Effect of Probiotic supplementation on markers of inflammation and oxidative stress in Indian women with PCOS - a randomised open label clinical trial

Polycystic ovary syndrome (PCOS), the commonest endocrinopathy of reproductive age women manifests with a barrage of metabolic abnormalities including insulin resistance, glucose intolerance, CAD, metabolic syndrome, fatty liver etc. in addition to anovulation and hyperandrogenism. The prevalence of metabolic syndrome is as high as 33% in women with PCOS and has a long-term health consequence such as type 2 diabetes(T2DM), cardio vascular disease (CVD’s), sleep apnea, psychological problems, and cancers. Although the aetiology of PCOS is not completely understood yet, PCOS is considered a multifactorial disorder with various genetic, metabolic, endocrine and environmental factors. There is increasing evidence suggesting that PCOS affects the whole life of a woman, can begin in utero in genetically predisposed subjects, it manifests clinically at puberty, continues during the reproductive years. The multifactorial clinical spectrum of PCOS requires a multifaceted therapeutic approach.Lifestyle intervention, insulin sensitizers, and anti-androgens are the most common therapeutic approaches for the management of PCOS. However, their application depends on the individual clinical manifestations. Recently, modulation of intestinal microbiota equilibrium using probiotics have been suggested as an effective approach. The intestinal microbiota imbalance can lead to increased ovarian androgen production and prevents the spread of the natural follicles of the ovary through chronic inflammatory response and IR. The hypothesis that probiotics may be involved in maintenance of healthy gut microbiota, management of glycemic control, and can modulate inflammatory marker has received much attention. Recent meta analyses among patients with diabetes concluded that probiotics supplementation significantly decreased insulin resistance and HbA1c levels. Probiotics may improve the glycemic control through modulating reducing inflammatory cytokines and upregulation in the expression of peroxisome proliferator-activated receptor gamma gene. A meta-analysis in subjects with T2DM reported significant effects of probiotics biomarkers of inflammation and oxidative stress. However, probiotic supplementation among women with PCOS did not affect CRP levels. Probiotic may affect antioxidant status and hormonal profiles by alleviating insulin resistance and anti-inflammatory properties. Recently, it is stated that probiotic administration in animal models give better effects on metabolic responses and reproductive performance thorough additive actions. There is however scarce data investigating the impact of probiotic supplementation on oxidative stress levels in PCOS women. The present study is therefore designed to assess the effect of probiotic supplementation in combination with metformin on biomarkers of inflammation and oxidative stress in Indian women with PCOS.