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Investigating the Role of Gut Health and Metabolic Factors in the Development of Polycystic Ovarian Syndrome Among Women in Gujarat

A multicentric case-control study on the role of metabolic and microbiological factors in the development of polycystic ovarian syndrome among women of Gujarat - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/077172
Enrollment
80
Registered
2024-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

None listed

Sponsors

Gujarat Technological University School of Pharmacy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The study involved PCOS-diagnosed and healthy controls from Gujarat clinics who will provide signed consent forms. Females aged 18-40 (Both inclusion) who are confirmed with a PCOS, based on the Rotterdam criteria. Women who are not pregnant or breastfeeding during the study period. Women who have no acute, hormonal, or neoplastic conditions and autoimmune diseases. Recruitment of healthy controls from hospitals, and educational institutions. Note: We will recruit age, diet, & BMI matched control. The same exclusion criteria will apply for the control.

Exclusion criteria

Exclusion criteria: The study will exclude smokers, alcoholics, non-vegetarians, and tobacco-chewing participants. This study will exclude participants who have used medications affecting insulin sensitivity (including those for blood pressure, steroids, cholesterol, hormonal contraceptives, antipsychotics, and antibiotics/prebiotics/probiotics) within the past 1 month.

Design outcomes

Primary

MeasureTime frame
The purpose of this research provides an understanding of the role of bile acid metabolite analysis and gut microbiota alteration between PCOS patients and control groups.Timepoint: 1 Year

Secondary

MeasureTime frame
Assessment and understanding the association of homeostasis model assessment for Insulin Resistance (HOMA-IR) scores between lean-obese PCOS patients and the control groups. Timepoint: 8 months;Understand the association of gut microbiota species with bile acid levels (correlation analysis using statistic software). Timepoint: 1 Year;Based on the analysis, select potential pathogenic factors contributing to the development of PCOS. Timepoint: 1 Year

Countries

India

Contacts

Public ContactMs Foram Ravat

Gujarat Technological University School of Pharmacy

ap_kashyap@gtu.edu.in9427979959

Outcome results

None listed

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