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Clinical Trial Summary

The aim of the present study is to evaluate the effect of the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels.


Clinical Trial Description

Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy in women, affecting 4-15% of those who are of childbearing age. It is a complex and heterogeneous disease in which the gynecological disorder coexist with metabolic problems such as insulin resistance.

The beneficial effect of the extract plant BSL-EP044 on glycemic metabolism in women with PCOS is widely studied and demonstrated and Lactobacillus BSL_PS6 appears to exert a synergistic effect by supplementing the effect of BSL-EP044. The hypothesis of our study is that the addition of the probiotic strain Lactobacillus BSL_PS6 to extract plant BSL-EP044 treatment may improve the beneficial effect of this one on insulin resistance and other metabolic alterations related to PCOS.

The main objective of the present study is to evaluate the effect of the combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters related to glycemic metabolism in women with polycystic ovary syndrome and high insulin levels. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04029805
Study type Interventional
Source Biosearch S.A.
Contact Juristo Fonollá, PhD
Phone +34958240288
Email Juristo.FonollaJoya@biosearchlife.com
Status Recruiting
Phase Phase 1/Phase 2
Start date May 29, 2019
Completion date August 30, 2020

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