Polycystic Ovary Syndrome (PCOS) is a hormonal and metabolic disorder affecting up to 20 percent of women worldwide, depending on diagnostic criteria. A very common definition of PCOS based on the revised Rotterdam criteria includes at least two out of three symptoms: • Oligo-/Amenorrhea • Polycystic ovarian morphology (PCOM) • Clinical or biochemical hyperandrogenism
Conditions
Interventions
Trade Name: Glucophage
Product Name: Metformin
Product Code: A10BA02
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg m
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Premenopausal women with PCOS aged 18 to 45 years meeting two out of three Rotterdam criteria: polycystic ovarian morphology, biochemical and/or clinical hyperandrogenism and oligo-/anovulation ? Signed informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Missing or withdrawn consent ? Hyperandrogenism of a cause other than PCOS (Cushing´s syndrome, hyperprolactinemia, adrenal tumours, congenital adrenal hyperplasia, rare genetic disorders) ? Pregnancy or nursing period (first 6 months after giving birth) ? Soy or other allergies with respect to study procedures ? Diabetes mellitus type 1 ? Chronic inflammatory bowel disease, history of cancer in the gastrointestinal tract or acute gastrointestinal infection ? Any malignancies that required treatment within the last 3 years prior to study procedures ? Any other chronic disease requiring medical check-ups or hospital treatments at least once every three months (exception: diabetes mellitus type 2) ? Major surgery in the gastrointestinal tract (e.g. colectomy, gut segment excision with stoma surgery, Whipple´s surgery.) Surgical removal of the appendix and/or the gall bladder is NOT considered major surgery. ? Therapy with antidiabetic drugs (metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 analogs, SGLT-2 inhibitors, insulin variants) within the last six months prior to study procedures ? Therapy with proton pump inhibitors within the last six months prior to study procedures ? Therapy with hormonal contraceptives or systemic (oral) intake of steroids ? Oral or intravenous therapy with antibiotics less than three months before the onset of study procedures ? Alcohol and/or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our primary aim is to establish probiotics as a possible PCOS treatment option by showing a significant improvement of free testosterone levels in comparison to placebo after a 6-month intervention period.;Secondary Objective: Our secondary objectives are: to compare the secondary outcome parameters to placebo and show a significant improvement in the probiotic group to compare the ourcome parameters of the probiotic treatment to metformin;Primary end point(s): The primary endpoint of the study is a change in serum free testosterone concentration in women with PCOS after a 6-month intervention with probiotics compared to placebo treatment.;Timepoint(s) of evaluation of this end point: baseline, after 6 months intervention, and an additional 6 months (voluntary) follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Glucose metabolism (Oral glucose tolerance test) ? Other hormonal parameters of PCOS (AMH; androstenedione; FSH; LH; DHEAS; 17-OH-progesterone; 17-OH-estradiole; dihydrotestosterone, total testosterone) ? Hirsutism (modified Ferriman-Galway-score) ? Body weight (BMI; waist-to-hip-ratio) ? Gut permeability and inflammation (Functional sugar test; surrogate parameters: serum diaminooxydase; stool zonulin; calprotectin; lipopolysaccharide; soluble CD14; bacterial DNA) ? Gut lumen and mucosa microbiome composition and metagenomic profile (16S-RNA gene sequencing) ? Phytoestrogen production (soy challenge test; urine daidzein and equol concentrations) ? Quality of life (PCOS questionnaire; depression questionnaires; diet questionnaires);Timepoint(s) of evaluation of this end point: baseline, after 6 months intervention, and an additional 6 months (voluntary) follow-up | — |
Countries
Austria
Contacts
Public ContactEndokrinologieambulanz
Medical University of Graz
Outcome results
None listed