drugset / Trial / NCT03843736

The Role of Dysbiosis of Gut Microbiota in the Pathogenesis of PCOS.

NCT03843736

RandomizedParallel-groupSingle-blindTreatment

Summary

Polycystic ovary syndrome (PCOS) has a significant impact on women's health, but its pathogenesis is not yet clear. Dysbiosis of gut microbiota may play a role in the pathological change of PCOS. Most of the current researches are still limited to the use of amplicon sequencing to compare the basic taxonomic differences of gut microbiota between PCOS patients and normal controls. Overall analysis of microbiome species, genes, function, metabolism, and immunity in PCOS is still lacked. In this research, we would perform metagenomic sequencing to find the characteristics of gut microbiota of PCOS and to explore their correlations with metabolic, immune, and clinical symptoms. Finally, different interventions (lifestyle interventions, lifestyle interventions + oral probiotic, lifestyle interventions+ compound oral contraceptives) would be used to explore the change of gut microbiome in PCOS patients. This research will not only help the understanding of the pathophysiology of PCOS, but also provide a reference for the selection of clinical treatment options.

Timeline

Start
2019-02-21
Primary completion
2020-06-30
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Probiotic Agent Other / unclassified Oral
Subject drospirenone Unknown Oral
Subject ethinyl estradiol Small molecule