Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Micronutrients

Anti-Arrhythmia Agents

Channel Blockers

Analgesics

Anticonvulsants

Central Nervous System Depressants

Reproductive Control Agents

Bone Density Conservation Agents

Other Dietary Supplements

Vitamins

Metformin

Magnesium Sulfate

Vitamin D

Cholecalciferol

Manganese

Acidophilus

Vitamin D3

Calciferol

Probiotic product consisting of these 7 bacterial strains:

* Lactobacillus salivarius W57
* Lactobacillus casei W56
* Lactobacillus rhamnosus W71
* Lactococcus lactis W58
* Enterococcus faecium W54
* Lactobacillus plantarum W62
* Lactobacillus acidophilus W22

Additional ingredients: Corn starch, maltodextrin, fructo-oligosaccharides, galacto-oligosaccharides, polydextrose, plant proteins, potassium chloride, magnesium sulfate, bacterial strains, manganese sulfate, lactose, 2000 IU vitamin D

Participants ingest one sachet of powder (5 grams) in 200 ml of water per day for 6 months

Similar to probiotic product in optics and smell, less ingredients and no bacterial strains or vitamin D

Ingredients: Corn starch, maltodextrin, potassium chloride, magnesium sulphate, manganese sulphate

Metformin is an established drug for treating PCOS-related symptoms. The investigators are comparing the probiotic not only to a placebo group, but also to the benchmark treatment.

Participants in the metformin arm will start treatment with 500 mg daily for the first week, then increasing the dose to 2x500 mg daily for the duration of the intervention.

Probiotic

Metformin Hydrochloride

Probiotic Placebo

Barbara Obermayer-Pietsch, Prof. MD

The investigators are conducting a double-blinded randomized controlled trial to determine whether a probiotic mixture is effective in reducing PCOS-related symptoms. For this purpose, 180 participants will be recruited in three intervention arms (Probiotic, Placebo and Metformin), with 60 participants per arm. The intervention period will last 6 months, with extensive medical history, blood work, urine and stool analysis at the beginning and the conclusion of the trial.

Probiotic vs placebo (double-blinded) vs metformin (open-label)

Only the probiotic and placebo are blinded, metformin is an open intervention arm

Probiotic Intervention in PCOS

Probiotic Dietary Intervention in Polycystic Ovary Syndrome (PCOS) - A Randomized Controlled Trial

For research and cooperation purposes, pseudonymized individual participant data may be shared with other researchers, the decision to do so lies with the principal investigator. In case of publication of our results in a peer-reviewed journal, all relevant data will be made publicly accessible without any personal information

Low-density lipoproteins (LDL), high-density lipoproteins (HDL), lipoprotein a (LP(a)), triacylglycerols

B cell subtypes measured via FACS from whole blood

Changes in free testosterone levels \[pg/ml\] in serum after intervention

Changes in AMH levels in serum after intervention \[ng/ml\]

Changes in androstenedione levels in serum after intervention \[ng/ml\]

Changes in DHEA-S levels in serum after intervention \[µg/ml\]

Changes in 17-OH-progesterone levels in serum after intervention \[ng/ml\]

Changes in 17-OH-estradiol levels in serum after intervention \[ng/ml\]

Changes in total testosterone levels in serum after intervention \[ng/ml\]

Changes in 25-OH-cholecalciferol levels in serum after intervention \[ng/ml\]

Changes in LH and FSH levels in serum after intervention \[mU/ml\]

Changes in LH to FSH ratio after intervention \[1\]

Changes in insulin levels in serum as measured with a two-hour oral glucose tolerance test (75 mg glucose in 300 ml water, blood draws at 0 minutes, 30 min, 60 min and 120 min) \[mU/l\]

Changes in glucose levels in sodium-fluoride plasma as measured with a two-hour oral glucose tolerance test (75 mg glucose in 300 ml water, blood draws at 0 minutes, 30 min, 60 min and 120 min) \[mg/dl\]

Changes in HOMA-IR index (fasting insulin \[mU/l\] \* fasting glucose \[mg/dl\]/405) after intervention

Changes in mean glucose levels (measured with oral glucose tolerance test with the formula g=(glucose0 + 2\*glucose30 + 3\*glucose60 + 2\*glucose120)/8 \[mg/dl\]

Changes in mean insulin levels (measured with oral glucose tolerance test with the formula i=(insulin0 + 2\*insulin30 + 3\*insulin0 + 2\*insulin120)/8 \[mU/l\]

Changes in matsuda index after intervention measured with the formula M=10000/squareroot(glucose0 \* insulin0 \* glucose mean (see outcome 14) \* insulin mean (see outcome 15))

measured by modified Ferriman-Gallwey-score (mFG-score), ranging from 0 to 36, with 0 being the best possible value and 36 the worst

BMI measured with the formula BMI=weight \[kg\]/height² \[m\]

Calculated with the formula: waist circumference/hip circumference \[1\]

Functional gut permeability test consisting of ingesting 20 g sucrose, 5 g mannitol and 10 g lactulose in 100 ml water solution. Measurement of those three component concentrations in urine collected for 5 hours after solution ingestion by the participants. Lactulose to mannitol ratio may be calculated.

Changes in serum diaminooxidase levels after intervention

Changes in stool and serum zonulin levels after intervention \[ng/ml\]

Changes in lipopolysaccharide levels after intervention

Changes in sCD14 levels in serum after intervention

Changes in stool calprotectin levels after intervention

Changes in bacterial DNA amounts in serum after intervention

Measured from stool samples via 16S-RNA gene sequencing

Changes in daidzein and equol concentrations after intervention \[ng/ml\] measured in urine samples of participants after ingestion of soy milk

Equol producer status as determined by the decadic logarithm of the equol/daidzein ratio \[1\]: A value above -0.5 is defined as an equol producer

QOL assessed by General Depression Scale (German: Allgemeine Depressionsskala), German equivalent of the Depression Scale by the Center for Epidemiological Studies (CES-D). The scale ranges from 0 to 60, with 0 being the best possible score and 60 the worst.

QOL assessed by Beck´s Depression Inventory (BDI), a scale ranging from 0 to 63, with 0 being the best possible score and 63 the worst.

Quality of Life measured by a PCOS questionnaire ranging from 0 to 156, with 0 being the best possible score and 156 the worst

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Probiotic Intervention in PCOS	NCT04593459	Polycystic Ovar...	Probiotic Metformin Hydro... Probiotic Place...	18 Years - 45 Years	Medical University of Graz
Probiotic Intervention in PCOS	NCT04593459	Polycystic Ovar...	Probiotic Metformin Hydro... Probiotic Place...	18 Years - 45 Years	Medical University of Graz

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