The effect of Lactiplantibacillus plantarum 299v together with a low dose of iron on iron status in healthy pregnant women: A randomized clinical trial.

INTRODUCTION: Iron deficiency during pregnancy is a global health problem and is associated with adverse pregnancy outcomes. The aim of this randomized, double-blind, placebo-controlled study was to evaluate the effect of Lactiplantibacillus plantarum 299v (Lp299v, 1010 colony forming units), 4.2 mg iron, 12 mg ascorbic acid and 30 µg folic acid (Lp) on iron status in healthy, non-anemic, pregnant Swedish women. MATERIAL AND METHODS: A total of 326 women were randomized to receive Lp (n = 161) or placebo (n = 165) twice daily from gestational week 10-12 until end of pregnancy or until the potential start of iron therapy. The primary endpoint was serum ferritin at week 28. RESULTS: Intake of Lp attenuated the decrease in serum ferritin from baseline to week 28 (p = 0.003) and week 35 (p Ë‚ 0.001) and resulted in reduced prevalence of iron deficiency (59% vs 78%, p = 0.017) and iron deficiency anemia (7.4% vs 21%, p = 0.023) at week 35. Intake of Lp also resulted in beneficial effects on the soluble transferrin receptor (p = 0.011) and total body iron (p Ë‚ 0.001) at week 35. Gestational length and birthweight were comparable between groups. The proportion of women reporting adverse events during the study was comparable between groups. CONCLUSIONS: Intake of Lp from early pregnancy was safe, attenuated the loss of iron stores and improved iron status in healthy pregnant women.

Evaluation of the efficacy of Lactobacillus plantarum HEAL9 and Lactobacillus paracasei 8700:2 on aspects of common cold infections in children attending day care: a randomised, double-blind, placebo-controlled clinical study.

BACKGROUND: The combination of Lactobacillus plantarum HEAL9 and Lactobacillus paracasei 8700:2 (commercially available as Probi Defendum®) has previously been reported to reduce the incidence, duration and severity of naturally acquired common colds in adults. The aim of the present study was to evaluate the impact of Probi Defendum® on aspects of common cold in healthy children 1-6 years of age attending day care. METHODS: A total of 131 children, out of the planned 320, were recruited into the study during 1 common cold season and randomised to consume once daily either 109 CFU (colony forming units) of the probiotic product or placebo. Due to unforeseen reasons, the recruitment of more children did not continue beyond the first cold season. RESULTS: There were 106 children that completed the study out of the 131 randomised. Daily consumption of the probiotic product for a period of 3 months significantly reduced the severity of the symptom "nasal congestion/runny nose" with a mean severity score for the whole study period of 7.5 ± 9.7 in the probiotic group and 13.9 ± 15.2 in the placebo (p < 0.05). Moreover, significantly less concomitant medication was used in the probiotic group. When the data were projected to a larger population corresponding to the originally estimated sample size, the results were in favour of the probiotic group regarding the reduced absence from day care (p < 0.05), reduced mean total severity per day in the reported episodes (p < 0.05) and reduced severity of the symptom "crying more than usual" (p < 0.05). CONCLUSION: Intake of Probi Defendum® once daily for a period of 3 months was beneficial to children and reduced the severity of common colds.

Correction to: Evaluation of the efficacy of Lactobacillus plantarum HEAL9 and Lactobacillus paracasei 8700:2 on aspects of common cold infections in children attending day care: a randomised, double-blind, placebo-controlled clinical study.

The original version of this article unfortunately contained a mistake. A number in Table 6 has been corrected.

Probiotic treatment using a mix of three Lactobacillus strains for lumbar spine bone loss in postmenopausal women: a randomised, double-blind, placebo-controlled, multicentre trial.

BACKGROUND: Postmenopausal bone loss in the spine is associated with an increased risk of vertebral fractures. Certain probiotic treatment protects rodents from ovariectomy-induced bone loss. The aim of the present study was to determine if treatment with a combination of three bacterial strains protects against the rapid spine bone loss occurring in healthy early postmenopausal women. METHODS: This randomised, double-blind, placebo-controlled, multicentre trial was done at four study centres in Sweden. Early postmenopausal women were randomly assigned in a 1:1 ratio to receive probiotic treatment consisting of three Lactobacillus strains (Lactobacillus paracasei DSM 13434, Lactobacillus plantarum DSM 15312, and Lactobacillus plantarum DSM 15313; 1 x 1010 colony-forming units per capsule) or placebo once daily for 12 months. The primary outcome was the percentage change from baseline in lumbar spine bone mineral density (LS-BMD) at 12 months. The primary analysis was done in all participants with BMD measurements available both at baseline and at 12 months. Analyses of adverse events and safety included all participants who had taken at least one capsule of placebo or Lactobacillus. This trial is registered with ClinicalTrials.gov, NCT02722980, and is completed. FINDINGS: Between April 18 and Nov 11, 2016, 249 participants were randomly assigned to receive probiotic product or placebo, and 234 (94%) completed the analyses required for the primary outcome. Lactobacillus treatment reduced the LS-BMD loss compared with placebo (mean difference 0·71%, 95% CI 0·06 to 1·35). The LS-BMD loss was significant in the placebo group (-0·72%, -1·22 to -0·22), whereas no bone loss was observed in the Lactobacillus-treated group (-0·01%, -0·50 to 0·48). The adverse events were similar between the two groups. INTERPRETATION: Probiotic treatment using a mix of three Lactobacillus strains protects against lumbar spine bone loss in healthy postmenopausal women. FUNDING: Probi.

A human ICAM-1 antibody isolated by a function-first approach has potent macrophage-dependent antimyeloma activity in vivo.

We isolated a tumor B-cell-targeting antibody, BI-505, from a highly diversified human phage-antibody library, using a pioneering "function-first" approach involving screening for (1) specificity for a tumor B cell surface receptor, (2) induction of tumor programmed cell death, and (3) enhanced in vivo antitumor activity compared to currently used treatments. BI-505 bound to intercellular adhesion molecule-1, identifying a previously unrecognized role for this receptor as a therapeutic target in cancer. The BI-505 epitope was strongly expressed on the surface of multiple myeloma cells from both newly diagnosed and relapsed patients. BI-505 had potent macrophage-dependent antimyeloma activity and conferred enhanced survival compared to currently used treatments in advanced experimental models of multiple myeloma.

Monoclonal antibody TB-403: a first-in-human, Phase I, double-blind, dose escalation study directed against placental growth factor in healthy male subjects.

BACKGROUND: TB-403 (RO5323441) is a humanized monoclonal antibody directed against placental growth factor (PlGF). Preclinical studies have demonstrated that targeting PlGF can result in significant inhibition of tumor growth and metastasis. OBJECTIVES: The purpose of this study was to assess the safety profile, tolerability, and pharmacokinetics of TB-403, developed for the treatment of solid tumors. METHODS: Healthy male subjects were exposed to a single intravenous infusion of TB-403 or placebo. Blood samples for hematology, clinical chemistry, coagulation factors, and urinalysis were collected; vital signs and ECGs were recorded; and serial blood samples were drawn for pharmacokinetic and immunogenicity measurements and circulating levels of pharmacodynamics markers PlGF and (VEGF) vascular endothelial growth factor. Sixteen subjects received either placebo or TB-403 at doses ranging from 0.3 to 5.0 mg/kg. RESULTS: Mild (grade 1 or 2) nasopharyngitis, headache, neck pain, and joint pain were the most frequently reported adverse events (AEs). There were no serious AEs in the study, and none of the AEs led to withdrawal. None of the safety laboratory assessments was considered clinically significant, and none was reported as an AE. There were no apparent differences in terms of safety profiles among the 3 dose levels of active treatment compared with placebo. Clearance, volume of distribution, and terminal t(½) (mean values) for TB-403 in all 3 cohorts were in the range of 4.2 to 4.9 (mL/d/kg), 56 to 79 (mL/kg), and 8 to 13 (days), respectively. CONCLUSION: The highest dose of TB-403 (5.0 mg/kg) was well tolerated in this study of a single intravenous infusion to healthy males. This result allowed a higher starting dose level in a subsequent Phase I study in cancer patients, the patient population for which this antibody is developed.