Clinical trial · Interventional
The Role of Dysbiosis of Gut Microbiota in the Pathogenesis of PCOS.
The Role of Dysbiosis of Gut Microbiota in the Pathogenesis of Polycystic Ovary Syndrome.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifestyle intervention | Behavioral | — | UNRESOLVED |
| Oral contraceptive | Drug | — | UNRESOLVED |
| Probiotic Agent | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Health control group
- description
- Participants are healthy women and there are no interventions.
- type
- EXPERIMENTAL
- label
- Lifestyle interventions group
- description
- Participants are PCOS patients and only will be given lifestyle interventions.
- interventionNames
- Drug: Probiotic Agent
- Drug: Oral contraceptive
- type
- EXPERIMENTAL
- label
- Probiotic Agent group
- description
- Participants are PCOS patients and will be given lifestyle interventions + Probiotic Agent interventions.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.References
Publications (5)
- BACKGROUNDAlvarez-Blasco F, Luque-Ramirez M, Escobar-Morreale HF. Diet composition and physical activity in overweight and obese premenopausal women with or without polycystic ovary syndrome. Gynecol Endocrinol. 2011 Dec;27(12):978-81. doi: 10.3109/09513590.2011.579658. Epub 2011 May 24. PMID 21609197
- BACKGROUNDTremellen K, Pearce K. Dysbiosis of Gut Microbiota (DOGMA)--a novel theory for the development of Polycystic Ovarian Syndrome. Med Hypotheses. 2012 Jul;79(1):104-12. doi: 10.1016/j.mehy.2012.04.016. Epub 2012 Apr 27. PMID 22543078
- BACKGROUNDLiu R, Zhang C, Shi Y, Zhang F, Li L, Wang X, Ling Y, Fu H, Dong W, Shen J, Reeves A, Greenberg AS, Zhao L, Peng Y, Ding X. Dysbiosis of Gut Microbiota Associated with Clinical Parameters in Polycystic Ovary Syndrome. Front Microbiol. 2017 Feb 28;8:324. doi: 10.3389/fmicb.2017.00324. eCollection 2017. PMID 28293234
- RESULTGuo Y, Qi Y, Yang X, Zhao L, Wen S, Liu Y, Tang L. Association between Polycystic Ovary Syndrome and Gut Microbiota. PLoS One. 2016 Apr 19;11(4):e0153196. doi: 10.1371/journal.pone.0153196. eCollection 2016. PMID 27093642
- RESULTTorres PJ, Siakowska M, Banaszewska B, Pawelczyk L, Duleba AJ, Kelley ST, Thackray VG. Gut Microbial Diversity in Women With Polycystic Ovary Syndrome Correlates With Hyperandrogenism. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1502-1511. doi: 10.1210/jc.2017-02153. PMID 29370410