Impact of probiotic supplementation on exercise endurance among non-elite athletes: study protocol for a randomized, placebo-controlled, double-blind, clinical trial.

BACKGROUND: Some probiotics appear to improve athletic performance, endurance, and recovery after intense exercise. Other formulations may provide performance-related benefits via immune and gastrointestinal functions in athletic individuals. However, few formulations have been studied for both types of effects among non-elite athletes. The primary objective of this study is to assess the ergogenic effects of a probiotic on high-intensity endurance running performance in non-elite runners. Secondary objectives include assessment of perceived exertion, blood chemistry, immune and stress biomarkers, cold and flu symptoms, and gastrointestinal health after the probiotic intervention. METHODS: This 9-week randomized, placebo-controlled, double-blind, parallel trial will assess the ergogenic effects of a probiotic (5 billion colony-forming units/day, for 6 weeks) in healthy, non-elite runners (N=32; 18-45 years). Participants will be monitored via daily and weekly questionnaires during the 2-week pre-baseline, 6-week intervention, and 1-week washout. Questionnaires will inquire about activity, muscle soreness, gastrointestinal symptoms, cold and flu symptoms, stool form and frequency, and adverse events. During the pre-baseline visit, maximal oxygen uptake (V̇O2 max) is assessed to set appropriate individualized workload settings for the treadmill time-to-exhaustion endurance tests. These time-to-exhaustion endurance running tests will be completed at an intensity of 85% VO2max at baseline and final visits. During these tests, self-perceived exercise effort will be rated via the Borg Rating of Perceived Exertion scale and finger sticks assessing capillary blood glucose and lactate concentrations will be collected every 3 min. Additional questionnaires will assess diet and motivation to exercise. Body composition will be assessed using air displacement plethysmography at the baseline and final visits. Hypotheses will be tested using two-sided tests, and a linear model and with a type I error rate of α=0.05. Primary and secondary outcomes will be tested by comparing results between the intervention groups, adjusting for baseline values. DISCUSSION: These results will build evidence documenting the role of probiotics on running endurance performance and physiological responses to exercise in non-elite athletes. Understanding the potential mechanisms of probiotic effects and how they mitigate the intestinal or immune discomforts caused by running could provide additional strategy means to help runners improve their performance. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT04588142 . Posted on October 19, 2020. PROTOCOL VERSION: July 2, 2021, version 1.2.

Safety and efficacy of probiotic supplements as adjunctive therapies in patients with COVID-19: A systematic review and meta-analysis.

BACKGROUND AND AIMS: Oral probiotic supplementation may be a beneficial adjunctive therapy for patients with symptomatic COVID-19. However, its safety and efficacy are unclear. We aimed to investigate how probiotic supplementation impacts COVID-19 symptom trajectory and patient outcomes by conducting a systematic review and meta-analysis of randomized controlled trials (RCTs). METHODS: RCTs randomizing patients with COVID-19 to probiotics were searched in PubMed Central, Embase, CINAHL, and Cochrane Library from inception to July 31, 2022. We performed a random-effects pairwise meta-analysis for all outcomes using the restricted maximum likelihood (REML) estimator. We used the GRADE approach to assess the certainty of the evidence. RESULTS: A total of 1027 participants from eight RCT studies were included in the meta-analysis. Probiotic supplements probably reduce the incidence of diarrhea (RR 0.61 [0.43 to 0.87]; moderate certainty) and probably reduce cough or dyspnea compared to placebo/standard care (RR 0.37 [0.19 to 0.73]; moderate certainty). Probiotic supplements may improve composite endpoint measured by clinical escalation or mortality compared to placebo (RR 0.41 [0.18 to 0.93]; low certainty evidence); however, they may not significantly reduce the need for clinical escalation (RR 0.57 [0.31 to 1.07]; low certainty evidence) or mortality (RR 0.50 [0.20 to 1.29]; low certainty evidence). In addition, the probiotic supplement is associated with reduced adverse events (RR 0.62 [0.46 to 0.83]; moderate certainty). CONCLUSION: Early probiotic supplement is a safe and effective adjunctive therapy that reduces the risk of symptoms and health care burden related to COVID-19 across all severity types.

Clinical efficacy of probiotics in the treatment of patients with COVID-19: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVES: This study was conducted to assess the clinical efficacy of probiotics in the treatment of patients with COVID19. METHODS: PubMed, Embase, Cochrane Library, and ClinicalTrials.gov were searched for studies from their inception to 8 February 2022. Randomized controlled trials (RCTs) that compared the clinical efficacy of probiotics with usual care or standard care for patients with COVID19 were included. The primary outcome was all-cause mortality. Random-effects model using MantelHaenszel and inverse variance methods were performed to analyze the data. RESULTS: Eight RCTs with 900 patients were included. The study group receiving probiotics had a non-significantly lower rate of mortality than the control group had, but this difference was not significant (risk ratio [RR], 0.51; 95% CI, 0.22 to 1.16). However, the study group had significantly lower rates of dyspnea (RR, 0.11; 95% CI, 0.02 to 0.60), fever (RR, 0.37; 95% CI, 0.16 to 0.85) and headache (RR, 0.19; 95% CI, 0.05 to 0.65). Higher complete remission of COVID-19-associated symptoms was observed in the study group than the control group (RR, 1.89; 95% CI, 1.40-2.55). CONCLUSIONS: Although probiotics use did not improve clinical outcomes or reduce inflammatory markers, it may relieve COVID-19-associated symptoms.

Lactobacillus rhamnosus sepsis, endocarditis and septic emboli in a patient with ulcerative colitis taking probiotics.

A man in his 60s presented to the emergency room with fever and fatigue after a 2.5-month course of corticosteroids. His medical history was significant for bioprosthetic aortic valve replacement and moderately severe ulcerative colitis treated with balsalazide and daily lactobacillus-containing probiotics. Initial investigations revealed Lactobacillus rhamnosus bacteraemia without complication. Four days after hospital discharge, the patient experienced acute-onset right-sided paraesthesia and lower-limb paresis. On return to the emergency room, MRI of the brain demonstrated innumerable ring-enhancing lesions with haemorrhagic transformation. Transoesophageal echocardiogram revealed a small mobile density on the bioprosthetic aortic valve, raising the suspicion for L. rhamnosus infective endocarditis with secondary septic emboli to the brain. The patient was subsequently treated with intravenous gentamycin and ampicillin, with transition to indefinite oral amoxicillin suppressive therapy. The current case highlights the potential risk of lactobacilli translocation in an immunosuppressed patient with ulcerative colitis taking probiotics.

Oral booster probiotic bifidobacteria in SARS-COV-2 patients.

Oral booster-single strain probiotic bifidobacteria could be a potential strategy for SARS-CoV-2. This study aims to evaluate the role of oral probiotic Bifidobacterium on moderate/severe SARS-CoV-2 inpatients. In this single-center study, we analyzed data of 44 moderate/severe inpatients with diagnosed COVID-19 in Istanbul Maltepe University Medical Faculty Hospital, 2020 from 1 November 2020 to 15 December 2020. Clinical and medication features were compared and analyzed between patients with or without probiotic. In result, 19 of the 44 patients (43.18%) who were administrated with oral booster-single strain probiotic were discharged with the median inpatient day of 7.6 days which were significantly shorter than those of patients without probiotic. There were significant differences in inpatient days, radiological improvement at day 6 and week 3, and reduction in interleukin-6 levels in those receiving oral probiotic therapy. Although the mortality rate was 5% in the probiotic group, it was 25% in the non-probiotic group. Booster-single strain probiotic bifidobacteria could be an effective treatment strategy for moderate/severe SARS-CoV-2 inpatients to reduce the mortality and length of stay in hospital.

Probiotics: Versatile Bioactive Components in Promoting Human Health.

The positive impact of probiotic strains on human health has become more evident than ever before. Often delivered through food, dietary products, supplements, and drugs, different legislations for safety and efficacy issues have been prepared. Furthermore, regulatory agencies have addressed various approaches toward these products, whether they authorize claims mentioning a disease's diagnosis, prevention, or treatment. Due to the diversity of bacteria and yeast strains, strict approaches have been designed to assess for side effects and post-market surveillance. One of the most essential delivery systems of probiotics is within food, due to the great beneficial health effects of this system compared to pharmaceutical products and also due to the increasing importance of food and nutrition. Modern lifestyle or various diseases lead to an imbalance of the intestinal flora. Nonetheless, as the amount of probiotic use needs accurate calculations, different factors should also be taken into consideration. One of the novelties of this review is the presentation of the beneficial effects of the administration of probiotics as a potential adjuvant therapy in COVID-19. Thus, this paper provides an integrative overview of different aspects of probiotics, from human health care applications to safety, quality, and control.