RESUMEN
IntroductionThe coronavirus disease 2019 (COVID-19) pandemic has been a major concern worldwide; however, easily accessible treatment options for patients with mild COVID-19 remains limited. Since oral intake of Lactococcus lactis strain Plasma (LC-Plasma) enhances both the innate and acquired immune systems through activation of plasmacytoid dendritic cells (pDCs), we hypothesized that the oral intake of LC-Plasma could aid the relief or prevention of symptoms in patients with asymptomatic or mild COVID-19. Methods and analysisThis is an exploratory, multicenter, double-blind, randomized, placebo-controlled trial. This study was initiated in December 2021 and concludes in April 2023. The planned number of enrolled subjects is 100 (50 patients x 2 groups); subject enrolment will be conducted until October 2022. Patients with asymptomatic or mild COVID-19 will be enrolled and randomly assigned in a 1:1 ratio to Group A (oral intake of LC-Plasma-containing capsule, 200 mg/day, for 14 days) or Group B (oral intake of placebo capsule, for 14 days). The primary endpoint is the change in subjective symptoms measured by the severity score. Secondary endpoints include SARS-CoV-2 viral loads, biomarkers for pDC activation, serum SARS-CoV-2-specific antibodies, serum cytokines, interferon and interferon-inducible antiviral effectors, and the proportion of subjects with emergency room visits to medical institutions or who are hospitalized. Ethics and disseminationThe study protocol was approved by the Clinical Research Review Board of Nagasaki University, in accordance with the Clinical Trials Act of Japan. The study will be conducted in accordance with the Declaration of Helsinki, Clinical Trials Act, and other current legal regulations in Japan. Written informed consent will be obtained from all participants. The results of this study will be reported in journal publications. RegistrationThis study was registered in the Japan Registry of Clinical Trials (registration number: jRCTs071210097). ARTICLE SUMMARYO_ST_ABSStrengths and limitations of this studyC_ST_ABSO_LIThis is the first randomized controlled trial to assess the efficacy of Lactococcus lactis strain Plasma (LC-Plasma) in preventing the onset and attenuation of symptoms in patients with asymptomatic or mild COVID-19. C_LIO_LIThis study is also the first to evaluate the significance of pDC-related immune responses, including interferon production, clearance of symptoms, and prevention of COVID-19 progression. C_LIO_LIThe results of this study may contribute to the development of novel treatment options for asymptomatic or mild COVID-19 patients. C_LIO_LIThis is an exploratory study, due to the lack of previous clinical evidence that evaluated the effect of LC-Plasma intake in patients with COVID-19. C_LIO_LIOther limitations include the subjective endpoint as the primary endpoint and generalizability, since this study will be conducted only in Japan in Japanese patients. C_LI
RESUMEN
BACKGROUND/AIMS: The fetus liver was characterized by its relatively larger left lobe than right lobe. So far there are no available morphometrical data and shape of the late-stage of human fetal liver, including identification of the intrahepatic vessels, which is little bit different from adult liver. METHODS: Among usual anatomic cadavers in department of anatomy of Sapporo medical university we choose normal- looking 12 late-stage human and 10 adult livers. At first, we measured the thickness and height and width of the livers at each designated sites and than underwent dissection for measurement of major intrahepatic vessels. In fetus, the upward protrusion of S8 was not evident, while S4 provided the greatest thickness of the liver. The fetus revealed an ellipsoid or oval shaped visceral surface and large S3, while the adult liver was triangular. The Arantius duct was almost always narrower than each of the 3 major hepatic veins, and it was often narrower than the umbilical vein. CONCLUSION: Both S2 and S6 seemed to enlarge during the postnatal growth, although there seemed to be great individual variations in the process of the growth. In the late stage fetus, three major hepatic veins seemed to play a great role for the venous return to the heart from the liver, rather then the Arantius duct.