Effect of 12 weeks adjuvant probiotic supplementation on cardiovascular autonomic function in women with polycystic ovary syndrome - a randomized double-blind placebo-controlled trial

Registered patients from Obstetrics and Gynecology OPD JIPMER aged between 18 to 35 years will be recruited as per inclusion and exclusion criteria . After obtaining written consent ,the participants will be requested to reach the Department of Physiology after overnight fasting at around 8 am. Five ml of fasting blood sample will be collected to estimate metabolic and vascular markers. Demographic and clinical details will be collected. Anthropometric measurements and body composition analysis will be done. Following this cardiovascular autonomic function tests will be done. The baseline recording of the parameters for all the groups will be done during recruitment. The PCOS women allotted to groups 1 & 2 will be asked to continue their standard treatment along with probiotic or placebo therapy for 12 weeks. Women in group 1 will receive probiotic capsule [L. acidophilus, L.rhamnosus, L. reuteri (each 2 billion CFU); L. plantarum, L. casei, L. fermentum, Bifidobacterium bifidum (each 1 billion CFU) and fructo-oligosaccharides (100 mg)] once daily for 12 weeks. In addition to standard therapy while women in group 2 will be receiving placebo drug once daily along with standard therapy for 12 weeks. Placebo will be prepared using starch which will be made into capsules (maltodextrin) drug. While probiotic capsules will be purchased from GMP certified pharmaceutical company. Both capsules will be ensured to look alike to each other. All recruited women will be given add on drugs for a period of 12 weeks and follow up will be done. Drug adherence will be assessed by pill count method or through telecommunication . At the end of twelve weeks, the participants of both the groups will be asked to report to the department laboratory for the second recording (post-interventional) of the study parameters.