The Gut Microbiome in Women With Polycystic Ovary Syndrome

What Was Tested

This registered phase 4 trial tested Liraglutide for pcos.

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.

It had two arms (groups): dietary advice plus myo-inositol and folic acid (active comparator) and dietary advice plus liraglutide pen injector (active comparator).

The registry classes the interventions as dietary supplement and drug.

Who Took Part

Enrollment: 21 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: PCOS according to ROtterdam criteria. BMI ≥ 27 kg/m2 and at risk of metabolic syndrome or BMI ≥ 30 kg/m2.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: pancreatitis (in the past); oral contraceptive pill use; inflammatory bowel disease.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the pcos participants stayed in one arm throughout.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2019-02-28 with completion listed for 2020-02-01.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: weight loss (time frame: 32 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 21 people with pcos.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, PCOS research.