Clinical trial · Interventional
Probiotic Intervention in PCOS
Probiotic Dietary Intervention in Polycystic Ovary Syndrome (PCOS) - A Randomized Controlled Trial
NCT04593459CI-TRIAL-00075347ProPCO-RCTcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin Hydrochloride | Drug | Metformin | ALIAS |
| Probiotic | Dietary Supplement | — | UNRESOLVED |
| Probiotic Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Probiotic
- 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
- interventionNames
- Dietary Supplement: Probiotic
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- 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
- interventionNames
- Dietary Supplement: Probiotic Placebo
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDLindheim L, Bashir M, Munzker J, Trummer C, Zachhuber V, Leber B, Horvath A, Pieber TR, Gorkiewicz G, Stadlbauer V, Obermayer-Pietsch B. Alterations in Gut Microbiome Composition and Barrier Function Are Associated with Reproductive and Metabolic Defects in Women with Polycystic Ovary Syndrome (PCOS): A Pilot Study. PLoS One. 2017 Jan 3;12(1):e0168390. doi: 10.1371/journal.pone.0168390. eCollection 2017. PMID 28045919
- BACKGROUNDHaudum C, Lindheim L, Ascani A, Trummer C, Horvath A, Munzker J, Obermayer-Pietsch B. Impact of Short-Term Isoflavone Intervention in Polycystic Ovary Syndrome (PCOS) Patients on Microbiota Composition and Metagenomics. Nutrients. 2020 Jun 1;12(6):1622. doi: 10.3390/nu12061622. PMID 32492805
- DERIVEDBorzan V, Riedl R, Obermayer-Pietsch B. Probiotic vs. placebo and metformin: probiotic dietary intervention in polycystic ovary syndrome - A randomized controlled trial. BMC Endocr Disord. 2023 Apr 17;23(1):82. doi: 10.1186/s12902-023-01294-6. PMID 37062834