Probiotic Intervention in PCOS (ProPCO-RCT)

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Dietary Supplement: Probiotic Placebo; Drug: Metformin Hydrochloride; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04593459

160120200001

2020-000228-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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• Missing or withdrawn consent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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 3 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Probiotic Placebo

Metformin

Active Comparator group

Description:

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.

Treatment:

Drug: Metformin Hydrochloride