Probiotic Intervention in PCOS

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Collaborators: Institut AllergoSan; Winclove Probiotics
• Treatments: Metformin

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• Missing or withdrawn consent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