Effects of supplementation with two probiotic strains on metabolic profile, hormonal status, oxidative stress, and quality of life in women with polycystic ovary syndrome: A study protocol for a randomized clinical trial

Abstract

Background: Polycystic ovarian syndrome (PCOS) is a common endocrine disorder in women, associated with insulin resistance, ovulatory dysfunction, hyperandrogenism, and inflammation. Current treatments often focus on symptoms rather than underlying causes, emphasizing the need for comprehensive strategies. Recently, probiotics have emerged as a safe and cost-effective nutritional option for managing metabolic issues. Objective: This study aims to evaluate the effects of Lactobacillus helveticus and Bifidobacterium longum supplementation on the cardiometabolic profile, hormonal status, oxidative stress, and quality of life in women with PCOS. Materials and Methods: We will conduct a double-blind, placebo-controlled, randomized trial involving 90 women with PCOS from Shahid Beheshti hospital, Isfahan, Iran. Recruitment will begin on June 20, 2024, and is expected to be completed by June 20, 2025. Participants will be randomly assigned to receive either a daily probiotic capsule containing Lactobacillus helveticus and Bifidobacterium longum or a placebo. The study will assess the impact of these probiotic strains on cardiometabolic profile, hormonal status, oxidative stress, mental health, quality of life, sleep quality, and clinical symptoms in women with PCOS. All parameters will be evaluated before and after the intervention. Discussion: Elevated insulin levels and gut microbiota imbalances significantly contribute to the development of PCOS. Growing evidence suggests that gut dysbiosis is linked to sex hormone levels and estrous cycles. We hypothesize that probiotic supplementation in individuals with PCOS will improve hormonal, metabolic, inflammatory, and antioxidant markers compared to those receiving a placebo.