drugset / Trial / NCT03642600

The Gut Microbiome in Women With Polycystic Ovary Syndrome

NCT03642600

Phase 4 Completed 21 enrolled Universitaire Ziekenhuizen KU Leuven
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-02-28
Primary completion
2020-02-01
Completion
2020-07-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Liraglutide Peptide 3 mg