Gynophilus® (Lcr regenerans®) is a live biotherapeutic product (LBP) that contains the live biotherapeutic microorganism Lactobacillus rhamnosus Lcr35®, which is indicated to restore vaginal health. The aim of the study was to compare the safety, ease of use, and compliance of two formulations (immediate release: IR capsule and slow release: SR muco-adhesive tablets) as well as the colonization of Lcr35® in healthy women. This phase I study (Comprigel) is a parallel, randomized, 4-arm, and open-label clinical trial evaluating an IR daily capsule formulation vs. a SR tablet administered every 3, 4, or 5 days for 21 days. Self-collected vaginal swabs were used to quantify Lcr35® and characterize the composition and structure of the vaginal microbiota. Both LBPs were well-tolerated, and no severe adverse effects were reported. All groups had Lcr35® vaginal concentrations over 107 colony forming unit per milliliter of vaginal secretion on each day in the study. The new Gynophilus® slow release tablets administered either every 3, 4, or 5 days provided vaginal concentrations that were not significantly different from those of classic Gynophilus® (capsule) once-a-day regimen. The LBPs and the different regimens did not adversely influence the abundance of native Lactobacillus spp. and indeed tended to favor their growth and reduce colonization by non-Lactobacillus spp. This study illustrates that the SR muco-adhesive LBP tablet (Gynophilus® SR) administered every 3 or 4 days as a safe, well-tolerated, and efficacious alternative to a more demanding IR daily capsule and could protect women’s healthy vaginal microbiome by promoting endogenous Lactobacillus spp.Electronic supplementary materialThe online version of this article (10.1007/s10096-018-3321-8) contains supplementary material, which is available to authorized users.
Two formulas of Lcr35 probiotic strain show very encouraging results for the treatment of IBS patients. Further studies are needed to better understand the role and mechanisms of probiotics on the pathogenesis of IBS.
Objective The aim of this study was to evaluate the effects of a lyophilized inactivated culture (LIC) from Bifidobacterium longum CBi0703 in a spontaneous model of osteoarthritis (OA) in Dunkin Hartley guinea pigs. Histology of cartilage and synovial membrane was the primary outcome. Biomarkers were also considered to evaluate the treatment efficacy. Design LIC (1 µg/kg) with or without vitamin C (1 mg/kg) were tested in Dunkin Hartley guinea pigs spontaneously developing OA and compared with control (sterile water; CTL). Treatment was initiated orally in 16-week-old animals over a period of 12 weeks. Histological lesions of articular cartilage and synovial membrane were scored according to the OARSI (Osteoarthritis Research Society International) recommendations. Four biomarkers (Coll2-1, PIINAP, Fib3-2, and osteocalcin) were measured in animal sera. Results The global OARSI score increased with time in all group but no significant difference between groups was observed. When score items were analyzed individually, a significant lower score of cartilage structure was observed in the LIC + vitamin C group compared with CTL ( P < 0.0001). Synovial membrane showed a mild inflammatory reaction that was not affected by the treatment. LIC significantly decreased serum levels of Coll2-1 ( P = 0.0004 vs. CTL), a marker of type II collagen degradation and LIC + vitamin C significantly increased PIINAP ( P = 0.0003), a marker of type II collagen synthesis. The ratio Coll2-1/PIINAP was significantly decreased in both LIC groups ( P < 0.001). Conclusion Lyophilized inactivated culture of B. longum CBi0703 administrated orally over a period of 12 weeks decreased cartilage structure lesions and decreased type II collagen degradation suggesting a potential prophylactic effect on OA development.
Figure 1. Lactate dehydrogenase (LDH) release 24 h post-treatment with LU (treated) or no treatment (control). The result suggests that viability of chondrocytes was not affected by LU exposure.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.