Beneficial immune-modulatory effects of the N-163 strain of Aureobasidium pullulans-produced 1,3-1,6 Beta glucans in Duchenne muscular dystrophy: Results of an open-label, prospective, exploratory case-control clinical study.

Background: This exploratory case-control study is to evaluate the effects of supplementation of Aureobasidium pullulans-N-163 strain produced 1,3-1,- 6 beta glucan in young patients with Duchenne muscular dystrophy (DMD). Methods: Twenty-seven male subjects aged 5-19 years with DMD were included, nine in the control arm and 18 in the treatment arm to receive N-163 beta glucan along with conventional therapies for 45 days. While performing the analysis, steroid usage was also taken into consideration, those not administered steroids (Steroid -ve) (Control, n = 5; treatment, n = 9), those administered steroids (Steroid +ve) (Control, n = 4; treatment, n = 9). Results: IL-6 showed a significant decrease in the treatment groups, especially the N-163 Steroid -ve group. IL-13 decreased in both treatment groups and TGF-ß levels showed a significant decrease in the treatment groups, especially the N-163 Steroid -ve group, (p < 0.05). Dystrophin levels increased by up to 32% in the treatment groups compared to the control. Medical research council (MRC) grading showed slight improvement in muscle strength improvement in 12 out of 18 patients (67%) in the treatment group and four out of nine (44%) subjects in the control group. Conclusion: Supplementation with the N-163 beta glucan food supplement produced beneficial effects: a significant decrease in inflammation and fibrosis markers, increase in serum dystrophin and slight improvement in muscle strength in DMD subjects over 45 days, thus making this a potential adjunct treatment for DMD after validation. Trial registration: The study was registered in Clinical trials registry of India, CTRI/2021/05/033346. Registered on 5th May, 2021.

ß­glucan vaccine adjuvant approach for cancer treatment through immune enhancement (B­VACCIEN) in specific immunocompromised populations (Review).

The incidence of cancer, which is the second leading cause of mortality globally, continues to increase, although continued efforts are being made to identify effective treatments with fewer side­effects. Previous studies have reported that chronic microinflammation, which occurs in diseases, including diabetes, along with weakened immune systems, may ultimately lead to cancer development. Chemotherapy, radiotherapy and surgery are the mainstream approaches to treatment; however, they all lead to immune system weakness, which in turn increases the metastatic spread. The aim of the present review was to provide evidence of a biological response modifier ß­glucan [ß­glucan vaccine adjuvant approach to treating cancer via immune enhancement (B­VACCIEN)] and its beneficial effects, including vaccine­adjuvant potential, balancing metabolic parameters (including blood glucose and lipid levels), increasing peripheral blood cell cytotoxicity against cancer and alleviating chemotherapy side effects in animal models. This suggests its value as a potential strategy to provide long­term prophylaxis in immunocompromised individuals or genetically prone to cancer.

Two unique biological response-modifier glucans beneficially regulating gut microbiota and faecal metabolome in a non-alcoholic steatohepatitis animal model, with potential applications in human health and disease.

OBJECTIVE: The gut microbiome and its metabolites are influenced by age and stress and reflect the metabolism and health of the immune system. We assessed the gut microbiota and faecal metabolome in a static animal model of non-alcoholic steatohepatitis (NASH). DESIGN: This model was subjected to the following treatments: reverse osmosis water, AFO-202, N-163, AFO-202+N-163 and telmisartan treatment. Faecal samples were collected at 6 and 9 weeks of age. The gut microbiome was analysed using 16S ribosomal RNA sequences acquired by next-generation sequencing, and the faecal metabolome was analysed using gas chromatography-mass spectrometry. RESULTS: Gut microbial diversity increased greatly in the AFO-202+N-163 group. Postintervention, the abundance of Firmicutes decreased, whereas that of Bacteroides increased and was the highest in the AFO-202+N-163 group. The decrease in the abundance of Enterobacteriaceae and other Firmicutes and the abundance of Turicibacter and Bilophila were the highest in the AFO-202 and N-163 groups, respectively. Lactobacillus abundance was highest in the AFO-202+N-163 group. The faecal metabolite spermidine, which is beneficial against inflammation and NASH, was significantly decreased (p=0.012) in the N-163 group. Succinic acid, which is beneficial in neurodevelopmental and neurodegenerative diseases, was increased in the AFO-202 group (p=0.06). The decrease in fructose was the highest in the N-163 group (p=0.0007). Isoleucine and Leucine decreased with statistical significance (p=0.004 and 0.012, respectively), and tryptophan also decreased (p=0.99), whereas ornithine, which is beneficial against chronic immune-metabolic-inflammatory pathologies, increased in the AFO-202+N-163 group. CONCLUSION: AFO-202 treatment in mice is beneficial against neurodevelopmental and neurodegenerative diseases, and has prophylactic potential against metabolic conditions. N-163 treatment exerts anti-inflammatory effects against organ fibrosis and neuroinflammation. In combination, these compounds exhibit anticancer activity.

Comparative analysis of detecting cervical lymph node metastasis with fine needle aspiration cytology.

OBJECTIVES: We correlated the results of cervical lymph node (LN) status by T-tumor size, N-nodal metastasis, M-distant metastasis (TNM) staging, and fine needle aspiration cytology (FNAC) in oral cancer patients to assess the discrepancy index (DI) between nodal metastasis (N) and FNAC results of cervicofacial LNs. MATERIALS AND METHODS: A total of 63 patients (29 females and 34 males) aged from 30 to 85 years were included in our study. Cervical LN status through TNM staging and FNAC results were matched and DI was calculated. RESULTS: DI in case of nodal status was 64.10% and 43.47% for TNMN1 and N2, respectively, indicating that tendency for observation of positive result on FNAC increased from N1 to N2. CONCLUSION: Hence, we suggest that relying solely on clinical examination and routine diagnostic tests like FNAC may not be appropriate and additional diagnostic imaging modalities should be considered.

Comparative Analysis of Linear and Angular Measurements on Digital Orthopantomogram with Calcaneus Bone Mineral Density.

BACKGROUND: Bone remodeling is a continuous and complex process which occurs throughout life. Radiomorphometric and radioangular indices on the orthopantomogram are the predictors of bone remodeling associated with mandible. Bone mineral density is the amount of calcified tissue in a certain volume of the bone. MATERIALS AND METHODS: Fifty normal healthy individuals within the age range of 25-55 years were included in the study. Linear measurements including mandibular cortical width (MCW) and panoramic mandibular index (PMI); and angular measurements including mandibular angle (MA) and antegonial angle (AGA) were recorded. Quantitative ultrasound bone mineral density (BMD) scan of the heel bone (calcaneus) of the same patient were also performed. RESULTS: In our study, for both males and females, antegonial angle (AGA) had highest correlation with calcaneus bone mineral density. In the age group of less than 35 years, PMI in males, and AGA in females had highest correlation. In the age range of more than 35 years, MA in males and AGA in females had highest correlation. CONCLUSION: There is a correlation between the mandibular bone remodelling changes and calcaneal bone mineral density in case of elder subjects and thus these parameters may be used as an inexpensive alternative screening method to assess the bone mineral density and identify individuals at risk for osteoporosis and fractures and also for dental treatment planning.