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NOT YET RECRUITING
NCT04836910

Microbiome and Polycystic Ovaries

Sponsor: Sheba Medical Center

View on ClinicalTrials.gov

Summary

Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS . Therefore, aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome.

Official title: The Change in Microbiome Following Treatment of Women With Polycystic Ovaries

Key Details

Gender

FEMALE

Age Range

18 Years - 42 Years

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-09-01

Completion Date

2027-03-30

Last Updated

2024-11-14

Healthy Volunteers

Not specified

Interventions

OTHER

Dietary recommendations

Fruit, vegetables, legumes (e.g. lentils and beans), nuts and whole grains (e.g. unprocessed maize, millet, oats, wheat and brown rice). At least 400 g (i.e. five portions) of fruit and vegetables per day excluding potatoes, sweet potatoes, cassava and other starchy roots. Less than 10% of total energy intake from free sugars Less than 30% of total energy intake from fats. Unsaturated fats (found in fish, avocado and nuts, and in sunflower, soybean, canola and olive oils) are preferable to saturated fats. Less than 5 g of salt (equivalent to about one teaspoon) per day.

DRUG

Oral contraceptive pills

Hormonal treatment

DRUG

Metformin

Insulin resistance treatment

Locations (1)

Sheba Medical Center

Ramat Gan, Israel