Probiotic Intervention in PCOS

Plain-language summary

This study examines the effects of a probiotic supplement and Metformin in women with polycystic ovary syndrome (PCOS). It enrolled women diagnosed with PCOS according to the Rotterdam criteria. The study was conducted in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Medical University of Graz

Intervention

Probiotic, Metformin Hydrochloride, Probiotic Placebo

Start date

11/3/2020

Estimated completion

10/16/2023

Countries

Austria

Related genes

Locations

• Graz, Austria

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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* Missing or withdrawn consent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