In women with recurrent BV after antibiotics, treatment with Lc IP 174178 administered over four menstrual cycles, could significantly reduce the rate of recurrence and increase the time to recurrence.
Vitamin D deficiency is frequent in the general population and both subjects and health professionals could benefit from a broader range of vitamin D3 formulations. We conducted a single-dose, open-label, parallel-group, randomized bioequivalence study to compare a single dose of a newly developed vitamin D3 100,000 IU in a soft capsule (Group 1) with the reference drug vitamin D3 100,000 IU oral solution in ampoule (Group 2) in healthy volunteers over a four-month period. The primary endpoint was the area under the curve (AUC) of serum 25-hydroxyvitamin-D (25(OH)D) concentrations on Day 112. This study was conducted in France from February to June 2014 in 53 young adults with a mean age of 26.9 years. At baseline, low mean serum 25(OH)D levels were observed in both groups (10.6 ng/mL in Group 1 and 9.0 ng/mL in Group 2). On Day 112, the AUC of serum 25(OH)D concentration was 2499.4 ± 463.8 nmol/mL (7.8 ± 0.2 for LogAUC) for Group 1 and 2152.3 ± 479.8 nmol/mL (7.6 ± 0.2 for LogAUC) for Group 2. Bioequivalence of the two treatments was not demonstrated. Superiority of vitamin D3 100,000 IU soft capsule was observed with p = 0.029 for AUC and p = 0.03 for LogAUC using a non-parametric Wilcoxon test. The profile of the serum 25(OH)D concentration showed a significant difference in favor of Group 1 on Days 1, 3, 7, 14 and 90. Mean serum 25(OH)D concentrations in Group 1 were between 20 and 30 ng/mL during the four-month period and under 20 ng/mL throughout the study in Group 2, except on Day 112. Mean Cmax for Group 1 was significantly higher (p = 0.002). Fourteen days were needed to reach Tmax by more than half the subjects in Group 1 compared to 45 days in Group 2. Both treatments were well tolerated, with no severe or related adverse events reported. In conclusion, the pharmacokinetic profile of the new formulation of vitamin D3 100,000 IU soft capsule is superior to that of the oral solution in ampoule. The new formulation increased serum 25(OH)D levels to above 20 ng/mL and maintained levels from 20 ng/mL to 30 ng/mL for four months in late winter and spring.
Background : Probiotics enhance human well-being. They can be used either as a preventive approach to maintain the microbiota or as an add-on treatment for some diseases. The lactobacilli constitute the predominant vaginal microorganism and have been associated with a beneficial effect in vaginal health by protecting and controlling the vaginal microbiota against bacterial vaginosis, vaginal candidiasis, and urinary tract infection. Results: We investigated the probiotic properties of the new vaginal Lactobacillus crispatus IP174178 strain isolated from healthy women. Lactobacillus crispatus IP174178 strain was identified by 16S rRNA sequencing and by biochemical characterization. L. crispatus IP174178 is Gram positive, Catalase negative, ADH negative, and an H 2 0 2 (5 mM) and lactic acid (D-lactate 6 g/l, L-lactate 3 g/l) producer, with a strong adherence capacity. Its sensitivity to antibiotics was evaluated. Conclusions: The native strain L. crispatus IP174178 showed natural antagonistic properties against vaginal pathogens ( Gardenerella vaginalis , Candida spp.) which is potentiated in its commercial live biotherapeutic product Physioflor ® . The L. crispatus IP174178 strain and its live biotherapeutic product Physioflor ® can thus be considered a good probiotic candidate for the prevention of vaginal infections.
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