Six-month randomized, placebo controlled trial of synbiotic supplementation in women with polycystic ovary syndrome undergoing lifestyle modifications

Abstract

Purpose: To determine whether long-term administration of synbiotics affects clinical, endocrine and metabolic aspects of polycystic ovary syndrome (PCOS) in overweight and obese subjects undergoing intensive lifestyle modifications. Methods: During six-month trial, all subjects underwent intensive lifestyle modifications (diet and exercise). The subjects were randomized (1:1) to receive synbiotic supplementation (Synbiotic Group) or placebo (Placebo Group). Results: Subjects in the Placebo Group and the Synbiotic Group experienced significant reduction of BMI (− 8% and − 11%, respectively; both at P < 0.0001) and body fat percentage (− 11% and − 14%, respectively; both at P < 0.0001). These effects were statistically comparable for both groups. Total testosterone was not significantly changed in the Placebo Group (− 5%, P = 0.41) while it greatly declined in the Synbiotic Group (− 40%; P < 0.0001); the difference between these groups was significant (P = 0.0002). Synbiotic supplementation was superior to placebo in reducing LH (− 21%; P = 0.047), total cholesterol (− 6%; P = 0.002), low-density lipoprotein cholesterol (− 6%; P = 0.044), triglycerides (− 29%; P = 0.049), LPS (− 23%; P = 0.001) and LPS-binding protein (− 21%; P = 0.001). Conclusions: Synbiotic supplementation led to a marked improvement of several key clinical and laboratory aspects of PCOS including an improvement of hyperandrogenism, lipid profile, and markers of endotoxemia. Trial registration: Clinical Trial Registration Number: NCT03325023 (URL, clinicaltrials.gov; date of registration 10/26/2017).