The Gut Microbiome in Women With Polycystic Ovary Syndrome

NCT03642600 · Completed

Last updated 2026-05-28

This clinical trial is studying how changes in gut bacteria may affect weight loss in women who have polycystic ovary syndrome (PCOS), obesity, or metabolic syndrome.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 21 people

Who can join Ages 18–40 · female only

Timeline Started 2019-02 · est. completion 2020-07

Where 1 site · Belgium

What this study is testing ClinicalTrials.gov NCT03642600 ↗

Description as written by the study sponsor.

Testing two different strategies for weight loss intervention and revealing possible changes in composition of gut microbiota, in order to provide more insight in the effect of dietary changes and weight loss treatments on gut microbiome in overweight and obese women with polycystic ovary syndrome (PCOS). The two strategies are: * dietary advice plus myo-inositol and folic acid * dietary advice plus liraglutide, glucagon-like peptide-1 (GLP-1) receptor agonist Primary outcome will be weight loss. Secondary outcomes are longitudinal changes in clinical features associated with PCOS and metabolic syndrome, longitudinal changes in gut microbiome with interventions. Subjects will be treated during 16 weeks and follow-up will take 16 weeks after stop of treatment.

Treatments tested

dietary advice plus myo-inositol and folic acid Dietary supplement

dietary advice and lifestyle interventions and myo-inositol
dietary advice plus Liraglutide Pen Injector Drug

dietary advice and lifestyle interventions and liraglutide pen injector

Main thing measured	weight loss
Sponsor	Universitaire Ziekenhuizen KU Leuven
Conditions studied	PCOS, Obesity, Metabolic Syndrome
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03642600 ↗