With the growing popularity of probiotics in dietary supplements, foods, and beverages, it is important to substantiate not only the health benefits and efficacy of unique strains but also safety. In the interest of consumer safety and product transparency, strain identification should include whole-genome sequencing and safety assessment should include genotypic and phenotypic studies. Bacillus subtilis MB40, a unique strain marketed for use in dietary supplements, and food and beverage, was assessed for safety and tolerability across in silico, in vitro, and in vivo studies. MB40 was assessed for the absence of undesirable genetic elements encoding toxins and mobile antibiotic resistance. Tolerability was assessed in both rats and healthy human volunteers. In silico and in vitro testing confirmed the absence of enterotoxin and mobile antibiotic resistance genes of safety concern to humans. In rats, the no-observed-adverse-effect level (NOAEL) for MB40 after repeated oral administration for 14 days was determined to be 2000 mg/kg bw/day (equivalent to 3.7 × 1011 CFU/kg bw/day). In a 28 day human tolerability trial, 10 × 109 CFU/day of MB40 was well tolerated. Based on genome sequencing, strain characterization, screening for undesirable attributes and evidence of safety by appropriately designed safety evaluation studies in rats and humans, Bacillus subtilis MB40 does not pose any human health concerns under the conditions tested.
The CT findings in 16 patients with histologically proved primary central nervous system (CNS) reticulum cell sarcoma (RCS) showed this malignancy to have predilection for the basal ganglia and thalamus, the periventricular white matter, the corpus callosum, and the vermis cerebelli. In 43% of patients with untreated tumor it presented as multifocal lesions; in each of these patients the basal ganglia were involved in conjuction with another site. In the other 57% of patients with untreated tumor presenting as solitary lesions the basal ganglia, the corpus callosum, and the frontal lobe were sites of predilection. Such solitary lesions may be indistinguishable from other tumors. Contrast enhancement of RCS was characteristically homogeneous with rare lucency, even in very large lesions.
By 1 April 1973, 770 patients with malignancy were studied using Gallium‐67 (67Ga) citrate radioisotopic scanning at the Clinical Center, National Institutes of Health. Of these, 21 had brain tumors, 19 (90%) of which concentrated 67Ga. Forty‐four patients with melanoma had 54% of proven sites visualized on 67Ga scan (masses larger than 2 cm were detected in 75% of the sites). Ewing's sarcoma was studied in 15 patients with 67Ga scanning and all 15 primary tumors were visualized. Thirty‐two of 43 scans performed on 30 patients with acute leukemia were abnormal. Sites of leukemic involvement in bone marrow and as myeloblastomas in soft tissue contained high levels of 67Ga. Patients with untreated Hodgkin's disease were abnormal in 90% of cases on 67Ga scan with 70% of proven sites of involvement being detectable. Sixty percent of non‐Hodgkin's lymphoma sites were detected on 67Ga scans. Approximately 85% of anatomic sites involved with lung cancer were detected on scan. 67Ga citrate whole body scanning has proven to be useful in diagnosing and staging a wide variety of human tumors. The 67Ga study is most reliable when positive findings are recorded, but should be approached with caution when the findings are negative.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.