A study exploring How Probiotics and Metformin Works to Improve PCOS patient Health

Synergistic Effects of Probiotic Supplementation and Metformin on Inflammatory and Metabolic Biomarkers in Women With PCOS - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094113

Enrollment

138

Registered

2025-09-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: T. METFORMIN: 1000mg/ day Twice daily Oral for 3 months Intervention2: PROBIOTICS: Each capsule contains Lactobacillus crispatus 1 billion CFU Lactobacillus rhamnosus 1 billion CFU La

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-40 years meeting Rotterdam criteria for PCOS 2. Patients willing to participate

Exclusion criteria

Exclusion criteria: Patients with diabetes mellitus, hypo or hyperthyroidism, or Cushing syndrome, or any other conditions leading to hyperandrogenism. 2. Patients during pregnancy or lactation 3. Patients taking antibiotics, probiotics/prebiotics within 3 months or using oral proton pump inhibitors or laxatives/drugs for treatment of acne, alopecia, or hirsutism within 6 months. 4. Any patient on or started on hormonal treatment during the study period.

Design outcomes

Primary

Measure	Time frame
Changes in serum/fecal calprotectin and acylated ghrelin levelsTimepoint: 0 month and 3 months	—

Secondary

Measure	Time frame
Changes in insulin resistance markers, hyperandrogenism markersTimepoint: 0 month and 3 months	—

Countries

India

Contacts

Public ContactDr Suchanda Sahu

All India Institute of Medical Sciences

biochem_suchanda@aiimsbhubaneswar.edu.in9438884031

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026