Best Practices for Probiotic Research in Athletic and Physically Active Populations: Guidance for Future Randomized Controlled Trials

Alex E Mohr, Jamie Pugh, Orla O'Sullivan, Katherine Black, Jeremy R Townsend, David B Pyne, Floris C Wardenaar, Nicholas P West, Corrie M Whisner, Lynne V McFarland, Alex E Mohr, Jamie Pugh, Orla O'Sullivan, Katherine Black, Jeremy R Townsend, David B Pyne, Floris C Wardenaar, Nicholas P West, Corrie M Whisner, Lynne V McFarland

Abstract

Probiotic supplementation, traditionally used for the prevention or treatment of a variety of disease indications, is now recognized in a variety of population groups including athletes and those physically active for improving general health and performance. However, experimental and clinical trials with probiotics commonly suffer from design flaws and different outcome measures, making comparison and synthesis of conclusions difficult. Here we review current randomized controlled trials (RCTs) using probiotics for performance improvement, prevention of common illnesses, or general health, in a specific target population (athletes and those physically active). Future RCTs should address the key elements of (1) properly defining and characterizing a probiotic intervention, (2) study design factors, (3) study population characteristics, and (4) outcome measures, that will allow valid conclusions to be drawn. Careful evaluation and implementation of these elements should yield improved trials, which will better facilitate the generation of evidence-based probiotic supplementation recommendations for athletes and physically active individuals.

Keywords: athletes; clinical trials; guidelines; performance; physical activity; probiotics; study design.

Conflict of interest statement

AM is employed by Isagenix International LLC. Isagenix was not involved in any aspect of the review. JP is a consultant for Aliment Nutrition Ltd. JT has previously received grants to evaluate the efficacy of various nutritional supplements including probiotics. FW received research funding from Royal Friesland Campina N.V., Amersfoort, the Netherlands after this review was drafted. NW has been the recipient of research from DuPont, Chr Hanson, Yakult, Probiotics Australia, UAS Laboratories, and Winclove Probiotics. CW serves on scientific advisory boards for the Wheat Foods Council, Ardent Mills, LLC, and the Hass Avocado Board Avocado Nutrition Science Advisory group. LM is on the Scientific Advisory Board for Bio-K+, Canada and on the Microbiome Advisory Board for Biocodex, France and is a paid lecturer for both companies. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Mohr, Pugh, O'Sullivan, Black, Townsend, Pyne, Wardenaar, West, Whisner and McFarland.

Figures

Figure 1
Figure 1
A framework of best practices for probiotic research in athletic populations. In a context specific manner, properly addressing each of these study elements and strategies is expected to improve clinical trials for probiotics and health outcomes in athletes and physically active individuals.
Figure 2
Figure 2
Probiotic viability considerations for clinical research. (A) Probiotics should have characteristics that promote survivability in the gut. (B) Manufacturers should ensure viable counts of probiotic cells until the end of the shelf life of the product. (C) Probiotic packaging and storage conditions are important for viability. (D) Participants should be instructed on appropriate handling and storage of the probiotic. (E) Viable counts of the probiotic product should be assessed at the start and end of a study to ensure potency is maintained. (F) Researchers may consider assessing participant fecal samples by quantifying the probiotic strain of interest via quantitative polymerase chain reaction (qPCR) to better gauge survivability. (G) Depending on the study design, strain quantification can occur at multiple, strategic time points.
Figure 3
Figure 3
Potential factors that may play a role in GI symptom development either when the athlete is at rest, during exercise with or without peri-exercise feeding, or post exercise. While these factors will not always lead to symptoms, there are a wide range of potential triggers and complaints are likely to be individual. Therefore, there are multiple potential areas probiotics could affect GI symptoms in athletes, broadening the scope for potential research. This schematic also illustrates the large number of confounding factors that should be considered when investigating GI symptoms of athletes. GI, Gastrointestinal.

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