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

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ClinicalTrials.gov Identifier: NCT03843736
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Peking Union Medical College
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Behavioral: Lifestyle intervention Drug: Probiotic Agent Drug: Oral contraceptive Phase 3

  Show Detailed Description

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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

Resource links provided by the National Library of Medicine


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:
  • Drospirenone and Ethinylestradiol Tablets
  • Yousi Yue

Experimental: Probiotic Agent group
Participants are PCOS patients and will be given lifestyle interventions + Probiotic Agent 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: Oral contraceptive
The patient needs to take drospirenone ethinyl estradiol tablets (trade name: Yousi Yue) 1 tablet daily for 3 months.
Other Names:
  • Drospirenone and Ethinylestradiol Tablets
  • Yousi Yue

Experimental: Oral contraceptive group
Participants are PCOS patients and will be given lifestyle intervention + Oral contraceptive 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.
Other Name: Tangwen Tai




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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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
Criteria

Inclusion Criteria:

  1. Conforms to the 2003 Rotterdam classic PCOS diagnostic criteria.

    1. sparse ovulation or anovulation;
    2. clinical manifestations of high androgen and/or hyperandrogenism;
    3. 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;

  2. Age: 18-45 years old.

Exclusion Criteria:

  1. pregnancy;
  2. menopause;
  3. adrenal abnormalities;
  4. thyroid dysfunction;
  5. taking antibiotics for the past 3 months;
  6. is taking oral contraceptive treatment;
  7. basic diseases of the gastrointestinal tract (ulcerative colitis, Crohn's disease, inflammatory bowel disease, etc.);
  8. history of smoking;
  9. BMI<18kg/m2.

Information from the National Library of Medicine

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


Contacts
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Contact: Rong Chen, Ph. D. (86-10)-69155012 chenrongpumch@163.com
Contact: Xu Zhang, master zhangxu_5050@163.com

Locations
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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   
Sponsors and Collaborators
Peking Union Medical College Hospital
Peking Union Medical College
Investigators
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Study Director: Rong Chen, Ph. D. Beijing Union Medical College Hospital

Publications of Results:
Other Publications:
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03843736     History of Changes
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.

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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
Keywords provided by Peking Union Medical College Hospital:
Polycystic Ovary Syndrome
Metagenomics
Metabonomics
Additional relevant MeSH terms:
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Drospirenone
Ethinyl Estradiol
Polycystic Ovary Syndrome
Syndrome
Dysbiosis
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents