0·22) log10cells/g faeces, respectively) compared with placebo (9·3 (sd0·42) log10cells/g faeces) (P < 0·0001). A small though significant increase inLactobacillus/Enterococcusgroup was also observed for both the PCS and PPB shots (8·3 (sd0·49) and 8·3 (sd0·36) log10cells/g faeces, respectively) compared with placebo (8·1 (sd0·37) log10cells/g faeces) (P = 0·042). Other bacterial groups and faecal SCFA concentrations remained unaffected. No extremities were seen in the adverse events, medication or bowel habits. A slight significant increase in flatulence was reported in the subjects consuming the PCS and PPB shots compared with placebo, but overall flatulence levels remained mild. A very high level of compliance (>90 %) to the product was observed. The present study confirms the prebiotic efficacy of fruit and vegetable shots containing JA inulin.

The Effect of Warfarin Sodium on the Duration of Platelet Aggregation

1967 ◽  
Vol 18 (03/04) ◽  
pp. 766-778 ◽  
Author(s):  
H. J Knieriem ◽  
A. B Chandler
Keyword(s):  
Platelet Count ◽  
Placebo Group ◽  
Platelet Aggregation ◽  
Prothrombin Time ◽  
Platelet Rich Plasma ◽  
Healthy Adults ◽  
Double Blind Study ◽  
Double Blind ◽  
Warfarin Sodium

SummaryThe effect of the administration of warfarin sodium (Coumadin®) on the duration of platelet aggregation in vitro was studied. Coumadin was given for 4 consecutive days to 10 healthy adults who were followed over a period of 9 days. The duration of adenosine diphosphate-induced platelet aggregation in platelet-rich plasma, the prothrombin time, and the platelet count of platelet-rich plasma were measured. Four other healthy adults received placebos and participated in a double-blind study with those receiving Coumadin.Although administration of Coumadin caused a prolongation of the prothrombin time to 2 or 21/2 times the normal value, a decrease in the duration of platelet aggregation was not observed. In most individuals who received Coumadin an increase in the duration of platelet aggregation occurred. The effect of Coumadin on platelet aggregation was not consistently related to the prothrombin time or to the platelet count. In the placebo group there was a distinct relation between the duration of platelet aggregation and the platelet count in platelet-rich plasma.The mean increase in the duration of platelet aggregation when compared to the control value before medication with Coumadin was 37.7%. In the placebo group there was a mean increase of 8.4%. The difference between the two groups is significant (p <0.001). Increased duration of platelet aggregation also occurred in two individuals who received Coumadin over a period of 10 and 16 days respectively.

Patient Tolerance to Intravenous Potassium Chloride with and without Lidocaine

1988 ◽  
Vol 22 (9) ◽  
pp. 676-679 ◽  
Author(s):  
Frank Pucino ◽  
Byron D. Danielson ◽  
James D. Carlson ◽  
Gordon L. Strommen ◽  
Paul R. Walker ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Potassium Chloride ◽  
Pain Perception ◽  
Double Blind Study ◽  
High Concentration ◽  
Electrolyte Abnormality ◽  
Double Blind ◽  
Visual Analog Scales ◽  
Patient Tolerance ◽  
Infusion Period

Hypokalemia is a common electrolyte abnormality. Intravenous repletion therapy with potassium chloride (KCl) in concentrations > 80-100 mEq/L is not recommended due to patient intolerance. Since this guideline at times may be clinically impractical, this study was designed to examine use of peripheral vein infusions of high concentration KCl therapy. Tolerance to KG 20 mEq/65 ml iv with and without lidocaine 50 mg was evaluated in 18 hypokalemic subjects in a randomized, placebo-controlled, double-blind study. Subjective and objective assessments of adverse effects were determined throughout the infusion period. Pain was assessed by both verbal descriptor and visual analog scales and correlated significantly following infusion of KCl with or without lidocaine. Multivariant analysis demonstrated differences in pain perception between solutions, with significantly less pain following KCl with lidocaine versus KCl infusions. Transient adverse effects occurred in both groups, but the incidence was not statistically different. Use of concentrated iv KCl infusions may benefit hypokalemic patients with hypervolemia and/or severe potassium deficits. Addition of lidocaine clearly improves patient tolerance to intravenous KCl replacement.

Probiotic lactobacilli and bifidobacteria in a fermented milk product with added fruit preparation reduce antibiotic associated diarrhea andHelicobacter pyloriactivity

2011 ◽  
Vol 78 (4) ◽  
pp. 396-403 ◽  
Author(s):  
Michael de Vrese ◽  
Holger Kristen ◽  
Peter Rautenberg ◽  
Christiane Laue ◽  
Jürgen Schrezenmeir
Keyword(s):  
Lactic Acid ◽  
Intervention Group ◽  
Eradication Therapy ◽  
Fermented Milk ◽  
Probiotic Bacteria ◽  
Double Blind Study ◽  
Milk Product ◽  
Double Blind ◽  
Milk Products ◽  
Gastrointestinal Complaints

To investigate matrix-specifity of probiotic effects and particularly of the reduction of antibiotics-associated diarrhea, a controlled, randomized, double-blind study was performed, in which 88Helicobacter pylori-infected but otherwise healthy subjects were given for eight weeks either a) a probiotic fruit yoghurt “mild” containingLactobacillus acidophilusLA-5 plusBifidobacterium lactisBB-12,n=30), b) the same product but pasteurized after fermentation (n=29) or c) milk acidified with lactic acid (control,n=29). During week five, aHelicobactereradication therapy was performed.Helicobacteractivity was measured via13C-2-urea breath tests and antibiotic-associated diarrhoea and other gastrointestinal complaints were recorded by validated questionnaires. In intervention group a, b and c the mean number of days with diarrhoea was 4, 10 and 10 (P<0·05), the frequency of episodes 17%, 7% and 27% (n.s.), and the change in total symptoms score before antibiotics treatment was −1·4±1·1, −1·2±1·1, 2·6±1·1 points/four weeks (P<0·05). All milk products decreasedHelicobacteractivity by 18 to 45% without significant differences between groups. The observed decrease inHel. pyloriactivity seems to be not or not only due to probiotic bacteria but (rather) to components of acidified milk (most probably lactic acid). Fruit-yogurt-like fermented milk products with living probiotic bacteria significantly shorten the duration of antibiotics-associated diarrhoea and improve gastrointestinal complaints. Fruit yogurt-like fermented milk is a matrix suitable for probiotic bacteria.

scholarly journals Immunogenicity, Lot Consistency, and Extended Safety of rVSVΔG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults

2019 ◽  
Vol 220 (7) ◽  
pp. 1127-1135 ◽  
Author(s):  
Scott A Halperin ◽  
Rituparna Das ◽  
Matthew T Onorato ◽  
Kenneth Liu ◽  
Jason Martin ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ebola Virus ◽  
Geometric Mean ◽  
Healthy Adults ◽  
Controlled Study ◽  
Enzyme Linked Immunosorbent Assay ◽  
High Dose ◽  
Double Blind Study ◽  
Virus Envelope ◽  
Double Blind

Abstract Background This double-blind study assessed immunogenicity, lot consistency, and safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP). Methods Healthy adults (N = 1197) were randomized 2:2:2:2:1 to receive 1 of 3 consistency lots of rVSVΔG-ZEBOV-GP (2 × 107 plaque-forming units [pfu]), high-dose 1 × 108 pfu, or placebo. Antibody responses pre-/postvaccination (28 days, 6 months; in a subset [n = 566], months 12, 18, and 24) were measured. post hoc analysis of risk factors associated with arthritis following vaccination was performed. Results ZEBOV-GP enzyme-linked immunosorbent assay (ELISA) geometric mean titers (GMTs) increased postvaccination in all rVSVΔG-ZEBOV-GP groups by 28 days (>58-fold) and persisted through 24 months. The 3 manufacturing lots demonstrated equivalent immunogenicity at 28 days. Neutralizing antibody GMTs increased by 28 days in all rVSVΔG-ZEBOV-GP groups, peaking at 18 months with no decrease through 24 months. At 28 days, ≥94% of vaccine recipients seroresponded (ZEBOV-GP ELISA, ≥2-fold increase, titer ≥200 EU/mL), with responses persisting at 24 months in ≥91%. Female sex and a history of arthritis were identified as potential risk factors for the development of arthritis postvaccination. Conclusions Immune responses to rVSVΔG-ZEBOV-GP persisted to 24 months. Immunogenicity and safety results support continued rVSVΔG-ZEBOV-GP development. Clinical Trials Registration NCT02503202.

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