The Role of Dysbiosis of Gut Microbiota in the Pathogenesis of PCOS.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03843736 |
Recruitment Status : Unknown
Verified October 2019 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : February 18, 2019
Last Update Posted : October 10, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome | Behavioral: Lifestyle intervention Drug: Probiotic Agent Drug: Oral contraceptive | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This study will collect 50 healthy participants and 150 PCOS participants. At the same time, 150 patients with PCOS will be randomly divided into the lifestyle intervention group, lifestyle interventions + Probiotic Agent group, lifestyle intervention + oral contraceptive group by random number table method. |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Role of Dysbiosis of Gut Microbiota in the Pathogenesis of Polycystic Ovary Syndrome. |
Actual Study Start Date : | February 21, 2019 |
Estimated Primary Completion Date : | June 30, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
---|---|
No Intervention: Health control group
Participants are healthy women and there are no interventions.
|
|
Experimental: Lifestyle interventions group
Participants are PCOS patients and only will be given lifestyle interventions.
|
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.
Other Name: Tangwen Tai Drug: Oral contraceptive The patient needs to take drospirenone ethinyl estradiol tablets (trade name: Yousi Yue) 1 tablet daily for 3 months.
Other Names:
|
Experimental: Probiotic Agent group
Participants are PCOS patients and will be given lifestyle interventions + Probiotic Agent interventions.
|
Behavioral: Lifestyle intervention
Drug: Oral contraceptive The patient needs to take drospirenone ethinyl estradiol tablets (trade name: Yousi Yue) 1 tablet daily for 3 months.
Other Names:
|
Experimental: Oral contraceptive group
Participants are PCOS patients and will be given lifestyle intervention + Oral contraceptive interventions.
|
Behavioral: Lifestyle intervention
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.
Other Name: Tangwen Tai |
- Diversity analysis of genes and species [ Time Frame: Through study completion, an average of 12 weeks ]Based on the gene and species composition of each sample, the Chao1 and Shannon indexes, as well as the observed OTUs (operational taxonomic units), will be calculated in order to identify the differences in gene and species diversity for each group.
- Analysis of differences in intestinal microbiota between PCOS patients and the control group [ Time Frame: Through study completion, an average of 12 weeks ]The Spearman correlation coefficient between genes will be calculated, and genes with strong correlation will be grouped into one cluster, as a CAG. The abundance of CAGs in each sample will be determined Furthermore, the significantly enriched species in the control and PCOS groups will be enumerated for network display.
- Analysis of functional differences in the intestinal microbiota of PCOS patients in comparison to the control group [ Time Frame: Through study completion, an average of 12 weeks ]The LEfSe discriminant analysis will be used to screen for significant differences between groups. The dimensionality reduction will be implemented by LDA, and the impact of function difference will be evaluated to obtain the LDA score and identify significantly different functions between groups.
- Correlation analysis between biomarkers and clinical indicators [ Time Frame: Through study completion, an average of 12 weeks ]For the obtained species, genes, or functions with significant difference, the correlation between them and clinical indicators will be calculated, and key biomarkers with significant and strong correlation will be identified.
- Insulin resistance [ Time Frame: Through study completion, an average of 12 weeks ]Use glucose tolerance and insulin test (75gOGTT+insulin) to assess whether the patient has insulin resistance, as well as the level of insulin resistance.
- Androgen level [ Time Frame: Through study completion, an average of 12 weeks ]Six-sex-hormone tests, one of the clinical examination items, will be performed to measure androgen levels in the subjects.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Polycystic ovary syndrome (PCOS) is a syndrome of endocrine disorders characterized by sparse ovulation or anovulation, high androgen or insulin resistance, and polycystic ovary. PCOS is a woman-specific disease, so participants must be women. |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
-
Conforms to the 2003 Rotterdam classic PCOS diagnostic criteria.
- sparse ovulation or anovulation;
- clinical manifestations of high androgen and/or hyperandrogenism;
-
ovarian polycystic changes: ultrasound suggests one or both sides of the ovary with a diameter of 2-9 mm follicles ≥ 12, and / or ovarian volume ≥ 10 ml;
2 out of 3 items, and exclude other high androgen causes, such as congenital adrenal hyperplasia, Cushing's syndrome, and androgen-secreting tumors;
- Age: 18-45 years old.
Exclusion Criteria:
- pregnancy;
- menopause;
- adrenal abnormalities;
- thyroid dysfunction;
- taking antibiotics for the past 3 months;
- is taking oral contraceptive treatment;
- basic diseases of the gastrointestinal tract (ulcerative colitis, Crohn's disease, inflammatory bowel disease, etc.);
- history of smoking;
- BMI<18kg/m2.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843736
Contact: Rong Chen, Ph. D. | (86-10)-69155012 | chenrongpumch@163.com | |
Contact: Xu Zhang, master | zhangxu_5050@163.com |
China | |
Peking Union Medical College Hospital | Recruiting |
Beijing, China | |
Contact: Rong Chen, Ph. D (86-10)-69155012 chenrongpumch@163.com | |
Contact: Xu Zhang, Master zhangxu_5050@163.com |
Study Director: | Rong Chen, Ph. D. | Beijing Union Medical College Hospital |
Other Publications:
Responsible Party: | Peking Union Medical College Hospital |
ClinicalTrials.gov Identifier: | NCT03843736 |
Other Study ID Numbers: |
JS-1691 81871141 ( Other Grant/Funding Number: National Natural Science Foundation of China ) |
First Posted: | February 18, 2019 Key Record Dates |
Last Update Posted: | October 10, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | According to national laws and regulations, human genetic resources may not be provided abroad. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Polycystic Ovary Syndrome Metagenomics Metabonomics |
Polycystic Ovary Syndrome Syndrome Dysbiosis Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Drospirenone Contraceptive Agents Ethinyl Estradiol |
Contraceptives, Oral Drospirenone and ethinyl estradiol combination Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Female Contraceptives, Oral, Hormonal Contraceptive Agents, Hormonal Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Mineralocorticoid Receptor Antagonists Hormone Antagonists Diuretics, Potassium Sparing Diuretics Natriuretic Agents |