Module 14 - Safety

Question 1

Mainly non-pathogenic

Answer 1

Lactobacillus, Lactococcus, Leuconostoc, oral strep, Bifidobacterium, Saccharomyces

Question 2

Some opportunistic

Answer 2

Lactobacillus, Strep, Enterococcus

Question 3

Haemolytic activity in

Answer 3

Enterococci

Question 4

Safety projects in Europe

Answer 4

LABIP (LAB industrial platform) + PROSAFE + FAIR

Question 5

PROSAFE

Answer 5

Biosafety evaluation of LAB for human consumption

Question 6

FAIR

Answer 6

Functional food science

Question 7

Qualified Presumption of Safety (QPS)

Answer 7

Status via flowchart given by European Union Scientific Committee on Animal Nutrition

Question 8

Three Approaches to Safety Studies

Answer 8

(1) Intrinsic properties of strain
(2) Pharmacokinetics of strain
(3) Interactions between strain and host

Question 9

Pharmacokinetics Studies (4)

Answer 9

Survival, activity on intestine, dose-response relationships, faecal and mucosal recovery

Question 10

Enzymatic properties detrimental to host

Answer 10

Excessive deconjugation of bile salts or degradation of mucus

Question 11

Additional mechanistic studies if…

Answer 11

Bacterial survival differs at different levels of intestine tract + translocation or colonisation properties differ + metabolites produced are different

Question 12

Used to determine colonization properties

Answer 12

Transit markers

Question 13

Used to predict fate of bacteria

Answer 13

In vitro models

Question 14

Predict fate of bacteri

Answer 14

Sensitivity to gastric acid and bile

Question 15

Pharmacokinetics of Probiotics

Answer 15

Fecal of intestinal intubation or colonic biopsy techniqutes + Transit Markers + fate of bacteria

Question 16

Intestinal Cell Lines Test

Answer 16

Adhesion and Invasion + Host Response

Question 17

Animal Models Test

Answer 17

Dose Response + Role of Intestinal Lesions + Immunosuppression

Question 18

Animal Models can Assess

Answer 18

Immunological side effects, Translocation, Immunocompromised patients simulated

Question 19

Lethal Irradiation Model

Answer 19

Simulates Immunocompromised patients

Question 20

Limit of animal models

Answer 20

Microbiological risk assessment

Question 21

Why limited microbiological risk assessment

Answer 21

High variability in species-specific responses

Question 22

Theoretical Adverse Effects of Probiotics

Answer 22

Systemic infections, Deleterious metabolic activities, Adjuvant side-effects and ofimmunomodulation, gene transfer

Question 23

Risk of metabolic activities

Answer 23

None reported for oral

Question 24

Risk of side effects and immunomodulation

Answer 24

None reported

Question 25

Gene Transfer Risk

Answer 25

Several antibiotic resistant plasmids in Lactobacillus + Vancomycin resistant Enterococcus

Question 26

Infections of probiotics

Answer 26

Few traced to fungemia in patients with catheter from Saccharomyces boulardii

Question 27

Infection cases

Answer 27

Few isolated in patients with serious underlying conditions (predisposed to infections)

Question 28

Predisposed to Infections

Answer 28

Abnormal heart valve + Catheter

Question 29

Infection- No side Effects

Answer 29

Chron’s disease + enteritis + AIDs + food LAB

Question 30

Record …. of candidate probiotic

Answer 30

Isolation history and taxonomic classification

Question 31

Manufacturing Controls

Answer 31

Eliminate contamination and cross contamination between batches with microbes or other substances

Question 32

Most consider … for safety

Answer 32

Physiological status of population, dose, method of administration, Allegory materials like dairy proteins