Fewer Community-Acquired Colds with Daily Consumption of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2. A Randomized, Placebo-Controlled Clinical Trial.

BACKGROUND: Viral infections of the upper airways are the most common cause for absence from work or school, and there is evidence for probiotic efficacy in reducing the incidence and severity of these infections. OBJECTIVES: We aimed to confirm the previously reported beneficial effects of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2 against community-acquired common colds and identify a possible mechanism of action. METHODS: In a double-blind study, healthy adults (18-70 years of age) with at least 4 colds during the last 12 months before recruitment were randomly allocated to consume either probiotics (n = 448; total daily dose of 109 CFU with the 2 strains equally represented) or placebo (n = 450) once daily for 12 weeks. Recruitment took place from October to February during 2013-2016 (over 3 cold seasons). The probiotic impact on the severity of the colds (Wisconsin Upper Respiratory Symptom Survey-21) was the primary endpoint, whereas secondary endpoints included the incidence rate and duration of colds and an analysis of immune markers. Mann-Whitney U test and mixed model were used for the analysis of continuous variables and Fisher´s exact test was used for the analysis of categorical endpoints. RESULTS: Symptom severity was not reduced after intake of the probiotic, despite the positive trend seen in the first season. However, significantly fewer colds were experienced in the probiotic group (mean of 1.24 colds) as compared to the placebo group (mean of 1.36 colds; P = 0.044) for subjects reporting at least 1 cold, the incidence of recurring colds was 30% lower (20.8% vs. 29.8%, respectively; P = 0.055), and the use of analgesics was 18% lower (26.3% vs. 32%, respectively; P = 0.07). After 12 weeks, the change from baseline for IFN-γ differed between the groups (mean difference of -7.01; 95% CI, -14.9 to 0.93; P = 0.045). CONCLUSIONS: Intake of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2 can be protective against multiple colds in adults prone to getting colds.This trial was registered at clinicaltrials.gov as NCT02013934.

A Phase I Dose-Escalation Study of Antibody BI-505 in Relapsed/Refractory Multiple Myeloma.

PURPOSE: This multicenter, first-in-human study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of BI-505, a human anti-ICAM-1 monoclonal antibody, in advanced relapsed/refractory multiple myeloma patients. EXPERIMENTAL DESIGN: BI-505 was given intravenously, every 2 weeks, at escalating doses from 0.0004 to 20 mg/kg, with extension of therapy until disease progression for responding or stable patients receiving 0.09 mg/kg or higher doses. RESULTS: A total of 35 patients were enrolled. The most common adverse events were fatigue, pyrexia, headache, and nausea. Adverse events were generally mild to moderate, and those attributed to study medication were mostly limited to the first dose and manageable with premedication and slower infusion. No maximum tolerated dose was identified. BI-505's half-life increased with dose while clearance decreased, suggesting target-mediated clearance. The ICAM-1 epitopes on patient bone marrow myeloma were completely saturated at 10 mg/kg doses. Using the International Myeloma Working Group criteria, 7 patients on extended therapy had stable disease for more than 2 months. CONCLUSIONS: BI-505 can be safely administered at doses that saturate myeloma cell ICAM-1 receptors in patients. This study was registered at www.clinicaltrials.gov (NCT01025206).