Effects of synbiotic supplementation on the health-related quality of life in women with polycystic ovary syndrome. A randomized, triple-blind, placebo-controlled trial

Background: There are complicated mechanisms that link the disruption of the gut microbiome to the symptoms and complications of polycystic ovary syndrome (PCOS). In this study, an attempt was made to assess the effects of synbiotics on the health-related quality of life (HRQoL) in PCOS patients. Methods. Fifty-six women with PCOS were enrolled in a triple-blind controlled trial for 12 weeks. They were randomly assigned to receive a daily 2g synbiotic sachets (containing Bacillus coagulans (GBI-30), Lactobacillus rhamnus, Lactobacillus helveticus, and fructooligosaccharide) (n = 28) or placebo (n = 28). To evaluate the impact on the HRQoL, patients were required to fill 26-Item Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ-26), 12-Item Short-Form Health Survey (SF-12) and Perceived Stress Scale (PSS-10) pre and post the intervention. Results. Finally, statistical analyses were performed on 52 patients who finished the trial. Synbiotic supplementation improved the scores of emotional (P = 0.044), body hair (P = 0.016), weight (P = 0.033) and infertility domains (P = 0.027) of PCOSQ-26 compared to placebo group. The physical score within SF-12 also had a significant enhancement (P = 0.035). No significant improvement was seen in the PSS-10 score at the end of the trial. Conclusion. This study illustrated the advantageous effects of synbiotics on the health-related quality of life in PCOS patients. Further studies are required to confirm our findings. Trial registration: http://www.irct.ir : IRCT20211108053007N1; date of registration: 2023-02-14