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Lacticaseibacillus paracasei Lpc-37® improves psychological and physiological markers of stress and anxiety in healthy adults: a randomized, double-blind, placebo-controlled and parallel clinical trial (the Sisu study).

ABSTRACT: Chronic stress is a risk-factor for the development of mood and stress-related disorders. Clinical evidence indicates that probiotics can influence the stress response and mood. The Sisu study investigated whether Lacticaseibacillus paracasei Lpc-37® (Lpc-37®) could modulate stress, mood and well-being. Prior to a two-week run-in period, 120 healthy adults (18-45 y) were stratified for sex and chronic stress and randomized to either 1.75 × 10¹⁰ colony forming units (CFU) of Lpc-37 or placebo (1:1) per day for 5 weeks. The primary objective was the effect of Lpc-37 on heart rate (HR) in response to the Trier Social Stress Test (TSST). Secondary objectives were assessed by biomarkers and self-report scales over the study. The primary hypothesis was not met in either the Intention-to-Treat (ITT) or Per Protocol (PP) population, but Lpc-37 reduced the increase in HR in participants with low chronic stress (LCS) and increased HR in participants with high chronic stress (HCS) during the TSST. Supporting significant efficacy in the PP population (n = 113), Lpc-37 reduced perceived stress following intervention. More significant effects were identified within the subgroups where Lpc-37 reduced exhaustion during the TSST and normalized cortisol levels at 8pm in participants with LCS, reduced perceived stress also in females, and increased perceived health and sleep-related recovery in participants with HCS. Adverse events (AEs) were similar between groups, there were no severe AEs, and vital signs remained unchanged. Overall, Lpc-37 reduced perceived stress compared to placebo. Other beneficial effects within biomarkers related to stress indicate that the effects of Lpc-37 may be differentially dependent on sex and chronic stress. (ClinicalTrials.gov: NCT03494725).

SUBMITTER: Patterson E

PROVIDER: S-EPMC7770962 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Lacticaseibacillus paracasei Lpc-37® improves psychological and physiological markers of stress and anxiety in healthy adults: a randomized, double-blind, placebo-controlled and parallel clinical trial (the Sisu study).

Patterson Elaine E Griffin Síle M SM Ibarra Alvin A Ellsiepen Emilia E Hellhammer Juliane J

Neurobiology of stress 20201124

Chronic stress is a risk-factor for the development of mood and stress-related disorders. Clinical evidence indicates that probiotics can influence the stress response and mood. The Sisu study investigated whether Lacticaseibacillus paracasei Lpc-37® (Lpc-37®) could modulate stress, mood and well-being. Prior to a two-week run-in period, 120 healthy adults (18-45 y) were stratified for sex and chronic stress and randomized to either 1.75 × 1010 colony forming units (CFU) of Lpc ...[more]

PMID: 33385020

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Project description:Lacticaseibacillus paracasei Lpc-37 (Lpc-37) has previously shown to reduce perceived stress in healthy adults. The ChillEx study investigated whether Lpc-37 reduces stress in a model of chronic examination stress in healthy students. One hundred ninety university students (18-40 y) were randomized to take 1.56 × 1010 colony-forming units of Lpc-37 or placebo (1:1) each day for 10 weeks, in a triple-blind, parallel, multicenter clinical trial consisting of six visits: two screening visits, a baseline visit, and visits at 4, 8, and 10 weeks after baseline. The primary objective was to demonstrate that Lpc-37 reduces stress, as measured by the change in state anxiety from baseline to just before the first examination, after 8 weeks using the State Trait Anxiety Inventory (STAI-state). Secondary objectives aimed to demonstrate that Lpc-37 modulates psychological stress-induced symptoms and biomarkers related to mood and sleep. An exploratory analysis of fecal microbiota composition was also conducted. There was no difference between Lpc-37 and placebo groups in the change of STAI-state score (estimate 1.03; 95% confidence interval [CI]: -1.62, 3.67; p = 0.446). None of the secondary outcomes resulted in significant results when corrected for multiplicity, but exploratory results were notable. Results showed an improvement in sleep-disturbance scores (odds ratio 0.30; 95% CI: 0.11, 0.82; p = 0.020) and reduction in duration of sleep (odds ratio 3.52; 95% CI: 1.46, 8.54; p = 0.005) on the Pittsburgh Sleep Quality Index questionnaire after 8 weeks in the Lpc-37 group compared to placebo. A reduction in Bond Lader VAS-alertness was also demonstrated in the Lpc-37 group compared to placebo (estimate -3.97; 95% CI: -7.78, -0.15; p = 0.042) just prior to the examination. Analysis of fecal microbiota found no differences between study groups for alpha and beta diversity or microbiota abundance. Adverse events were similar between groups. Vital signs, safety-related laboratory measures, and gastrointestinal parameters were stable during the trial. In conclusion, probiotic Lpc-37 was safe but had no effect on stress, mood, or anxiety in healthy university students in this model of chronic academic stress. ClinicalTrials.gov: NCT04125810.

Project description:Bacterial vaginosis is one of the most common urogenital diseases affecting women in reproductive age. The administration of probiotics as vaginal suppository has been proposed as a strategy to cure this condition and reduce its recurrence. Nonetheless, also oral consumption of probiotics, which is a more practical route of administration, proved to be an efficient strategy. In this perspective, we studied Lactobacillus paracasei LPC-S01 (DSM 26760), a human vaginal isolate included in commercial probiotic preparations for topical use, in order to assess if this bacterium can also perform as gastrointestinal probiotic. Comparative genomics revealed the presence of several accessory genes suggesting that LPC-S01 is a niche-generalist member of its species. According to a procedure conventionally used to predict the probiotic potential, we demonstrated that the probiotic properties of strain LPC-S01, with respect to those of the well-known probiotic references L. paracasei Shirota and DG, are equal for the bile tolerance and the reduction of NF-?B activation in Caco-2 cells, or superior for the tolerance to gastric juice and the adhesion to Caco-2 epithelial cells. We then demonstrated that LPC-S01 is susceptible to antibiotics indicated by EFSA and does not produce biogenic amines. Finally, a double-blind cross-over pilot intervention trial on healthy human volunteers showed that, after a 7-days oral consumption of capsules containing about 24 billion live cells, the fecal cell concentrations of strains LPC-S01 and DG (evaluated by qPCR) were not dissimilar. Specifically, both probiotics' cell concentrations were above the detection limit for an average of 5 days from the end of the treatment, corresponding to a mean number of evacuations of 7 ± 2. Taken together, these data demonstrate that the vaginal isolate L. paracasei LPC-S01 possesses safety and functional properties that may support its use as probiotic to be administered per os for potential intestinal as well as vaginal applications.

Project description:BackgroundViral infections of the upper airways are the most common cause for absence from work or school, and there is evidence for probiotic efficacy in reducing the incidence and severity of these infections.ObjectivesWe aimed to confirm the previously reported beneficial effects of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2 against community-acquired common colds and identify a possible mechanism of action.MethodsIn a double-blind study, healthy adults (18-70 years of age) with at least 4 colds during the last 12 months before recruitment were randomly allocated to consume either probiotics (n = 448; total daily dose of 109 CFU with the 2 strains equally represented) or placebo (n = 450) once daily for 12 weeks. Recruitment took place from October to February during 2013-2016 (over 3 cold seasons). The probiotic impact on the severity of the colds (Wisconsin Upper Respiratory Symptom Survey-21) was the primary endpoint, whereas secondary endpoints included the incidence rate and duration of colds and an analysis of immune markers. Mann-Whitney U test and mixed model were used for the analysis of continuous variables and Fisher´s exact test was used for the analysis of categorical endpoints.ResultsSymptom severity was not reduced after intake of the probiotic, despite the positive trend seen in the first season. However, significantly fewer colds were experienced in the probiotic group (mean of 1.24 colds) as compared to the placebo group (mean of 1.36 colds; P = 0.044) for subjects reporting at least 1 cold, the incidence of recurring colds was 30% lower (20.8% vs. 29.8%, respectively; P = 0.055), and the use of analgesics was 18% lower (26.3% vs. 32%, respectively; P = 0.07). After 12 weeks, the change from baseline for IFN-γ differed between the groups (mean difference of -7.01; 95% CI, -14.9 to 0.93; P = 0.045).ConclusionsIntake of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2 can be protective against multiple colds in adults prone to getting colds.This trial was registered at clinicaltrials.gov as NCT02013934.

Dataset Information

Lacticaseibacillus paracasei Lpc-37® improves psychological and physiological markers of stress and anxiety in healthy adults: a randomized, double-blind, placebo-controlled and parallel clinical trial (the Sisu study).

Publications

<i>Lacticaseibacillus paracasei</i> Lpc-37® improves psychological and physiological markers of stress and anxiety in healthy adults: a randomized, double-blind, placebo-controlled and parallel clinical trial (the Sisu study).

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