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11

Mar 2026

When Does a Probiotic Need a Clinical Trial?
When Does a Probiotic Need a Clinical Trial?
By
Not every probiotic product requires a clinical trial. Many probiotic strains already have a body of published evidence, and regulatory frameworks for dietary supplements and foods do not always mandate […] Read More >>

11

Mar 2026

Designing a Probiotic Clinical Trial: Key Decisions Sponsors Must Get Right
Designing a Probiotic Clinical Trial: Key Decisions Sponsors Must Get Right
By
Probiotic trials rarely fail for a single reason. More often, problems emerge from a series of early design decisions that were never fully aligned: the strain chosen doesn’t match the […] Read More >>

27

Feb 2026

Sample size calculations for probiotic trials: What sponsors get wrong
Sample size calculations for probiotic trials: What sponsors get wrong
By
Probiotic trials are frequently underpowered—not because sponsors ignore statistics, but because they underestimate how different probiotics are from conventional nutraceuticals. Unlike single-molecule ingredients, probiotics are living systems. Their ef Read More >>

26

Feb 2026

Which endpoint should you pick for your probiotic study?
Which endpoint should you pick for your probiotic study?
By
Probiotic trials don’t fail only because a strain “doesn’t work.” Many fail because the endpoint doesn’t match the claim, the population, or the biology of a living product—and the study […] Read More >>

22

Feb 2019

Changes in the Dietary Supplement Environment: Is your Product Compliant?
Changes in the Dietary Supplement Environment: Is your Product Compliant?
By
On February 11, 2019, FDA Commissioner Dr. Scott Gottlieb announced that the regulatory framework for dietary supplements is expected to change. It has been determined that changes are necessary due […] Read More >>
New Blood Pressure Guidelines in the U.S. – How does this Update affect your Structure-Function Claim Substantiation for a Dietary Supplement?
January 17, 2018 By
    The definition of blood pressure and its associated guidelines have recently been updated in the United States. Previously, high blood pressure was defined by the threshold blood pressure […] Read More >>

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