Microbiome and Polycystic Ovaries
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-42
SponsorSheba Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Endocrine abnormality ( Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorder, hyperprolactinemia and androgen-secreting tumor).
Premature ovarian failure 2. Active malignancy 3. Participants taking antibiotics/ probiotics, hormonal, vaginal or laxative medicine (in the previous week).
Trial population
Study group will include 20 women in fertility age (age 18-42) diagnosed with PCOS according to the Rotterdam Criteria who haven't started any treatment. The control group would include healthy women matched by age.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Dietary recommendations
Other interventionFruit, 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.
Oral contraceptive pills
DrugHormonal treatment
Metformin
DrugInsulin resistance treatment
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Study Group: Women with Polycystic Ovary Syndrome3 interventions
Group B: Cohort Group: Women without Polycystic Ovary Syndrome0 interventions
Trial outcomes
Primary outcomes
1
Vaginal and gut microbiota composition before and after intervention recommended and in comparison to women without PCOS.
Evaluated by PCR ( ng/microl)
Time frame
Through study completion, an estimated period of 1 yearSecondary outcomes
1
Hirsutism
Change in hirsutism - subjectively reported by the women during clinic visits, on scale 0-4 (0-no change, 4-substantial improvement), and additionally evaluated before and after treatment by the Modified Ferriman-Gallwey Scoring (evaluating 9 body areas to assess hair growth (on 0-4 scale: 0-no hair growth to 4- extensive hair growth)
Time frame
Through study completion, an estimated period of 1 year2
Acne
Change in Acne sevirity - subjectively reported by the women during clinic visits - Mild/ Moderate /Severe
Time frame
Through study completion, an estimated period of 1 year3
Fertility
Sucess achieving pregnancy
Time frame
Through study completion, an estimated period of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: