Effects of probiotic supplementation on hormonal and clinical outcomes of women diagnosed with polycystic ovary syndrome: A double-blind, randomized, placebo-controlled clinical trial

Abstract

• Recent studies have suggested a bidirectional association between intestinal microflora and pathological components of PCOS. • Probiotics and prebiotics are among the most studied functional foods used widely due to their beneficial role in reducing oxidative stress, inflammation, and insulin resistance. • The present study revealed that synbiotic supplementation in PCOS women for 12 weeks had a beneficial effect on SHBG but did not affect other clinical and hormonal parameters. Previous reports examined the efficacy of probiotic supplementation in women with polycystic ovary syndrome (PCOS); however, the main focus of these studies has been on metabolic and inflammatory parameters rather than hormonal indicators. Therefore, the current pilot study was carried out to examine the effects of probiotic supplementation on hormonal and clinical parameters of women diagnosed with PCOS. This study was conducted to investigate the effects of probiotic supplementation in women diagnosed with PCOS according to the 2003 Rotterdam criteria. Participants were randomized to either a probiotic (n = 50) or placebo (n = 49) group to receive allocated intervention for 12 weeks. Women’s hormonal profiles, including serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), sex hormone-binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), total testosterone (TT), and free androgen index (FAI) and clinical signs of PCOS including acne and hirsutism were examined at baseline and after 12 weeks of intervention. Analysis of covariance (ANCOVA) was done to assess between-group comparison in terms of probiotic efficacy. Following 12 weeks of intervention, compared with the placebo, probiotic supplementation significantly increased serum levels of sex hormone-binding globulin (SHBG) (+3.95; 95% CI: −6.20, 14.12 vs. −6.49; 95% CI: −12.71, −0.27; P = 0.030). However, no other significant improvement was observed in terms of hormonal and clinical outcomes. The present study revealed that probiotic supplementation in PCOS women for 12 weeks had a beneficial effect on SHBG but did not affect other clinical and hormonal parameters. Further RCTs with longer duration, other probiotic strains, other prebiotics, and higher dosages, respectively, may improve our knowledge regarding the role of gut microbiota in PCOS.