Efficacy of Metformin With and Without Probiotics in Women With PCOS

NCT07874646 | Completed

• 2 other identifiers: SVCP/IEC/DEC/2023/82EC/NEW/INIT/2021/1811
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective interventional study evaluated the effectiveness of metformin alone compared with metformin combined with probiotics in women with polycystic ovary syndrome (PCOS). The study included women aged 18-45 years diagnosed with PCOS according to the Rotterdam criteria. Participants received either metformin alone or metformin combined with probiotic supplementation for 12 weeks. The study assessed changes in hormonal parameters such as total testosterone (TT), sex hormone-binding globulin (SHBG), and free androgen index (FAI) to determine whether adding probiotics to metformin provided additional benefits in the management of PCOS.

Conditions

Poly Cystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; PCOS; Metformin; Probiotics; Hormonal profile; Menstrual regularity; Hyperandrogenism; Free androgen index; Sex hormone-binding globulin

Outcome Measures

Primary Outcomes (3)

• Change in serum free testosterone concentration

  Serum free testosterone will be measured in a fasting blood sample. The change from baseline to the end of the intervention will be compared between women receiving metformin plus probiotics and women receiving metformin alone. Unit of measure: ng/dL.

  Baseline and 3 months

• Change in free androgen index

  Free androgen index will be calculated as total testosterone divided by sex hormone binding globulin, multiplied by 100. The change from baseline to the end of the intervention will be compared between the two groups. Unit of measure: unitless index.

  Baseline and 3 months

• Menstrual regularity

  Menstrual regularity will be assessed from participant-reported cycle dates. A cycle is counted as regular when its length is 21 to 35 days. The number of women with regular cycles at the end of the intervention will be compared between the two groups. Unit of measure: number of participants.

  3 months

Secondary Outcomes (2)

• Change in polycystic ovary syndrome quality of life score

  Baseline and 3 months

• Change in body mass index (BMI)

  Baseline and 3 months

Study Arms (2)

Metformin alone

ACTIVE COMPARATOR

Participants received metformin 500 mg twice daily for 12 weeks.

Drug: Metformin

Metformin + Probiotics

EXPERIMENTAL

Participants received metformin 500 mg twice daily combined with a probiotic capsule twice daily after meals for 12 weeks.

Drug: Metformin; Dietary Supplement: Probiotics

Interventions

Metformin DRUG

Metformin 500 mg was administered orally twice daily for 12 weeks as the standard treatment for participants with polycystic ovary syndrome (PCOS).

Metformin + Probiotics; Metformin alone

Probiotics DIETARY_SUPPLEMENT

A probiotic capsule was administered orally twice daily after meals for 12 weeks in combination with metformin. Each capsule contained fructooligosaccharide 300 mg and Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium longum, Saccharomyces boulardii, and Streptococcus thermophilus.

Metformin + Probiotics

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal women aged 18-45 years.
• Diagnosis of PCOS based on the Rotterdam criteria.
• Body mass index (BMI) between 18.5 and 35 kg/m2.

You may not qualify if:

• Pregnancy or lactation
• Use of hormonal medications or supplements within the past 3 months.
• History of chronic gastrointestinal disorders
• Severe hepatic or renal impairment.
• Known allergy or intolerance to metformin.
• T2DM,Thyroid disorder,adrenal hyperplasia.
• Intake of antiobesity and antidepressants in the last 3 months.

Sponsors & Collaborators

• Dhivyaprasath Palaniappan: lead

Study Sites (1)

Vivekanandha Medical Care Hospital

Tiruchengode, Tamil Nadu, 637205, India

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism

Interventions

Metformin; Probiotics

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dhivyaprasath P, Pharm D

  Swamy Vivekanandha College of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is a prospective interventional study, but it is not a drug-development trial intended to evaluate a new investigational drug through Phases 1-4. we are studying metformin ± probiotics in women with PCOS in a clinical research setting.

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 15, 2026
• Study Start: March 27, 2024
• Primary Completion: August 30, 2024
• Study Completion: December 27, 2024
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)