|
Not probiotic
|
| Live or active cultures |
“Contains live and active cultures” |
Any food fermentation microbe(s) |
No product-specific efficacy studies needed |
The terms ‘live’ or ‘active’ do not imply probiotic activity |
| Proof of viability at a minimum level reflective of typical levels seen in fermented foods, suggested to be 1 × 109 CFU per serving73 |
Fermented foods containing live cultures might also qualify as a ‘probiotic’ if they meet the criteria for that category (e.g. evidence that yogurt can improve lactose digestion in lactose maldigesters would qualify it as a ‘probiotic’74,75) |
|
Probiotic
|
| Probiotic in food or supplement without health claim |
“Contains probiotics” |
A member(s) of a safe76,77 species, which is supported by sufficient evidence of a general beneficial effect in humans OR a safe microbe(s) with a property (e.g. a structure, activity or end product) for which there is sufficient evidence for a general beneficial effect in humans |
Well-conducted human studies (e.g. these could involve RCT(s), observational studies, systematic reviews or meta-analyses supporting the observed general beneficial effect for the taxonomical category concerned) |
Extrapolation of evidence must be based on reasonable expectations that the strain(s) incorporated in the product would have similar general beneficial effects in humans |
| Proof of viability at the appropriate level used in supporting human studies73 |
The evidence does not have to be generated for the specific strain included in the product |
This evidence could be based on taxonomical or functional comparisons |
| Probiotic in food or supplement with a specific health claim |
Specific health claim, such as “helps to reinforce the body’s natural defences in children” or “helps reduce the risk of antibiotic-associated diarrhoea” |
Defined probiotic strain(s) |
Convincing evidence needed for specific strain(s) or strain combination in the specified health indication |
Well-designed observational studies are useful to detect the effect of foods on health in ‘real life’, that is, outside the controlled environment of an RCT (e.g. data on health benefits by dietary fibre are mostly observational) |
| Proof of delivery of viable strain(s) at efficacious dose at end of shelf-life73 |
Such evidence includes well-conducted studies in humans, including: positive meta-analyses on specific strain(s) or strain combinations, as per principles outlined by Cochrane,78 PASSCLAIM,79 or GRADE;80 well-conducted RCT(s) OR strong evidence from large observational studies81 |
Sample sizes must be large enough to manage confounding factors |
| Probiotic drug |
Specific indication for treatment or prevention of disease, such as “useful for the prevention of relapse of ulcerative colitis” |
A defined strain(s) of live microbe |
Appropriate trials to meet regulatory standards for drugs |
What constitutes a drug claim varies among countries |
| Proof of delivery of viable probiotic at efficacious dose at end of shelf-life |
| Risk-benefit assessment justifies use |
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