Lower limb spasticity in post-stroke patients can impair ambulation and reduces activities of daily living (ADL) performance patients. Botulinum toxin type A (BoNTA) has been shown effective for upper spasticity. This study assesses the treatment lower a large placebo-controlled clinical trial. In this multicenter, randomized, double-blind, parallel-group, study, we evaluate efficacy safety one-time injections botulinum Japanese with One hundred twenty were randomized to single BoNTA 300 U...

Background Several biomarkers, including C-reactive protein (CRP), ferritin, D-dimer, and Interleukin-6 (IL-6), are established predictors of disease severity respiratory failure in patients with COVID-19. Objective In this randomised clinical study, we evaluated the efficiency combination 2 variants’ AFO-202 N-163 strains Aureobasidium pullulans produced 1,3-1,6 β-glucans comparison control arm on these biomarkers COVID-19 patients. Methods Forty RT-PCR positive were divided into groups: (n...

Objective:To evaluate the efficacy and safety of one-time injections botulinum toxin type A (BoNTA) in Japanese patients with post-stroke upper limb spasticity.Research design methods:In a multicentre, randomised, double-blind, parallel-group, placebo-controlled study, 109 spasticity were randomised to receive single treatment lower-dose (120–150 U) or higher-dose (200–240 BoNTA placebo into muscles.Clinical trial registration:NCT00460564Main outcome measures:The tone wrist flexor was...

Conventional vaccines to combat COVID-19 through different approaches are at various stages of development. The complexity such as the potential mutations virus leading antigenic drift and uncertainty on duration immunity induced by vaccine have hampered efforts control pandemic. Thus, we suggest an alternative interim treatment strategy based biological response modifier glucans Aureobasidium pullulans AFO-202-derived β-glucan, which has been reported induce trained immunity, akin that...

Background: Aureobasidium pullulans (black yeast) AFO-202 strain-produced beta glucan, Nichi Glucan, has been shown to improve the behavior and sleep pattern along with an increase in α-synuclein melatonin children autism spectrum disorder (ASD). Objective: In this randomized pilot clinical study, we have evaluated gut microbiota of subjects ASD after consumption Glucan. Methods: Eighteen were randomly allocated: six control group (Group 1): conventional treatment comprising remedial...

In this pilot clinical study, we report the beneficial effects of beta glucans derived from two strains AFO-202 and N-163 a black yeast Aureobasidium pullulans on biomarkers for cytokine storm coagulopathy in COVID-19 patients. A total 24 RT-PCR positive patients were recruited randomly divided into three groups (Gr): Gr. 1 control (n = 8) – Standard treatment; 2: treatment + glucan 8); 3, combination 30 days. There was no mortality or requirement ventilation subjects any groups. decrease...

<h3>Background</h3> Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are highly prevalent conditions characterized by inflammation fibrosis of the liver, which can progress to cirrhosis hepatocellular carcinoma if left untreated. Conventional modalities mainly symptomatic, with no definite solution. Beta-glucan-based biological response modifiers a potential strategy in lieu their beneficial metabolic effects. <i>Aureobasidium pullulans</i> strains AFO-202...

OBJECTIVES: In this pilot study, we have evaluated the specific metabolic and immune-related benefits of AFO-202 strain N-163 black yeast Aureobasidium pullulansproduced beta 1,3-1,6 glucan in healthy human subjects.METHODS: Sixteen Japanese male volunteers (aged 40 to 60 years) took part clinical trial.They were divided into four groups (n = 4 each): Group I consumed betaglucan (2 sachets 1 g each per day), IA for 35 days IB 21 days; II a combination each) beta-glucan (1 sachet 15 gel IIA...

The aim of the current study was to evaluate accuracy allometric scaling methods for drugs metabolized by UDP-glucuronosyltransferases (UGTs), such as ketoprofen, imipramine, lorazepam, levofloxacin, zidovudine, diclofenac, furosemide, raloxifene, gemfibrozil, mycophenolic acid, indomethacin, and telmisartan. Human plasma clearance (CL) predictions were conducted from preclinical in vivo data using multiple-species allometry with rule exponents single-species (SSS) mice, rats, monkeys, or...

Recent studies in laboratory rodents have revealed that circadian oscillation the physiologic functions affecting drug disposition underlies dosing time-dependent change pharmacokinetics. However, it is difficult to predict pharmacokinetics a diurnal human by using data collected from nocturnal rodents. In this study, we used cynomolgus monkeys, active animals, evaluate relevance of intestinal expression P-glycoprotein (P-gp) time dependency its substrates. The rhythmic phases gene...

Autism spectrum disorders (ASDs) are a wide range of behavioural disabilities for which there no definite interventional modalities available. Remedial therapies remain the only option but with varying outcomes. We have evaluated Childhood Rating Scale (CARS) and alpha-synuclein levels in this parallel-group, multiple-arm pilot clinical study after supplementation biological response modifier beta-glucan food supplement (Nichi Glucan).Six subjects ASD (n=6) Gr. 1 underwent conventional...

Objective The gut microbiome and its metabolites are influenced by age stress reflect the metabolism health of immune system. We assessed microbiota faecal metabolome in a static animal model non-alcoholic steatohepatitis (NASH). Design This was subjected to following treatments: reverse osmosis water, AFO-202, N-163, AFO-202+N-163 telmisartan treatment. Faecal samples were collected at 6 9 weeks age. analysed using 16S ribosomal RNA sequences acquired next-generation sequencing, gas...

This exploratory case-control study is to evaluate the effects of supplementation Aureobasidium pullulans-N-163 strain produced 1,3-1,- 6 beta glucan in young patients with Duchenne muscular dystrophy (DMD).Twenty-seven male subjects aged 5-19 years DMD were included, nine control arm and 18 treatment receive N-163 along conventional therapies for 45 days. While performing analysis, steroid usage was also taken into consideration, those not administered steroids (Steroid -ve) (Control, n =...

Abstract Duchenne muscular dystrophy (DMD) is a rare genetic disease, causing muscle degeneration due to lack of dystrophin with inadequate regeneration culminating in dysfunction. The N-163 strain Aureobasidium Pullulans produced Beta-1,3 − 1,6-glucan (Neu REFIX) reported be safe anti-inflammatory and anti-fibrotic efficacy earlier, herein we evaluated its effects on mdx mice. Forty-five mice three groups ( n = 15 each): Group 1 (normal), 2 control), 3 fed Neu were for 45 days. IGF-1,...

Dyslipidemia is a major risk factor for the development of cardiovascular diseases and statins are common drugs used to correct dyslipidemia. Herein, we report case where subject was nondiabetic, dyslipidemia patient on medication with Rosuvastatin. After intake Rosuvastatin, his triglycerides decreased minimum 220 mg/dL. In order augment action he advised take 1.5 mg Nichi Glucan food supplement, which 1,3-1,6 Beta derived from black yeast, Aureobasidium pullulans, daily 2 months. At end...

Abstract Background Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are highly prevalent conditions characterized by inflammation fibrosis of the which can progress to cirrhosis hepatocellular carcinoma if left untreated. Lifestyle disorders such as obesity, diabetes dyslipidaemia predispose associated with progression. Conventional modalities mainly symptomatic, no definite solution. Beta glucan-based biological response modifiers a potential strategy in...

Nuclear factor erythroid 2-related 2 (Nrf2) is a redox-sensitive transcription that binds to antioxidant response elements located in the promoter region of genes encoding many enzymes and phase II detoxifying enzymes. Activation Nrf2 pathway seems protective for organs, although well-known activator, bardoxolone methyl, was evaluated clinically treating chronic kidney disease, it found induce adverse events. Many methyl derivatives, mostly derived by chemical modifications, have already...

96 Background: Pancreatic cancer is a highly refractory tumor with poor prognosis, which aggressively progresses by suppressing the immunity. Surgical procedure related stress further weakens immunity and aids stem cell metastases, warranting immune enhancement strategies. AFO-202 strain of Aureobasidium Pullulans produced β-1,3-1,6 glucan (Nichi BRITE), having yielded in earlier studies, we evaluated its effects patients undergoing surgical resection malignant pancreatic tumors. Methods: 30...

The purpose of the present study was to harmonize protocol equilibrium solubility measurements for poorly water-soluble drugs lower inter-laboratory variance. “mandatory” and “recommended” procedures shake-flask method were harmonized based on knowledge experiences each company information from literature. model measured by (HP) non-harmonized proprietary (nonHP). Albendazole, griseofulvin, dipyridamole, glibenclamide used as drugs. When using nonHP, values showed large In contrast, variance...