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Probiotics > Module 13- Guidelines > Flashcards

Module 13- Guidelines Flashcards

1
Q

FAO/WHO convened to

A

Generate guidelines and recommend criteria and methodologies for probiotics

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2
Q

FAO/WHO Goal

A

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

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3
Q

Efficacious Trial

A

Phase 2

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4
Q

Effectiveness Trial

A

Phase 3

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5
Q

Labels must have (4)

A

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

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6
Q

Strain specific exceptions

A

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

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7
Q

Key phenotypes for identification purposes

A

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

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8
Q

Strains distributed in…

A

Internationally Recognized Culture Collection

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9
Q

In vitro test used to

A

Screen potential probiotics

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10
Q

Main in vitro test to study probiotic strains (5)

A

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

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11
Q

in vitro test should correlate with…

A

In vivo results

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12
Q

Correlation of in vitro and in vivo example

A

in vitro bile salt resistance and gastric survival in vivo

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13
Q

GRAS status

A

Lactobacilli, Bifidobacteria

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13
Q

4 side effects of probiotics

A

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

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14
Q

No cases of infection from

A

Bifidobacterium

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15
Q

Important cause of nosocomial infection

A

Enterococcus (vancomycin resistant)

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16
Q

All systemic infections are few and in

A

Patients with underlying medical conditions

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17
Q

Infections associated with consumption of commercial products

A

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)

18
Q

Minimum safety tests required (7)

A

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

19
Q

Metabolic activities that need tested

A

D-lactate production + bile salt deconjugation

20
Q

Epidemiological surveillance

A

Post-market adverse incidents of consumers

21
Q

Only needs tested if known producer

A

Toxin and haemolytic activity

22
Q

Add to confidence of safety of probiotic

A

Assessment of lack of infectivity

23
Q

Animal Model use

A

Substantiation + mechanism of probiitc

24
Q

Outcome of efficacy studies on probiotics

A

Proven benefits in human trials

25
Q

Benefits include

A

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

26
Q

Phase 1

A

Safety

27
Q

Phase 2

A

Efficacy

28
Q

Phase 3

A

Effectiveness

29
Q

Phase 4

A

Surveillance

30
Q

Phase 2 type

A

Randomized, double blind, palcebo-controlled (DBPC)

31
Q

Phase 2 mesures

A

Efficacy compared with placebo + adverse effects

32
Q

Placebo

A

Food carrier devoid of test probiotic

33
Q

Calculated for specific end points

A

Sample size

34
Q

Statistical significance in phase II trial

A

Must apply to biologically relevant outcomes

35
Q

Probiotics in food not tested in

A

Phase 3 trials

36
Q

Phase 3 compare

A

Probiotic to standard therapy

37
Q

Phase 3 for

A

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

38
Q

Health claims

A

Only general in food containing probiotics

39
Q

General claim

A

Improves gut health

40
Q

Recommended label information

A

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

41
Q

Probiotics

A

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

42
Q

Promotion of guidelines at

A

International Level

43
Q

GMP

A

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

Probiotics (16 decks)

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