Bacillus subtilis ZB423: 90-Day repeat dose oral (gavage) toxicity study in Wistar rats.

The novel genetically modified probiotic Bacillus subtilis ZB423 was assessed in a 90-day repeated-dose oral toxicity study adhering to Good Laboratory Practice (GLP) and Organization for Economic Cooperation and Development (OECD) guidelines. Spray-dried spores at a concentration of 1.1E12 CFU/g were administered at doses of 130, 260, and 519 mg/kg body weight/day correlating to 1.43 × 1011, 2.86 × 1011, and 5.71 × 1011 CFU/kg/day, respectively, by oral gavage to Wistar rats for a period of 90 consecutive days. Results showed no toxicologically relevant findings for B. subtilis ZB423 from measured parameters. The no observed adverse effect level (NOAEL) of B. subtilis ZB423 is 519 mg/kg body weight/day corresponding to 5.71 × 1011 CFU/kg/day for lyophilized B. subtilis ZB423 spores under the test conditions employed.

Clinical Prognostic Indicators in Predicting the Outcome in Patients with Bell's Palsy: A Descriptive, longitudinal Study from Puducherry, South India.

Electrophysiological studies can objectively predict the functional recovery in Bell's palsy but, the clinical prognostic indicators seem to be more practical where the nerve conduction studies are not available. To determine the clinical prognostic indicators in Bell's palsy patients and to determine the indicators with poor outcome for recovery. We designed a prospective, descriptive, and observational analysis of Bell's palsy patients, who presented to our ENT outpatients department. 34 patients with Bell's palsy were recruited for this study. We studied the demographic characteristics, sidedness, associated symptoms, time of presentation, grade, and therapeutic options. All the patients were followed up for 8 weeks and the final grade of functional recovery of the nerve was recorded. The patient information was entered in Epicollect 5software and the output was analysed as descriptive statistics. Hypothesis testing was accomplished by means of χ2 test or Fischer exact test, to compare the proportions of categorical data and continuous data using the Mann-Whitney U test. 91.17% (31/34) of Bell's palsy patients had complete facial nerve function recovery at the end of 8 weeks. Higher Age > 40 years (p = 0.022) and BP patients with coronary artery disease (p = 0.005) were the only two significant indicators for incomplete recovery. We suggest that all Bell's palsy patients seek medical advice early at the onset,especially the BP patients of older age and with coronary artery disease for faster recovery.