Trial | NCT04593459  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    180
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.
Study Started
Nov 03
2020
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Dec 31
2023
Anticipated
Last Update
Apr 06
2022

Dietary Supplement Probiotic

See Arm description

Drug Metformin Hydrochloride

See Arm description

Dietary Supplement Probiotic Placebo

See Arm description

Probiotic Experimental

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

Placebo Placebo Comparator

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 Active Comparator

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.

Criteria 

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
No Results Posted