Clinical Guide to Probiotic Products Available in USA

Applications, Dosage Forms and Clinical Evidence to Date - 2024 Edition


WHAT is this:
A Practice Tool to Assist with Clinical Decision Making for Appropriate Probiotic Therapy for Your Patients
WHO is the intended user:
This Clinical Guide is designed to translate scientific evidence available for probiotic products to practical, clinically relevant information. It is intended to be used as a clinical decision-making tool, enabling clinicians to easily select the appropriate product, dose, and formulation for a specific indication.
WHY is this needed:
Currently, the body of evidence for probiotic interventions is growing along with popular demand for these products. There is evidence to support the use of probiotic products for a variety of indications beyond gut health, however applications and results are strain-specific. Due to frequent changes in commercial availability of probiotic strains, new published evidence, and growing research, an annual review and updates of this Clinical Guide have been conducted since 2008.
A general lack of adverse effects attributable to probiotics supports the widespread use of these products but an ongoing investigation is recommended.

HOW is this tool reviewed:
A systematic literature review using pre-defined inclusion criteria was undertaken to identify studies of defined clinical outcomes for specific probiotic strain(s). Commercially available products containing said strain(s) were identified, and the levels of evidence were used to rate the strength of expected benefit. This information was compiled into a chart format. Data were assessed by a group of independent expert reviewers.
In the case of probiotics, the clinical evidence must be linked to specific formulations as defined by genus, species, alphanumeric designation or strain, number of live bacteria present, the blend of probiotic strains present and finally, non-active ingredients present.
Every attempt was made by the author and reviewers to include the published clinical data for the available probiotic formulations. To avoid selection bias toward any specific formulation, we have conducted a literature search of two databases (PubMed, EMBASE) and contacted our independent experts to identify any published or unpublished studies.
Our aim is to ensure that the appropriate product/strain is selected for the desired outcome. This Clinical Guide is not meant to be interpreted as a systematic review, or a “clinical practice guideline”, nor is it an endorsement for companies to market health claims.
Readers are strongly encouraged to review the evidence listed for each product for themselves. Please refer to individual publications for specifics of patient populations studied e.g. age, gender, comorbidities) and details of clinical effect (statistical significance, size of treatment effect, the precision of the confidence intervals).

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Level of Recommendation
Level I
Evidence obtained from at least one appropriately designed trial, (e.g., randomization, blinding, appropriate population comparisons) with a power calculation for the outcome(s) of interest. The expert review board reserves the right to make the final decision for the level of recommendation. (HIGHEST LEVEL)
Level II
Evidence obtained from well-designed controlled trials without randomization; evidence obtained from randomized trials not satisfying all criteria listed in Level I.Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence
Level III
Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees

WHY are only a limited number of products included?

All of the Inclusion criteria listed below must be satisfied for a product to be listed in this clinical guide:

1. Commercially available in the United States as a dietary supplement or probiotic-containing food
2. Generally Recognized as Safe status (FDA) and/or Natural Product Number (Health Canada) for probiotic strain(s) used in the products
3. Favorable published clinical evidence for the particular strain(s) present in each product/food
4. For products containing multiple strains, the evidence must be for the specified combination and NOT extrapolated from the evidence for the separate probiotic strains

Note: Some products are excluded from the current edition due to changes in strains used

Clinical Pearl: Indications for use are based on specific strains or combinations studied together

Caution: Extrapolation of current data and recommendations to be applied for different combinations of probiotic strains is not permitted.

DISCLAIMER

The statements made regarding products listed here have not been evaluated by the Food and Drug Administration or Health Canada (unless otherwise indicated). Information in this guide is not intended to diagnose, treat, cure, or prevent any disease. Products, services, information and other content provided on this Site, including information that may be provided on this Site directly or by linking to third-party websites are provided for informational purposes only. Please consult with a physician or other healthcare professional regarding any medical or health-related questions. Manufacturer indications for use can be found on product labels. This chart is reflective of published evidence available to date. It does not represent an endorsement of any specific product. Work on this guide is done independently and without financial conflict. In order to minimize bias, publishing and distribution efforts are coordinated via Alliance for Education on Probiotics (AEProbio). We are grateful for unrestricted publishing grant AEProbio is providing for continuous efforts to translate science into clinically applicable form.
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