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Breast (Edinburgh, Scotland) Oct 2023Abemaciclib-induced diarrhea (AID) impairs quality of life (QOL) and treatment adherence in patients with breast cancer. Supportive treatment with loperamide is... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Abemaciclib-induced diarrhea (AID) impairs quality of life (QOL) and treatment adherence in patients with breast cancer. Supportive treatment with loperamide is associated with constipation. We hypothesized that probiotics and trimebutine maleate (TM) would decrease the frequency of AID without causing constipation.
METHODS
Hormone receptor-positive, human epidermal growth factor 2-negative advanced breast cancer patients were randomized into the probiotic Bifidobacterium (A) or probiotic Bifidobacterium and TM (B) groups. Endocrine therapy, Abemaciclib and probiotic Bifidobacterium three times a day for 28 days, was administered to both arms. Arm B was treated with TM upon the onset of diarrhea. The primary endpoint was the percentage of patients who experienced grade ≥2 diarrhea. The secondary endpoints were safety, frequency, and duration of all-grade diarrhea; frequency of emesis and constipation; usage of loperamide; and health-related QOL/patient-reported outcome during the study. We evaluated whether the primary endpoint of each arm exceeded the predetermined threshold.
RESULTS
Fifty-one patients completed treatment. Grade 2 diarrhea occurred in 52% and 50% of patients in Arm A and Arm B, respectively. One patient experienced grade 3 diarrhea in each arm. The median duration of grade2 diarrhea was 2 and 2.5day, and only one patient required dose reduction. Grade ≥2 constipation was observed in 4% of Arm A and 3.6% of Arm B.
CONCLUSIONS
Probiotic Bifidobacterium or the combination of probiotic Bifidobacterium with TM did not decrease the incidence of grade 2 or greater diarrhea compared with historical control, although the grade 3 or greater diarrhea was reduced.
CLINICAL TRIAL REGISTRATION
jRCT (Japan registry of clinical trials). jRCTs031190154.
Topics: Humans; Female; Trimebutine; Quality of Life; Loperamide; Breast Neoplasms; Diarrhea; Probiotics; Constipation
PubMed: 37459790
DOI: 10.1016/j.breast.2023.07.003 -
NPJ Biofilms and Microbiomes Sep 2023Constipation and systemic inflammation are common in late pregnant and lactating sows, which cause health problems like uteritis, mastitis, dystocia, or even stillbirth,...
Constipation and systemic inflammation are common in late pregnant and lactating sows, which cause health problems like uteritis, mastitis, dystocia, or even stillbirth, further influencing piglets' survival and growth. Probiotic supplementation can improve such issues, but the beneficial mechanism of relieving constipation and enhancing gut motility remains underexplored. This study aimed to investigate the effects and mechanism of probiotic supplementation in drinking water to late pregnant sows on constipation, inflammation, and piglets' growth performance. Seventy-four sows were randomly allocated to probiotic (n = 36) and control (n = 38) groups. Probiotic treatment significantly relieved sow constipation, enhanced serum IL-4 and IL-10 levels while reducing serum IL-1β, IL-12p40, and TNF-α levels, and increased piglet daily gain and weaning weight. Furthermore, probiotic administration reshaped the sow gut bacteriome and phageome structure/diversity, accompanied by increases in some potentially beneficial bacteria. At 113 days of gestation, the probiotic group was enriched in several gut microbial bioactive metabolites, multiple carbohydrate-active enzymes that degrade pectin and starch, fecal butyrate and acetate, and some serum metabolites involved in vitamin and amino acid metabolism. Our integrated correlation network analysis revealed that the alleviation of constipation and inflammation was associated with changes in the sow gut bacteriome, phageome, bioactive metabolic potential, and metabolism.
Topics: Pregnancy; Animals; Female; Swine; Lactation; Inflammation; Butyrates; Constipation; Probiotics
PubMed: 37741814
DOI: 10.1038/s41522-023-00434-z -
JAMA Network Open Dec 2023Systematic reviews and meta-analyses often report conflicting results when assessing evidence for probiotic efficacy, partially because of the lack of understanding of... (Review)
Review
IMPORTANCE
Systematic reviews and meta-analyses often report conflicting results when assessing evidence for probiotic efficacy, partially because of the lack of understanding of the unique features of probiotic trials. As a consequence, clinical decisions on the use of probiotics have been confusing.
OBJECTIVE
To provide recommendations to improve the quality and consistency of systematic reviews with meta-analyses on probiotics, so evidence-based clinical decisions can be made with more clarity.
EVIDENCE REVIEW
For this consensus statement, an updated literature review was conducted (January 1, 2020, to June 30, 2022) to supplement a previously published 2018 literature search to identify areas where probiotic systematic reviews with meta-analyses might be improved. An expert panel of 21 scientists and physicians with experience on writing and reviewing probiotic reviews and meta-analyses was convened and used a modified Delphi method to develop recommendations for future probiotic reviews.
FINDINGS
A total of 206 systematic reviews with meta-analysis components on probiotics were screened and representative examples discussed to determine areas for improvement. The expert panel initially identified 36 items that were inconsistently reported or were considered important to consider in probiotic meta-analyses. Of these, a consensus was reached for 9 recommendations to improve the quality of future probiotic meta-analyses.
CONCLUSIONS AND RELEVANCE
In this study, the expert panel reached a consensus on 9 recommendations that should promote improved reporting of probiotic systematic reviews with meta-analyses and, thereby, assist in clinical decisions regarding the use of probiotics.
Topics: Humans; Consensus; Dietary Supplements; Probiotics; Systematic Reviews as Topic; Meta-Analysis as Topic
PubMed: 38064222
DOI: 10.1001/jamanetworkopen.2023.46872 -
World Journal of Gastroenterology Apr 2024Probiotics are live microorganisms exerting beneficial effects on the host's health when administered in adequate amounts. Among the most popular and adequately studied... (Review)
Review
Probiotics are live microorganisms exerting beneficial effects on the host's health when administered in adequate amounts. Among the most popular and adequately studied probiotics are bacteria from the families , and yeasts. Most of them have been shown, both and studies of intestinal inflammation models, to provide favorable results by means of improving the gut microbiota composition, promoting the wound healing process and shaping the immunological responses. Chronic intestinal conditions, such as inflammatory bowel diseases (IBD), are characterized by an imbalance in microbiota composition, with decreased diversity, and by relapsing and persisting inflammation, which may lead to mucosal damage. Although the results of the clinical studies investigating the effect of probiotics on patients with IBD are still controversial, it is without doubt that these microorganisms and their metabolites, now named postbiotics, have a positive influence on both the host's microbiota and the immune system, and ultimately alter the topical tissue microenvironment. This influence is achieved through three axes: (1) By displacement of potential pathogens competitive exclusion; (2) by offering protection to the host through the secretion of various defensive mediators; and (3) by supplying the host with essential nutrients. We will analyze and discuss almost all the and studies of the past 2 years dealing with the possible favorable effects of certain probiotic genus on gut immunological responses, highlighting which species are the most beneficial against intestinal inflammation.
Topics: Probiotics; Humans; Gastrointestinal Microbiome; Inflammatory Bowel Diseases; Animals; Intestinal Mucosa; Intestines; Dysbiosis
PubMed: 38681982
DOI: 10.3748/wjg.v30.i15.2096 -
Nutrients Jul 2023Emerging science shows that probiotic intake may impact stress and mental health. We investigated the effect of a 6-week intervention with (1 × 10 CFU/daily) on... (Randomized Controlled Trial)
Randomized Controlled Trial
Emerging science shows that probiotic intake may impact stress and mental health. We investigated the effect of a 6-week intervention with (1 × 10 CFU/daily) on stress-related psychological and physiological parameters in 45 healthy adults with mild-to-moderate stress using a randomized, placebo-controlled, two-arm, parallel, double-blind design. The main results showed that supplementation with the probiotic significantly reduced the perceived stress and improved the subjective sleep quality score compared to placebo. Comparing the two groups, momentary subjective assessments concomitant to the Maastricht Acute Stress Test revealed a lower amount of pain experience in the probiotic group and a higher amount of relief at the end of the procedure in the placebo group, reflected by higher scores in the positive affect state. The awakening of the salivary cortisol response was not affected by the intervention, yet the reduction observed in the salivary cortisol stress response post-intervention was higher in the placebo group than the probiotic group. Multivariate analysis further indicated that a reduction in perceived stress correlated with a reduction in anxiety, in depression, and in the cortisol awakening response after the 6-week intervention. This exploratory trial provides promising insights into to reduce perceived stress in a healthy population and supports the potential of nutritional solutions including probiotics to improve mental health.
Topics: Humans; Adult; Hydrocortisone; Bifidobacterium; Probiotics; Bifidobacterium longum; Stress, Psychological; Double-Blind Method
PubMed: 37513541
DOI: 10.3390/nu15143122 -
International Journal of Molecular... Jul 2023Alzheimer's disease (AD) is characterized by progressive cognitive decline and is a leading cause of death in the United States. Neuroinflammation has been implicated in...
Alzheimer's disease (AD) is characterized by progressive cognitive decline and is a leading cause of death in the United States. Neuroinflammation has been implicated in the progression of AD, and several recent studies suggest that peripheral immune dysfunction may influence the disease. Continuing evidence indicates that intestinal dysbiosis is an attribute of AD, and inflammatory bowel disease (IBD) has been shown to aggravate cognitive impairment. Previously, we separately demonstrated that an IBD-like condition exacerbates AD-related changes in the brains of the mouse model of AD, while probiotic intervention has an attenuating effect. In this study, we investigated the combination of a dietary probiotic and an IBD-like condition for effects on the brains of mice. Male C57BL/6 wild type (WT) and mice were randomly divided into four groups: vehicle control, oral probiotic, dextran sulfate sodium (DSS), and DSS given with probiotics. As anticipated, probiotic treatment attenuated the DSS-induced colitis disease activity index in WT and mice. Although probiotic feeding significantly attenuated the DSS-mediated increase in WT colonic lipocalin levels, it was less protective in the DSS-treated group. In parallel with the intestinal changes, combined probiotic and DSS treatment increased microglial, neutrophil elastase, and 5hmC immunoreactivity while decreasing c-Fos staining compared to DSS treatment alone in the brains of WT mice. Although less abundant, probiotic combined with DSS treatment demonstrated a few similar changes in brains with increased microglial and decreased c-Fos immunoreactivity in addition to a slight increase in Aβ plaque staining. Both probiotic and DSS treatment also altered the levels of several cytokines in WT and brains, with a unique increase in the levels of TNFα and IL-2 being observed in only mice following combined DSS and probiotic treatment. Our data indicate that, while dietary probiotic intervention provides protection against the colitis-like condition, it also influences numerous glial, cytokine, and neuronal changes in the brain that may regulate brain function and the progression of AD.
Topics: Mice; Male; Animals; Alzheimer Disease; Amyloid beta-Peptides; Mobile Applications; Mice, Inbred C57BL; Colitis; Inflammatory Bowel Diseases; Cytokines; Probiotics; Disease Models, Animal; Mice, Transgenic
PubMed: 37511312
DOI: 10.3390/ijms241411551 -
Microbiology (Reading, England) Dec 2023The bacterial family (the lactobacilli) occupy a unique role in microbiology due to their beneficial role in both human cultural history and biology, from the food...
The bacterial family (the lactobacilli) occupy a unique role in microbiology due to their beneficial role in both human cultural history and biology, from the food preservation of hunter gatherers-turned-farmers, through the prevention of scurvy in seafarers exploring new worlds, and the health-promoting properties of species that colonize the human body as well as animals that are important for agriculture and pollination. The almost bewildering phenotypic and genomic complexity of the former genus was recently reconciled with molecular taxonomy and phylogeny to establish robust genera comprising the , whose main features are summarized in this Microbe Profile.
Topics: Lactobacillaceae; Probiotics
PubMed: 38088348
DOI: 10.1099/mic.0.001414 -
Medicine Nov 2023Depression affects millions globally and often coexists with cognitive deficits. This study explored the potential of probiotics in enhancing cognition and ameliorating... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Depression affects millions globally and often coexists with cognitive deficits. This study explored the potential of probiotics in enhancing cognition and ameliorating depressive symptoms in major depressive disorder patients.
METHODS
Utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol and the Population, Intervention, Comparator, Outcome, and Study design framework, we systematically reviewed randomized controlled trials examining probiotic effects on cognition and depressive symptoms. Searches spanned 7 databases from January 2010 to May 2022. Risk of bias was assessed using Revised Cochrane Risk of Bias 2.0, and meta-analysis was conducted with RevMan 5.4.1. Publication bias was evaluated via Egger test.
RESULTS
In a systematic review on the effects of probiotic supplementation on cognition and depressive symptoms in depression patients, 635 records were initially identified, with 4 studies ultimately included. These randomized controlled trials were conducted across diverse regions, primarily involving females, with assessment periods ranging from 1 to 2 months. Concerning cognitive outcomes, a statistically significant moderate improvement was found with probiotic supplementation, based on the mean difference and its 95% confidence interval. However, for depressive symptoms, the overall effect was negligible and not statistically significant. A heterogeneity test indicated consistent findings across studies for both cognitive and depressive outcomes (I² = 0% for both). The potential for publication bias was evaluated using the Egger linear regression test, suggesting no significant bias, though caution is advised due to the limited number of studies.
CONCLUSION
Probiotics may enhance cognitive domains and mitigate depressive symptoms, emphasizing the gut-brain axis role. However, methodological variations and brief intervention durations call for more standardized, extensive research.
Topics: Female; Humans; Depressive Disorder, Major; Depression; Probiotics; Cognition; Research Design
PubMed: 38013351
DOI: 10.1097/MD.0000000000036005 -
Scientific Reports Oct 2023Multiple Sclerosis (MS) is a chronic demyelination disease of the central nervous system (CNS). The gut-brain axis involves communication between the nervous, endocrine,... (Randomized Controlled Trial)
Randomized Controlled Trial
Multiple Sclerosis (MS) is a chronic demyelination disease of the central nervous system (CNS). The gut-brain axis involves communication between the nervous, endocrine, and immune systems. Probiotics can positively impact immune and inflammatory responses by regulating gut microbiota. A total of 40 MS patients (average age of 34.38 ± 6.65) were examined to determine the effect of the Saccharomyces boulardii supplement for four months compared to a placebo. The results showed that the Saccharomyces boulardii significantly decreased the inflammatory marker high-sensitivity C-reactive protein (hs-CRP) compared to the placebo (P < 0.001). The serum antioxidant capacity (TAC) also increased significantly in the probiotic group compared to the placebo (p = 0.004). Both the probiotic and placebo groups showed a reduction in the oxidative stress indicator malondialdehyde (MDA), but there was no significant difference between the two groups. Pain intensity (measured by Visual Analogue Scale) and fatigue severity (measured by Fatigue Severity Scale) significantly decreased in the probiotic group compared to the placebo (p = 0.004 and p = 0.01, respectively). The probiotic group experienced significant improvement in some quality of life scales (measured by 36-Item Short Form Survey) and somatic and social dysfunction subscale of General Health Questionnaire scores compared to the placebo group (p = 0.01). The study suggests that the Saccharomyces boulardii probiotic supplement may benefit inflammatory markers, oxidative stress indicators, pain, fatigue, and quality of life in MS patients.
Topics: Humans; Adult; Multiple Sclerosis; Quality of Life; Probiotics; Dietary Supplements; Fatigue; Double-Blind Method
PubMed: 37903945
DOI: 10.1038/s41598-023-46047-6 -
Nutrients Jul 2023strains K7-Lb1, K8-Lb1 and K11-Lb3 were found to suppress Th1 and Th2 response and to enhance defensin release by enterocytes, respectively. Based on these... (Randomized Controlled Trial)
Randomized Controlled Trial
Effect of a Probiotic and a Synbiotic on Body Fat Mass, Body Weight and Traits of Metabolic Syndrome in Individuals with Abdominal Overweight: A Human, Double-Blind, Randomised, Controlled Clinical Study.
strains K7-Lb1, K8-Lb1 and K11-Lb3 were found to suppress Th1 and Th2 response and to enhance defensin release by enterocytes, respectively. Based on these anti-inflammatory actions, we investigated the effect of these strains on traits of metabolic syndrome, which is driven by low-grade inflammation. In a double-blind, randomised, placebo-controlled clinical trial with three parallel arms, 180 individuals with abdominal overweight were administered for 3 months with (1) placebo; (2) probiotic, comprising strains; or (3) synbiotic, comprising the strains + acacia gum (10 g daily). The effects were evaluated using Kruskal-Wallis one-way analysis of variance on ranks and post hoc tests (Holm-Sidak and Dunn's tests). The alteration (∆) in body fat mass (kg) (primary parameter) during intervention was significantly ( = 0.039) more pronounced in the Probiotic group (-0.61 ± 1.94; mean ± SD) compared with the Placebo group (+0.13 ± 1.64). Accordingly, differences were found in ∆ body weight ( = 0.012), BMI ( = 0.011), waist circumference ( = 0.03), waist-to-height ratio ( = 0.033), visceral adipose tissue (SAD) ( < 0.001) and liver steatosis grade (LSG) ( < 0.001), as assessed using sonography. In the Synbiotic group, ∆SAD ( = 0.002), ∆LSG ( < 0.001) and ∆constipation score ( = 0.009) were improved compared with Placebo. The probiotic mixture and the synbiotic improved the parameters associated with overweight.
Topics: Humans; Synbiotics; Metabolic Syndrome; Overweight; Probiotics; Double-Blind Method; Adipose Tissue
PubMed: 37447365
DOI: 10.3390/nu15133039