MedTrace Logo

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

NCT03843736 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-10-10

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

BEHAVIORAL

Lifestyle intervention

1. Balance the diet; 2. Limit high-calorie and high-fat food intake, reduce eating out, and establish regular eating habits; 3. Monitor body weight, avoid sedentary, get more sun and regular activities; 4. Mental health regulation.

DRUG

Probiotic Agent

Patients have to take a probiotic powder (product name: Tangwen Tai, lactobacillus plantarum LP45 + Lactobacillus acidophilus La28 + Bifidobacterium lactobacillus BAL531) twice a day for three months.

DRUG

Oral contraceptive

The patient needs to take drospirenone ethinyl estradiol tablets (trade name: Yousi Yue) 1 tablet daily for 3 months.

Sponsors & Collaborators

  • Peking Union Medical College

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Rong Chen, Ph. D. · Beijing Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03843736 on ClinicalTrials.gov