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Completed

NCT Number: NCT04593459

Probiotic Intervention in PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Graz, Division of Endocrinology and Diabetology

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Polycystic Ovary Syndrome diagnosed based on at least two out of three rotterdam criteria: hyperandrogenism, polycystic ovarian morphology, oligo-/anovulation
  • signed informed consent

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  • Missing or withdrawn consent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, dipeptidyl peptidase 4 (DPP-4) inhibitors, Glucagon-like peptide 1 (GLP-1) analogs, sodium-glucose-cotransporter 2 (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 within the last six months prior to study procedures
  • Oral or intravenous therapy with antibiotics less than three months before the onset of study procedures
  • Alcohol and/or drug abuse

Treatment and study plan

Probiotic

Dietary Supplement

See Arm description

Metformin Hydrochloride

Drug

See Arm description

Probiotic placebo

Dietary Supplement

See Arm description

Primary outcomes

  1. Free testosterone

    Time frame: 6 months

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

Secondary outcomes

  1. Anti-Müllerian hormone (AMH)

    Time frame: 6 months

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

  2. Androstenedione

    Time frame: 6 months

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

  3. Dehydroepiandrosterone-sulphate (DHEA-S)

    Time frame: 6 months

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

  4. 17-Hydroxyprogesterone (17-OH-progesterone)

    Time frame: 6 months

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

  5. 17-OH-estradiol

    Time frame: 6 months

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

  6. Total testosterone

    Time frame: 6 months

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

  7. 25-OH-cholecalciferol

    Time frame: 6 months

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

  8. Luteinizing hormone (LH), Follicle-stimulating hormone (FSH)

    Time frame: 6 months

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

  9. LH to FSH ratio

    Time frame: 6 months

    Changes in LH to FSH ratio after intervention [1]

  10. Insulin

    Time frame: 6 months

    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]

  11. Glucose

    Time frame: 6 months

    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]

  12. Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index

    Time frame: 6 months

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

  13. Glucose mean

    Time frame: 6 months

    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]

  14. Insulin mean

    Time frame: 6 months

    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]

  15. Matsuda index

    Time frame: 6 months

    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))

  16. Hirsutism

    Time frame: 6 months

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

  17. Body-mass-index (BMI)

    Time frame: 6 months

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

  18. waist-to-hip ratio

    Time frame: 6 months

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

  19. Sucrose-lactulose-mannitol test

    Time frame: 6 months

    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.

  20. Diaminooxidase

    Time frame: 6 months

    Changes in serum diaminooxidase levels after intervention

  21. Stool and serum zonulin

    Time frame: 6 months

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

  22. Lipopolysaccharide

    Time frame: 6 months

    Changes in lipopolysaccharide levels after intervention

  23. Soluble cluster of differentiation (sCD14)

    Time frame: 6 months

    Changes in sCD14 levels in serum after intervention

  24. Calprotectin

    Time frame: 6 months

    Changes in stool calprotectin levels after intervention

  25. Bacterial DNA

    Time frame: 6 months

    Changes in bacterial DNA amounts in serum after intervention

  26. Gut lumen and mucosa microbiome composition and metagenomic profile

    Time frame: 6 months

    Measured from stool samples via 16S-RNA gene sequencing

  27. Phytoestrogen production

    Time frame: 6 months

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

  28. Equol producer status

    Time frame: 6 months

    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

  29. Quality of life (QOL)

    Time frame: 6 months

    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.

  30. QOL

    Time frame: 6 months

    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.

  31. QOL

    Time frame: 6 months

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

Other outcomes

  1. Lipid metabolism

    Time frame: 6 months

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

  2. Fluorescence-activated cell sorting (FACS) analysis

    Time frame: 6 months

    B cell subtypes measured via FACS from whole blood

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Institut AllergoSan
  • Winclove Probiotics B.V.

Registry information

Official study title

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

Acronym: ProPCO-RCT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2020
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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