Effectiveness of ORSL® Variants as an Adjuvant along with Standard-of-care Treatment in the Restoration of Oral Fluid, Electrolytes, and Energy in Patients with Fever and/or General Weakness in Indian Patients in an Outpatient Setting.

BACKGROUND: Dehydration due to reduced intake or increased losses including insensible losses in patients with acute nondiarrheal diseases may lead to fluid, electrolytes, and energy (FEE) deficits. The impact of oral FEE supplementation adjuvant to standard of care (SOC) treatment on recovery in patients with acute nondiarrheal diseases is yet to be evaluated. AIM: To determine the effectiveness of ORSL® variants (ORSL® Apple Drink and ORSL® PLUS Orange Drink), fruit juice-based electrolyte drinks as an adjuvant along with SOC in the restoration of oral FEE in patients with acute nondiarrheal disease with fever and/or general weakness who attended an outpatient department (OPD). MATERIALS AND METHODS: This was a prospective, interventional, open-label, multicenter, real-world, study conducted at eight sites across India. Patients with fever and/or general weakness due to an acute nondiarrheal illness were given either ORSL® Apple Drink or ORSL® PLUS Orange Drink as an adjuvant along with SOC treatment per physician's discretion. The primary endpoint of the study was to assess improvement from baseline in energy or hydration levels after ORSL® variants consumption at 6, 24, and 48 hours measured by a new aided recovery scale (ARS). Secondary endpoints were to assess the improvement in energy and hydration levels at 20, 40, and 60 minutes, as well as energy levels and hydration levels at 20, 40, and 60 minutes, 6, 24, and 48 hours after the consumption of ORSL® Apple Drink or ORSL® PLUS Orange Drink. The patient's consumption of ORSL® variants and treatment experience, physician's experience of recommending ORSL® variants, and product safety were evaluated. RESULTS: In total, 612 patients were enrolled with mean age 38.3 years, of whom 62.9% were male. The mean baseline level of energy and hydration was 1.59 (range 1.0-2.0) on ARS. Statistically significant (p < 0.0001) improvements were observed in energy or hydration 6 hours after first consumption of ORSL formulations. Furthermore, improvement was observed from 40 minutes, and in levels of energy, hydration, and both energy and hydration from 60 minutes. Patients and physicians reported a positive experience with ORSL® variants. CONCLUSION: ORSL® Apple Drink and ORSL® PLUS Orange Drink are clinically proven to provide hydration and/or energy to patients with fever and/or general weakness.

Quantitative analysis of the effects of essential oil mouthrinses on clinical plaque microbiome: a parallel-group, randomized trial.

BACKGROUND: The rich diversity of microorganisms in the oral cavity plays an important role in the maintenance of oral health and development of detrimental oral health conditions. Beyond commonly used qualitative microbiome metrics, such as relative proportions or diversity, both the species-level identification and quantification of bacteria are key to understanding clinical disease associations. This study reports the first-time application of an absolute quantitative microbiome analysis using spiked DNA standards and shotgun metagenome sequencing to assess the efficacy and safety of product intervention on dental plaque microbiome. METHODS: In this parallel-group, randomized clinical trial, essential oil mouthrinses, including LISTERINE® Cool Mint Antiseptic (LCM), an alcohol-containing prototype mouthrinse (ACPM), and an alcohol-free prototype mouthrinse (AFPM), were compared against a hydroalcohol control rinse on clinical parameters and the oral microbiome of subjects with moderate gingivitis. To enable a sensitive and clinically meaningful measure of bacterial abundances, species were categorized according to their associations with oral conditions based on published literature and quantified using known amounts of spiked DNA standards. RESULTS: Multivariate analysis showed that both LCM and ACPM shifted the dysbiotic microbiome composition of subjects with gingivitis to a healthier state after 4 weeks of twice-daily use, resembling the composition of subjects with clinically healthy oral conditions recruited for observational reference comparison at baseline. The essential oil-containing mouthrinses evaluated in this study showed statistically significant reductions in clinical gingivitis and plaque measurements when compared to the hydroalcohol control rinse after 6 weeks of use. CONCLUSIONS: By establishing a novel quantitative method for microbiome analysis, this study sheds light on the mechanisms of LCM mouthrinse efficacy on oral microbial ecology, demonstrating that repeated usage non-selectively resets a gingivitis-like oral microbiome toward that of a healthy oral cavity. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov on 10/06/2021. The registration number is NCT04921371.