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Short-Term Tolerability, Safety, and Gut Microbial Composition Responses to a Multi-Strain Probiotic Supplement: An Open-Label Study in Healthy Adults

Background: Probiotics are among the most commonly used dietary supplements and evidence of their efficacy is increasing. Despite the long historical use of probiotics, some experts suggest that additional research is necessary to understand their potential risks. Objectives: Main aims of this study were to assess short-term tolerability and safety of a new, high colony-forming unit count, multi-strain probiotic supplement. Exploratory objectives included evaluating effects on gut microbial composition. Methods: Ten healthy adults were enrolled in a single-arm, open-label study. Over a 10-day period, participants consumed a once daily probiotic capsule (2.1 x 1011 CFU) containing Lactobacillus acidophilus NCFM, Lactobacillus paracasei Lpc-37, Lactobacillus plantarum Lp-115, Lactobacillus rhamnosus GG, Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis Bl-04, and Bifidobacterium lactis HN019. The primary measure of tolerability pertained to whether or not participants completed the study. Secondary safety measures included clinical biomarkers from a routine metabolic panel and a complete blood count. Exploratory measures included stool microbiota counts. Results: All participants completed the study and there were no serious adverse events. All documented adverse events were prompted by the investigators and the most commonly reported symptoms were gastrointestinal. There was a single instance of a biomarker abnormality in one individual. Overall, decreases in total bilirubin and aspartate aminotransferase, and increases in stool levels of Lactobacillus species, Faecalibacterium prausnitzii, and Akkermansia muciniphila (P < .05) were observed over the course of the study. Conclusions: The findings of this study suggest the multi-strain probiotic supplement was well-tolerated and most likely safe. Changes in liver function measures suggest the probiotics could potentially impact liver health. Stool microbiota changes suggest the probiotic could potentially impact gut health by affecting levels of intestinal microbiota that have been described as bioindicators of health and potential keystone species. However, additional research is necessary to follow up on the exploratory findings of this preliminary work.

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