Clinical trial · Interventional
Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome
Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome: a Randomized, Parallel Study
NCT03336840CI-TRIAL-00036905unknownN/AClinicalTrials.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 purpose of this clinical trial is to evaluate the safety and effectiveness on the clinical and biological parameters of reproductive-aged PCOS women after a 12-week metformin and/or probiotics administration.
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 |
|---|---|---|---|
| 1. Metformin tablets; 2. ProMetS probiotics powder | Drug | — | UNRESOLVED |
| Metformin tablets | Drug | Metformin | ALIAS |
| ProMetS probiotics powder | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Metformin
- interventionNames
- Drug: Metformin tablets
- type
- EXPERIMENTAL
- label
- Probiotics
- interventionNames
- Drug: ProMetS probiotics powder
- type
- EXPERIMENTAL
- label
- Metformin and Probiotics
- interventionNames
- Drug: 1. Metformin tablets; 2. ProMetS probiotics powder
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Premenopausal between 18-40 years of age. 2. Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria. Exclusion Criteria: 1. During the pregnancy and lactation period. 2. Significant impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease. 3. Use of antibiotics within 3 months. 4. Symptoms of any infection at screening. 5. Immunodeficient or use of immunosuppressive drugs. 6. Use of products containing prebiotics or probiotics within the last 3 months. 7. Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder). 8. Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator
References
Publications (0)
Data not yet available
No reference posted for this study.