A Phase 4 interventional study of Probiotic and Metformin Hydrochloride in Polycystic Ovary Syndrome, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by Medical University of Graz · Phase 4, Interventional, and Treatment
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 112 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
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Exclusion Criteria:
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
Dietary Supplement: Probiotic
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
Dietary Supplement: Probiotic Placebo
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.
Drug: Metformin Hydrochloride
See Arm description
See Arm description
See Arm description
Free testosterone
Changes in free testosterone levels \[pg/ml\] in serum after intervention
Time frame: 6 months
Anti-Müllerian hormone (AMH)
Changes in AMH levels in serum after intervention \[ng/ml\]
Time frame: 6 months
Androstenedione
Changes in androstenedione levels in serum after intervention \[ng/ml\]
Time frame: 6 months
Dehydroepiandrosterone-sulphate (DHEA-S)
Changes in DHEA-S levels in serum after intervention \[µg/ml\]
Time frame: 6 months
17-Hydroxyprogesterone (17-OH-progesterone)
Changes in 17-OH-progesterone levels in serum after intervention \[ng/ml\]
Time frame: 6 months
17-OH-estradiol
Changes in 17-OH-estradiol levels in serum after intervention \[ng/ml\]
Time frame: 6 months
Total testosterone
Changes in total testosterone levels in serum after intervention \[ng/ml\]
Time frame: 6 months
25-OH-cholecalciferol
Changes in 25-OH-cholecalciferol levels in serum after intervention \[ng/ml\]
Time frame: 6 months
Luteinizing hormone (LH), Follicle-stimulating hormone (FSH)
Changes in LH and FSH levels in serum after intervention \[mU/ml\]
Time frame: 6 months
LH to FSH ratio
Changes in LH to FSH ratio after intervention \[1\]
Time frame: 6 months
Insulin
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) \[mU/l\]
Time frame: 6 months
Glucose
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) \[mg/dl\]
Time frame: 6 months
Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index
Changes in HOMA-IR index (fasting insulin \[mU/l\] \* fasting glucose \[mg/dl\]/405) after intervention
Time frame: 6 months
Glucose mean
Changes in mean glucose levels (measured with oral glucose tolerance test with the formula g=(glucose0 + 2\*glucose30 + 3\*glucose60 + 2\*glucose120)/8 \[mg/dl\]
Time frame: 6 months
Insulin mean
Changes in mean insulin levels (measured with oral glucose tolerance test with the formula i=(insulin0 + 2\*insulin30 + 3\*insulin0 + 2\*insulin120)/8 \[mU/l\]
Time frame: 6 months
Matsuda index
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))
Time frame: 6 months
Hirsutism
measured by modified Ferriman-Gallwey-score (mFG-score), ranging from 0 to 36, with 0 being the best possible value and 36 the worst
Time frame: 6 months
Body-mass-index (BMI)
BMI measured with the formula BMI=weight \[kg\]/height² \[m\]
Time frame: 6 months
waist-to-hip ratio
Calculated with the formula: waist circumference/hip circumference \[1\]
Time frame: 6 months
Sucrose-lactulose-mannitol test
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.
Time frame: 6 months
Diaminooxidase
Changes in serum diaminooxidase levels after intervention
Time frame: 6 months
Stool and serum zonulin
Changes in stool and serum zonulin levels after intervention \[ng/ml\]
Time frame: 6 months
Lipopolysaccharide
Changes in lipopolysaccharide levels after intervention
Time frame: 6 months
Soluble cluster of differentiation (sCD14)
Changes in sCD14 levels in serum after intervention
Time frame: 6 months
Calprotectin
Changes in stool calprotectin levels after intervention
Time frame: 6 months
Bacterial DNA
Changes in bacterial DNA amounts in serum after intervention
Time frame: 6 months
Gut lumen and mucosa microbiome composition and metagenomic profile
Measured from stool samples via 16S-RNA gene sequencing
Time frame: 6 months
Phytoestrogen production
Changes in daidzein and equol concentrations after intervention \[ng/ml\] measured in urine samples of participants after ingestion of soy milk
Time frame: 6 months
Equol producer status
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
Time frame: 6 months
Quality of life (QOL)
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.
Time frame: 6 months
QOL
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.
Time frame: 6 months
QOL
Quality of Life measured by a PCOS questionnaire ranging from 0 to 156, with 0 being the best possible score and 156 the worst
Time frame: 6 months
Lipid metabolism
Low-density lipoproteins (LDL), high-density lipoproteins (HDL), lipoprotein a (LP(a)), triacylglycerols
Time frame: 6 months
Fluorescence-activated cell sorting (FACS) analysis
B cell subtypes measured via FACS from whole blood
Time frame: 6 months
Plan to share: Yes — 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
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Medical University of Graz