NCT03642600

The Gut Microbiome in Women With Polycystic Ovary Syndrome

Novel Strategies in Weight Loss in Women With Polycystic Ovary Syndrome: do Changes in the Gut Microbiome Play a Role?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• PCOS
• Obesity
• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	dietary advice plus myo-inositol and folic acid	dietary advice and lifestyle interventions and myo-inositol
DRUG	dietary advice plus Liraglutide Pen Injector	dietary advice and lifestyle interventions and liraglutide pen injector

Timeline

• Start date: 2019-02-28
• Primary completion: 2020-02-01
• Completion: 2020-07-03
• First posted: 2018-08-22
• Last updated: 2020-11-04

Locations

1 site across 1 country: Belgium