Investigating the effect of suuplementation with two probiotic strains (Lactobacillus helveticus, Bifidobacterium longum) on cardiometabolic profile, hormonal status, oxidative stress and quality of life in women with polycystic ovary syndrome: a randomized double-blind controlled clinical trial.

Determining the effect of two probiotic strains supplementation (Lactobacillus heloticus, Bifidobacterium longum) on cardiometabolic profile, hormonal status, oxidative stress and quality of life in women with polycystic ovary syndrome.

A double-blind randomized controlled clinical trial with parallel groups, phase 3, on 90 women suffering from polycystic ovary syndrome. For randomization, the stratified block randomization method will be used.

Eligible people will be selected with the approval of a gynecologist and will enter the study with full consent. The duration of supplemental is 8 weeks. blood samples will be taken from all patients to determine and compare the effect of probiotic supplements or placebo on biochemical indicators. For the purpose of blinding, the drug and placebo are prepared and coded in completely similar containers without name labels, in the same color and smell, and are given to people based on random allocation by the project partner.

Inclusion criteria: Patients with polycystic ovary syndrome who agree to participate in the study. Exclusion criteria: Pregnancy and breastfeeding, Taking supplements or probiotic products during the last four weeks, Suffering from mental illnesses , Hyperprolactinemia, Menopause, Uncontrolled diabetes, Suffering from chronic diseases

The subjects of the intervention group, will recieve one probiotic capsule daily (containing two strains of Lactobacillus heloticus with a dose of 3 billion clonies and Bifidobacterium longum with a dose of 3 billion clonies) and the placebo group will recieve one placebo capsule daily (maltodextrin with a dose of 300 mg).

FBS, Lipid profile, CRP, MDA, TAC, SOD, Fasting Insulin, Total testosterone, SHBG, DASS, Quality of life, sleep quality and hirsutism

The participants will randomly (using stratified block randomization method ) be assigned to one of the two groups receiving probiotic supplements or the group receiving probiotics placebo, as a control group. In order to distribute patients into intervention and control groups, first, people will be classified according to their body mass index (less than 25 and 25 or more) and divided using blocks of four. Due to the existence of an intervention and control group, six blocks of 4 have been considered and in order to distribute people into two groups, one of these blocks will be randomly selected. In other words, people with the same conditions in terms of body mass index will be distributed in intervention and control groups using each of the mentioned blocks. Dice will be used to choose one of the 6 blocks of four. People in the intervention group will receive a daily probiotic capsule (containing two strains of Lactobacillus heloticus and Bifidobacterium longum, a product of Parsi Locket Shiraz Company) and the placebo group will also receive a placebo capsule (maltodextrin, a product of Parsi Locket Shiraz Company).

The study will be conducted in a double-blind manner as follows: The drug and placebo are provided to all groups in completely similar containers without name labels, prepared in the same color and smell and coded based on random allocation by the design partner. Therefore, none of the patients were aware of the assigned treatment and will not be informed until the end of the study. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed. In order to follow up that the participants in two groups use the capsules, these people will be contacted weekly by phone or SMS and the consumption of the capsules will be reminded. Also, for further follow-up, in addition to phone calls, patients are asked to return the used supplement can at the end of each month to determine the number of remaining and unused capsules, and finally, the percentage of patient compliance is calculated through the pill count method formula. to be People who have less than 90% adherence to supplements are also excluded from the study.