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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03642600

Enrollment

Registered

2018-08-22

Start date

2019-02-28

Completion date

2020-07-03

Last updated

2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Obesity, PCOS

Brief 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.

Interventions

DIETARY_SUPPLEMENTdietary advice plus myo-inositol and folic acid

dietary advice and lifestyle interventions and myo-inositol

DRUGdietary advice plus Liraglutide Pen Injector

dietary advice and lifestyle interventions and liraglutide pen injector

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

* PCOS according to ROtterdam criteria * BMI ≥ 27 kg/m2 and at risk of metabolic syndrome or BMI ≥ 30 kg/m2

Exclusion criteria

* pregnancy * pancreatitis (in the past) * oral contraceptive pill use * inflammatory bowel disease * auto-immune disease * immuno-modulatory drugs * antidiabetic drugs * anti-inflammatory drugs

Design outcomes

Primary

Measure	Time frame
weight loss	32 weeks

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026