Module 13- Guidelines

Question 1

FAO/WHO convened to

Answer 1

Generate guidelines and recommend criteria and methodologies for probiotics

Question 2

FAO/WHO Goal

Answer 2

Identify and define what data needs to be available to accurately substantiate health claims

Question 3

Efficacious Trial

Answer 3

Phase 2

Question 4

Effectiveness Trial

Answer 4

Phase 3

Question 5

Labels must have (4)

Answer 5

Contents (genus, species, strain) + minimal number of viable bacteria at end of shelf life + storage conditions + corporate contact details

Question 6

Strain specific exceptions

Answer 6

General ability of S. thermophilus and L. delbrueckii spp. bulgaricus to enhance lactose digestion in lactose intolerant individuals

Question 7

Key phenotypes for identification purposes

Answer 7

Fermentation patterns of sugars + final products of fermentation from glucose utilisation

Question 8

Strains distributed in…

Answer 8

Internationally Recognized Culture Collection

Question 9

In vitro test used to

Answer 9

Screen potential probiotics

Question 10

Main in vitro test to study probiotic strains (5)

Answer 10

Resistance to gastric acidity and bile acids, adherence to mucus/epi cells, AM activity and reduction of pathogen adherence, bile salt hydrolase activity, resistance to spermicides

Question 11

in vitro test should correlate with…

Answer 11

In vivo results

Question 12

Correlation of in vitro and in vivo example

Answer 12

in vitro bile salt resistance and gastric survival in vivo

Question 13

GRAS status

Answer 13

Lactobacilli, Bifidobacteria

Question 13

4 side effects of probiotics

Answer 13

systemic infections, deleterious metabolic activities, excessive immune stimulation in susceptible, Gene transfer

Question 14

No cases of infection from

Answer 14

Bifidobacterium

Question 15

Important cause of nosocomial infection

Answer 15

Enterococcus (vancomycin resistant)

Question 16

All systemic infections are few and in

Answer 16

Patients with underlying medical conditions

Question 17

Infections associated with consumption of commercial products

Answer 17

L. rhamnosus (2 cases) + Saccharomyces fungemia due to vascular catheter (13 cases) + Bacillus subtilis bacteremia, septicemia, cholangitis and probiotics (7 cases in pateints with underlying disease)

Question 18

Minimum safety tests required (7)

Answer 18

Antibiotic resistance, metabolic activities, side effects in human studies, epidemiological surveillance, toxin production, haemolytic activity, Lack of infectivity in immunocompromised animals

Question 19

Metabolic activities that need tested

Answer 19

D-lactate production + bile salt deconjugation

Question 20

Epidemiological surveillance

Answer 20

Post-market adverse incidents of consumers

Question 21

Only needs tested if known producer

Answer 21

Toxin and haemolytic activity

Question 22

Add to confidence of safety of probiotic

Answer 22

Assessment of lack of infectivity

Question 23

Animal Model use

Answer 23

Substantiation + mechanism of probiitc

Question 24

Outcome of efficacy studies on probiotics

Answer 24

Proven benefits in human trials

Question 25

Benefits include

Answer 25

Statistically and biologically significant improvements in conditions, symptoms, signs, well-being or quality of life; reduce disease risk; longer time to next occurrence of disease; faster recovery

Question 26

Phase 1

Answer 26

Safety

Question 27

Phase 2

Answer 27

Efficacy

Question 28

Phase 3

Answer 28

Effectiveness

Question 29

Phase 4

Answer 29

Surveillance

Question 30

Phase 2 type

Answer 30

Randomized, double blind, palcebo-controlled (DBPC)

Question 31

Phase 2 mesures

Answer 31

Efficacy compared with placebo + adverse effects

Question 32

Placebo

Answer 32

Food carrier devoid of test probiotic

Question 33

Calculated for specific end points

Answer 33

Sample size

Question 34

Statistical significance in phase II trial

Answer 34

Must apply to biologically relevant outcomes

Question 35

Probiotics in food not tested in

Answer 35

Phase 3 trials

Question 36

Phase 3 compare

Answer 36

Probiotic to standard therapy

Question 37

Phase 3 for

Answer 37

Claim that alters disease state --> based on sound evidence in humans

Question 38

Health claims

Answer 38

Only general in food containing probiotics

Question 39

General claim

Answer 39

Improves gut health

Question 40

Recommended label information

Answer 40

Strain should not mislead about function, viable numbers at end of life, serving size must deliver effective dose, health claims, storage, corporate contact

Question 41

Probiotics

Answer 41

Live microbes which when administered in adequate amounts confer health benefit on host

Question 42

Promotion of guidelines at

Answer 42

International Level

Question 43

GMP

Answer 43

Must be applied to probiotic foods with quality assurance and shelf life established