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1.
Effectiveness of Multistrain Probiotic Formulation on Common Infectious Disease Symptoms and Gut Microbiota Modulation in Flu-Vaccinated Healthy Elderly Subjects.
Sandionigi, A, De Giani, A, Tursi, F, Michelotti, A, Cestone, E, Giardina, S, Zampolli, J, Di Gennaro, P
BioMed research international. 2022;:3860896
Abstract
The decline of the immune system with aging leads elderly people to be more susceptible to infections, posing high risk for their health. Vaccination is thus important to cope with this risk, even though not always effective. As a strategy to improve protection, adjuvants are used in concomitance with vaccines, however, occasionally producing important side effects. The use of probiotics has been proposed as an alternative to adjuvants due to their efficacy in reducing the risk of common infections through the interactions with the immune system and the gut microbiota. A placebo-controlled, randomized, double-blind, clinical trial was carried out on fifty elderly subjects, vaccinated for influenza, to determine the efficacy of a probiotic mixture in reducing common infection symptoms. The incidence of symptoms was evaluated after 28 days of probiotic intake (namely, T28) and after further 28 days of follow-up (namely, T56). The number of subjects, as well as the number of days with symptoms, was remarkably reduced at T28, and even more at T56 in the probiotic group. Furthermore, the influence of probiotics on immunological parameters was investigated, showing a significant positive improvement of total antioxidant capacity and β-defensin2 levels. Finally, faecal samples collected from participants were used to assess variations in the gut microbiota composition during the study, showing that probiotic intake enhanced the presence of genera related to a healthy status. Therefore, the collected results suggested that the treatment with the selected probiotic mixture could help in reducing common infectious disease symptom incidence through the stimulation of the immune system, improving vaccine efficacy, and modulating the composition of the resident gut microbiota by enhancing beneficial genera.
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2.
Efficacy of a probiotic supplement in patients with atopic dermatitis: a randomized, double-blind, placebo-controlled clinical trial.
Michelotti, A, Cestone, E, De Ponti, I, Giardina, S, Pisati, M, Spartà, E, Tursi, F
European journal of dermatology : EJD. 2021;(2):225-232
Abstract
BACKGROUND Atopic dermatitis (AD) is a multifactorial long-standing inflammatory skin disease with a high incidence worldwide in both adults and children. According to the recognized correlation between skin and intestine-the so-called "gut-skin axis"-gut unbalances can affect skin by inducing systemic inflammation and triggering dermatological diseases such as AD. OBJECTIVES To evaluate the efficacy of a food supplement containing selected strains of probiotics in ameliorating AD symptoms and skin conditions in adult volunteers. MATERIALS & METHODS Eighty adult subjects showing mild-to-severe AD, skin dryness, desquamation, erythema and itching were enrolled in a randomized controlled trial to receive, for 56 days, a placebo or a mixture of lactobacilli (L. plantarum PBS067, L. reuteri PBS072 and L. rhamnosus LRH020). The latter was chosen according to the patients' production of post-biotic metabolites and B-group vitamins, anti-inflammatory and anti-oxidant capacity and anti-microbial activity. Clinical and instrumental dermatological evaluation was performed at T0d, T28d and T56d, and then at T84d (after a one-month wash-out). Inflammatory cytokine levels from skin tape stripping, sampled close to AD lesions at T0d and T56d, were also measured. RESULTS Subjects receiving the probiotic mixture showed an improvement in skin smoothness, skin moisturization, self-perception, and a decrease in SCORAD index as well as in the levels of inflammatory markers associated with AD at T28d, with a positive trend up to T56d which was maintained at T84d. CONCLUSION Administration of selected probiotic strains resulted in a fast and sustained improvement in AD-related symptoms and skin conditions.
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3.
Second-line Eribulin in Triple Negative Metastatic Breast Cancer patients. Multicentre Retrospective Study: The TETRIS Trial.
Krasniqi, E, Pizzuti, L, Valerio, MR, Capomolla, E, Botti, C, Sanguineti, G, Marchetti, P, Anselmi, E, Tomao, S, Giordano, A, et al
International journal of medical sciences. 2021;(10):2245-2250
Abstract
Introduction: Large and consistent evidence supports the use of eribulin mesylate in clinical practice in third or later line treatment of metastatic triple negative breast cancer (mTNBC). Conversely, there is paucity of data on eribulin efficacy in second line treatment. Methods: We investigated outcomes of 44 mTNBC patients treated from 2013 through 2019 with second line eribulin mesylate in a multicentre retrospective study involving 14 Italian oncologic centres. Results: Median age was 51 years, with 11.4% of these patients being metastatic at diagnosis. Median overall survival (OS) and progression free survival (PFS) from eribulin starting were 11.9 (95%CI: 8.4-15.5) and 3.5 months (95%CI: 1.7-5.3), respectively. We observed 8 (18.2%) partial responses and 10 (22.7%) patients had stable disease as best response. A longer PFS on previous first line treatment predicted a better OS (HR=0.87, 95%CI: 0.77-0.99, p= 0.038) and a longer PFS on eribulin treatment (HR=0.92, 95%CI: 0.85-0.98, p=0.018). Progression free survival to eribulin was also favorably influenced by prior adjuvant chemotherapy (HR=0.44, 95%CI: 0.22-0.88, p=0.02). Eribulin was generally well tolerated, with grade 3-4 adverse events being recorded in 15.9% of patients. Conclusions: The outcomes described for our cohort are consistent with those reported in the pivotal Study301 and subsequent observational studies. Further data from adequately-sized, ad hoc trials on eribulin use in second line for mTNBC are warranted to confirm our findings.
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4.
Eribulin in combination with bevacizumab as second-line treatment for HER2-negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI).
De Angelis, C, Bruzzese, D, Bernardo, A, Baldini, E, Leo, L, Fabi, A, Gamucci, T, De Placido, P, Poggio, F, Russo, S, et al
ESMO open. 2021;(2):100054
Abstract
BACKGROUND We evaluated the efficacy and safety of the nontaxane microtubule dynamics inhibitor eribulin plus the humanized anti-VEGF monoclonal antibody bevacizumab in a novel second-line chemotherapy scheme in HER2-negative metastatic breast cancer (MBC) patients progressing after first-line paclitaxel and bevacizumab. PATIENTS AND METHODS This is a multicenter, single-arm, Simon's two-stage, phase II study. The primary endpoint was the overall response rate, considered as the sum of partial and complete response based on the best overall response rate (BORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), and clinical benefit rate. RESULTS A total of 58 of the 61 patients enrolled in the study were evaluable for efficacy. The BORR was 24.6% (95% CI 14.5-37.3). The clinical benefit rate was 32.8% (95% CI 21.3-46.0). The median PFS was 6.2 months (95% CI 4.0-7.8), and median OS was 14.8 months (95% CI 12.6-22.8). Overall, adverse events (AEs) were clinically manageable and the most common AEs were fatigue, paresthesia, and neutropenia. Quality of life was well preserved in most patients. CONCLUSIONS The results of this study suggest that second-line therapy with bevacizumab in combination with eribulin has a meaningful clinical activity and may represent a potential therapeutic option for patients with HER2-negative MBC.
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5.
Exploratory analysis of circulating cytokines in patients with metastatic breast cancer treated with eribulin: the TRANSERI-GONO (Gruppo Oncologico del Nord Ovest) study.
Garrone, O, Michelotti, A, Paccagnella, M, Montemurro, F, Vandone, AM, Abbona, A, Geuna, E, Vanella, P, De Angelis, C, Lo Nigro, C, et al
ESMO open. 2020;(5):e000876
Abstract
BACKGROUND Anticancer drugs can interact with the tumour microenvironment and their effects could be exploited to favour anticancer immune response. Eribulin contributes to tumour vasculature remodelling and transforming growth factor β (TGF-β) modulation in experimental models and in humans. We performed a prospective, translational, exploratory analysis of the levels of circulating cytokines at different time points in patients with metastatic breast cancer treated with eribulin. METHODS TGF-β, tumour necrosis factor α, vascular endothelial growth factor, IL-6, IL-8, IL-10, IL-21 and C-C motif chemokine ligand-2 levels were assessed in peripheral blood samples obtained from seven healthy volunteers and 41 patients at baseline (T0), after four cycles of eribulin (T1) and at disease progression (TPD). Baseline values and longitudinal changes in cytokine levels were then related to clinical outcome. RESULTS In the 41 patients, high IL-6 and IL-8 (above the median) at T0 significantly correlated with worse survival. At T1, IL-21 significantly decreased in patients with TPD within the fourth course of treatment, compared with patients without progression. TGF-β and IL-8 above the median and IL-21 below the median at T1 significantly correlates with worse progression free survival (PFS). Patients exhibiting an increase of TGF-β or a decline of IL-21 between T0 and T1 showed a significantly worse PFS. Multivariate Cox regression analysis showed that only plasma TGF-β changes at T1 correlated with survival. At TPD, TGF-β significantly increased in all patients. CONCLUSIONS We observed a significant correlation between TGF-β decline during eribulin treatment and outcome in patients with metastatic breast cancer. Altogether, our data suggest that eribulin treatment might interfere with the tumour microenvironment.
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6.
Eribulin in the treatment of advanced breast cancer: real-world scenario from 39 Italian centers - ESEMPiO study.
Barni, S, Livraghi, L, Morritti, M, Vici, P, Michelotti, A, Cinieri, S, Fontanella, C, Porcu, L, Del Mastro, L, Puglisi, F, et al
Future oncology (London, England). 2019;(1):33-44
Abstract
AIM: We performed a multicenter retrospective cohort study of eribulin mesylate (EM) use in Italy, to describe the current practice for metastatic breast cancer patients (ESEMPiO) in the real-world. PATIENTS & METHODS Baseline characteristics, treatment administration and safety were summarized using descriptive statistics. RESULTS No safety concerns were raised in the population enrolled in the ESEMPiO database and treated in a real-life practice. Median progression-free survival and overall survival were 3.2 and 10.1 months, respectively. EM activity was similar between breast cancer subtypes. CONCLUSION In metastatic breast cancer patients treated with EM in 'real-world' setting, the clinician-registered outcomes were comparable to those reported in pivotal trials. Furthermore, EM maintained clinical activity and a tolerable safety profile.
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7.
Feasibility of Eribulin Mesylate in older patients with locally advanced or metastatic breast cancer: A post-hoc analysis of the ESEMPiO study.
Barni, S, Livraghi, L, Gravina, A, Martella, F, D'Onofrio, L, Morritti, M, Michelotti, A, Vici, P, Mentuccia, L, Porcu, L, et al
Journal of geriatric oncology. 2019;(6):990-993
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8.
Delayed-onset muscle soreness does not influence occlusal sensitivity and position sense of the mandible.
Bucci, R, Lobbezoo, F, Michelotti, A, Orfanou, C, Koutris, M
Journal of oral rehabilitation. 2017;(9):655-663
Abstract
Masticatory muscle-pain patients often complain about sensorimotor changes, but the effects of pain on the psychophysical properties remain unclear. This study aimed to investigate the effects of delayed-onset muscle soreness (DOMS) on the jaw's position sense (PS) and occlusal sensitivity (OS). In all, 12 participants underwent intense concentric-eccentric jaw exercises. Self-reported muscle fatigue and pain, pain-free maximum mouth opening (MMO), pain pressure thresholds (PPTs) at right and left masseter and right and left anterior temporalis, maximum voluntary bite force (MVBF), PS and OS were recorded before, immediately after, 24 h, 48 h and 1 week after the exercises. Data were analysed with repeated measures anova. Pain and fatigue increased significantly after the exercises, while fatigue also increased 24 h afterwards. Time and site had a significant effect for PPTs, not for MVBF. MMO decreased significantly 24 h after the exercises. OS and PS did not change significantly. Experimentally induced DOMS does not influence the psychophysical properties of the masticatory system.
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9.
A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation.
Mezzasalma, V, Manfrini, E, Ferri, E, Sandionigi, A, La Ferla, B, Schiano, I, Michelotti, A, Nobile, V, Labra, M, Di Gennaro, P
BioMed research international. 2016;2016:4740907
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A controlled balance between the healthy and harmful intestinal bacterial species is fundamental for maintaining a healthy gut. Recent studies have shown a correlation between microbiota imbalance and onset of IBS-related symptoms, however the available data remains limited and inconclusive. The aim of this trial was to assess the efficacy of multispecies probiotic supplementation on the gut microbiota of 150 patients diagnosed with IBS. Participants were randomly divided into three groups receiving either one of two probiotic mixtures or the placebo for 90 days. Stool samples were analysed and both symptom and quality of life questionnaires were recorded. The multispecies probiotic supplementation administered in this study demonstrated significant amelioration of IBS symptoms and improvement in quality of life. This supports the role of the gut microbiome in IBS and the potential role of multispecies probiotics in managing this disorder.
Abstract
Background and Aim. The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated. Methods. A randomized, double-blind, three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups (F_1, F_2, and F_3). Each group received a daily oral administration of probiotic mixtures (for 60 days) F_1 or F_2 or placebo F_3, respectively. Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics. Results. The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period (t60) and was maintained quite similar during the follow-up period (t90). Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3, and the same level was maintained during the follow-up period. Conclusions. Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota. This clinical study is registered with the clinical study registration number ISRCTN15032219.
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10.
Bioavailability Study of an Innovative Orobuccal Formulation of Glutathione.
Buonocore, D, Grosini, M, Giardina, S, Michelotti, A, Carrabetta, M, Seneci, A, Verri, M, Dossena, M, Marzatico, F
Oxidative medicine and cellular longevity. 2016;:3286365
Abstract
Alteration of the ubiquitous thiol tripeptide glutathione (GSH) is involved in oxidative stress, which plays a role in ageing; consequently, GSH is closely related to this process characterized by progressive decline in the efficiency of physiological function and increased susceptibility to disease. When circulating GSH decreases, oral administration might be considered a therapeutic benefit. Unfortunately, due to the hydrolysis of the tripeptide by intestinal γ-glutamyltransferase, dietary glutathione is not a major determinant for its increase. Aim of this work was to evaluate improvement of GSH systemic availability testing, in vitro and in vivo, an optimized orobuccal fast-slow release formulation tablet containing pure stabilized GSH. In vitro evaluation of the penetration capability of the innovative GSH-release formulation showed that GSH was well absorbed by the reconstructed oral epithelium and its absorption has features of time-dependence. In addition, in vivo results, obtained from 15 healthy volunteers, were in favor of GSH level improvement in blood showing fast (after 30 and 60 minutes) absorption through oral mucosa. In conclusion, the intake of GSH formulated through optimized orobuccal fast-slow release tablets gave positive results in raising GSH blood concentration.