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From the Townsend Letter
February / March 2018

The Vaginal Microbiota and Influence of Select Probiotic Lactobacilli Strains
by Anthony Thomas, PhD
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Fortified vs. Conventional Yogurt as Adjuvant Therapy for Bacterial Vaginosis
In another randomized, double-blind, placebo-controlled clinical trial, oral supplementation with the selected probiotic strains and yogurt significantly improved cure rate and symptoms of BV compared to control.66 Women with newly diagnosed BV (based on Amsel criteria, diagnostic criteria for BV of which 3 of 4 criteria must be met: pH > 4.5, positive whiff test, presence of discharge, and presence of clue cells in the wet smear) were administered metronidazole (2 x 500 mg/day) for one week and the multi-strain probiotic formulation twice daily in 125 g yogurt (intervention group; n = 17) or acidified yogurt (control group; n = 17), which naturally contained live fermentation starter cultures Lactobacillus delbrueckii subspecies bulgaricus and Streptococcus thermophilus.
     
After a four-week intervention period, 0/17 women had BV in the intervention group vs. 6/17 (35%) in the control group, a statistically significant and clinically relevant difference in cure rate. Amsel score was significantly decreased in the intervention group by a median value of 4 compared to a median value of only 2 in the control group. Odor and discharge (Amsel 2 and 3) was significantly decreased in the intervention group vs. control group, 2 vs. 1, respectively.

Immunosuppressed Pregnant Women and Obstetric Outcomes
The mother is the main source of microbes, both non-pathogenic and pathogenic, for newborn colonization. Dysbiotic vaginal microbiota characteristic of BV with marked reductions of lactobacilli increases risk of obstetric complications such as placental insufficiency, premature birth, fetal growth restriction, and postpartum endometritis,6,50,67,68 which is particularly relevant for women with immunosuppression and herpes virus infection (HVI).
     
The selected probiotic strains were evaluated for efficacy in the complex therapeutic and preventative intervention for pregnant women with HVI.69 Sixty pregnant women with HVI either received a patented food supplement to restore and support the vaginal microbiota twice daily for one week containing the selected probiotic strains and the prebiotic carbohydrate, fructooligosaccharides (intervention group; n = 30), or only prenatal care (comparator group; n = 30). Fifty healthy pregnant women without HVI were included as a control group. Intestinal lactobacilli and bifidobacteria were significantly increased in conjunction with significant decreases in pathogenic microbes (hemolytic E. coli, Klebsiella pneumoniae, Staphylococcus aureus, candida yeast species) in the intervention group vs. the comparison group, post-intervention levels which were similar to levels in healthy pregnant women of the control group. Prior to the intervention, 40% of women with HVI complained of symptoms associated with dysbiosis of the intestinal microbiota, namely bloating/abdominal discomfort, constipation, and mucus in the feces, but these complaints were reduced to only 12% of participants in the intervention group.
     
At the start of the study, vaginal lactobacilli were only detected in 13.3% and 16.7% of participants in the intervention and comparison groups, respectively, which was significantly increased in the intervention group to 46.7% after the one-week intervention, but not significantly different in the comparison group (20%). The percentage of women in the intervention group with a vaginal pH > 4.5, complaining of profuse vaginal discharge, swelling (hyperemia), and itching (pruritus), and with a positive amine test of vaginal discharge, were significantly decreased in the intervention group and no longer different than healthy pregnant women of the control group, whereas these parameters did not change in the comparison group.
     
The incidence of placental insufficiency and fetal distress were significantly reduced about two-fold in women of the intervention vs. comparison group. The percentage of aggravated pregnancy was significantly lower in women of the intervention group (33.3%) vs. the comparison group (53.3%). Furthermore, the percentage of women with other pregnancy complications (i.e., threatened miscarriage, threat of premature birth, pre-eclampsia, and pathology of amniotic fluid) was 25-50% fewer in the intervention vs. comparison group, which may be clinically relevant, but was not statistically significantly different in this study. This result was likely due to the small study population and variability and worth investigating in future, larger clinical trials.

Postmenopausal Women
Given the positive influence of estrogen on vaginal lactobacilli abundance, postmenopausal women experience a decrease in vaginal lactobacilli and increase in vaginal pH with increased incidence of UTIs due to increased colonization by enterobacteria. Clinical symptoms include vaginal dryness, burning, itching, dyspareunia, dysuria, urinary frequency, and recurrent UTIs.70,71
     
The genitourinary symptoms of meno-pause are particularly common in women with breast cancer due to chemotherapy and estrogen deprivation therapy. Vaginal estrogen therapy increases vaginal lactobacilli and decreases colonization by UPEC to reduce UTI recurrence,72 but estrogen treatment for women with breast cancer is used with restraint due to frequent estrogen sensitivity of the tumor.73 Thus, an appropriate probiotic intervention would be an alternative therapeutic option to enhance vaginal lactobacilli to discourage vaginal dysbiosis and recurrent UTIs.
     
Indeed, in a proof-of-principle pilot study,74 twice daily oral supplementation with the multi-strain probiotic formulation (2 X 2.5 billion live cells/dose) for two weeks in postmenopausal women with breast cancer receiving chemotherapy, with vaginal atrophy and an intermediate vaginal microbiota (Nugent score 4 - 6) (n = 11/group), improved the Nugent score (-1.3) towards a normal microbiota (< 3), whereas there was a deterioration in the control group receiving placebo (+0.45). One week post-discontinuation, the Nugent score regressed in those women previously receiving the probiotic intervention (to only -0.57 from baseline) and further deteriorated in the control group (+2.5 from baseline), suggesting the protective effect of the probiotic intervention is not sustained with discontinuation in this at-risk group.

True Probiotics
The application of true probiotics to support women's vaginal health (i.e., clinically validated dosing of probiotic formulations such as L. crispatus LbV 88 + L. jensenii LbV 116 + L. gasseri LbV 150N + L. rhamnosus LbV 96) in clinical practice has gained increasing recognition as a therapy and for prophylactic prevention. However, in a society that focuses on disease and drug therapy more so than natural preventative measures, significant efforts will be needed to get such probiotics into mainstream practice. The failure of most medical education programs to teach future physicians about the human microbiota, its relationship to health, and appropriate applications of specific, validated probiotic strains and multi-strain formulations, ultimately diminishes care for patients. It is critical that healthcare practitioners acknowledge the human microbiota and consider its role in health maintenance. Clinical research, dissemination of research results, and education will be key, as confusion about what constitutes a true probiotic-based intervention and misinforming marketing campaigns are widespread.

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References .pdf

Anthony Thomas, PhDAnthony Thomas, PhD, earned his bachelor's degree in nutrition, food science, and dietetics from California State University Northridge, his doctorate in nutritional biology from the University of California at Davis, and conducted postdoctoral research at the University of California at Los Angeles Larry Hillblom Islet Research Center. His primary research interests (via both pre-clinical and clinical studies) have focused on the influence of dietary and lifestyle factors (i.e., physical activity, circadian disruption) on the pathogenesis of chronic cardiovascular/metabolic diseases including obesity, insulin resistance syndrome, and type 2 diabetes. He has authored/co-authored multiple peer-reviewed scientific manuscripts and has served as a referee with relevant expertise in the fields of nutrition, obesity, and diabetes for multiple scientific journals.

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