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Ozone as adjuvant support in the treatment of COVID-19: A preliminary report of probiozovid trial.
Araimo, F, Imperiale, C, Tordiglione, P, Ceccarelli, G, Borrazzo, C, Alessandri, F, Santinelli, L, Innocenti, GP, Pinacchio, C, Mauro, V, et al
Journal of medical virology. 2021;(4):2210-2220
Abstract
The evaluation of new therapeutic resources against coronavirus disease 2019 (COVID-19) represents a priority in clinical research considering the minimal options currently available. To evaluate the adjuvant use of systemic oxygen-ozone administration in the early control of disease progression in patients with COVID-19 pneumonia. PROBIOZOVID is an ongoing, interventional, randomized, prospective, and double-arm trial enrolling patient with COVID-19 pneumonia. From a total of 85 patients screened, 28 were recruited. Patients were randomly divided into ozone-autohemotherapy group (14) and control group (14). The procedure consisted in a daily double-treatment with systemic Oxygen-ozone administration for 7 days. All patients were treated with ad interim best available therapy. The primary outcome was delta in the number of patients requiring orotracheal-intubation despite treatment. Secondary outcome was the difference of mortality between the two groups. Moreover, hematological parameters were compared before and after treatment. No differences in the characteristics between groups were observed at baseline. As a preliminary report we have observed that one patient for each group needed intubation and was transferred to ITU. No deaths were observed at 7-14 days of follow up. Thirty-day mortality was 8.3% for ozone group and 10% for controls. Ozone therapy did not significantly influence inflammation markers, hematology profile, and lymphocyte subpopulations of patients treated. Ozone therapy had an impact on the need for the ventilatory support, although did not reach statistical significance. Finally, no adverse events related to the use of ozone-autohemotherapy were reported. Preliminary results, although not showing statistically significant benefits of ozone on COVID-19, did not report any toxicity.
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Targeting Microbiome: An Alternative Strategy for Fighting SARS-CoV-2 Infection.
Spagnolello, O, Pinacchio, C, Santinelli, L, Vassalini, P, Innocenti, GP, De Girolamo, G, Fabris, S, Giovanetti, M, Angeletti, S, Russo, A, et al
Chemotherapy. 2021;(1-2):24-32
Abstract
Respiratory and gastrointestinal symptoms are the predominant clinical manifestations of the coronavirus disease 2019 (COVID-19). Infecting intestinal epithelial cells, the severe acute respiratory syndrome coronavirus-2 may impact on host's microbiota and gut inflammation. It is well established that an imbalanced intestinal microbiome can affect pulmonary function, modulating the host immune response ("gut-lung axis"). While effective vaccines and targeted drugs are being tested, alternative pathophysiology-based options to prevent and treat COVID-19 infection must be considered on top of the limited evidence-based therapy currently available. Addressing intestinal dysbiosis with a probiotic supplement may, therefore, be a sensible option to be evaluated, in addition to current best available medical treatments. Herein, we summed up pathophysiologic assumptions and current evidence regarding bacteriotherapy administration in preventing and treating COVID-19 pneumonia.
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Real word outcomes associated with use of raltegravir in older people living with HIV: results from the 60 months follow-up of the RAL-age cohort.
Santinelli, L, Ceccarelli, G, Borrazzo, C, Celani, L, Pavone, P, Innocenti, GP, Spagnolello, O, Fimiani, C, Ceci, F, Di Sora, F, et al
Expert review of anti-infective therapy. 2020;(5):485-492
Abstract
Objective: In people living with HIV (PLWH), antiretroviral treatments have increased the median life expectancy. Raltegravir (RAL) represents a long-term safe regimen used both in the first-line antiretroviral treatments and in the optimization strategies. Aim of the study was to evaluate the real-life efficacy, tolerability, and safety of the long-term RAL use in a multicenter cohort of elderly PLWH.Methods: A 60-month follow-up observational study was carried out in the RAL-AGE Cohort including aged PLWH (≥60 years old) treated with RAL-based regimens (n = 96). The control group was a cohort of PLWH aged less than 60 years (n = 50).Results: RAL treated aged HIV population experiences an increase of CD4+ cells and a stable control of viral load at 60 months of follow-up. A significant improvement in lipid metabolism profile, a decrease of platelet count and a reduction in cardiovascular risk levels were observed in the older population. Immune activation markers expressed on CD4+ T cells decreased compared to baseline, but this difference was greater in the control group.Conclusion: A 60-month treatment with RAL-containing regimens is safe and highly effective in the older PLWH and these data give new insights on the elderly population.Clinical trial registration: NCT02765776 and NCT03579485.
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Microbiome, Autoimmune Diseases and HIV Infection: Friends or Foes?
Pellicano, C, Leodori, G, Innocenti, GP, Gigante, A, Rosato, E
Nutrients. 2019;(11)
Abstract
Several studies highlighted the importance of the interaction between microbiota and the immune system in the development and maintenance of the homeostasis of the human organism. Dysbiosis is associated with proinflammatory and pathological state-like metabolic diseases, autoimmune diseases and HIV infection. In this review, we discuss the current understanding of the possible role of dysbiosis in triggering and/or exacerbating symptoms of autoimmune diseases and HIV infection. There are no data about the influence of the microbiome on the development of autoimmune diseases during HIV infection. We can hypothesize that untreated patients may be more susceptible to the development of autoimmune diseases, due to the presence of dysbiosis. Eubiosis, re-established by probiotic administration, can be used to reduce triggers for autoimmune diseases in untreated HIV patients, although clinical studies are needed to evaluate the role of the microbiome in autoimmune diseases in HIV patients.
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Short-Term Probiotic Administration Increases Fecal-Anti Candida Activity in Healthy Subjects.
De Angelis, M, Scagnolari, C, Oliva, A, Cavallari, EN, Celani, L, Santinelli, L, Innocenti, GP, Borrazzo, C, Ceccarelli, G, Vullo, V, et al
Microorganisms. 2019;(6)
Abstract
BACKGROUND Candida albicans' ability to evade host immune responses represents a serious threat for vulnerable patients. OBJECTIVES To investigate if (1) feces from healthy subjects exert anti-Candida activity; (2) fecal anti-Candida activity is modified by probiotic administration and (3) different probiotic differently modulate anti-Candida activity. PATIENTS AND METHODS Feces from healthy donors were analyzed before and after seven days of dietary supplementation with two different probiotic formulations (VSL#3®; Vivomixx®). Candida albicans was cultured with decreasing concentrations of diluted feces, obtained before and after the treatment period. The relationship between anti-Candida activity of feces, interferon-α, anti-interferon-α antibodies and the expression of MxA, ISG15 and IFNAR1 was also evaluated. RESULTS Feces obtained prior to probiotic intake and feces collected after supplementation with VSL#3® did not affect Candida albicans growth. On the contrary, a 3log10 inhibition of Candida development was observed after Vivomixx® intake. Interferon-α played a role in the inhibition of Candida growth. CONCLUSION Fecal anti-Candida activity was not observed prior to probiotic supplementation. Seven days of administration of Vivomixx® increased fecal anti-Candida activity, the same effect was not observed after intake of VSL#3®. The probiotic-induced anti-Candida activity seems to be related to an increased local production and release of interferon-α. Clinical trials are needed to determine if a short pretreatment with specific probiotic formulations may increase anti-Candida defenses in patients at risk.