The Synbiotics Effects in Polycystic Ovary Syndrome: A Randomized Controlled Trial

Analysis of Gut Microbiome in Thai Women With Polycystic Ovary Syndrome and the Synbiotics Effect on Reproductive and Cardiovascular Risk: A Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06169566

Acronym

PCOS

Enrollment

Registered

2023-12-13

Start date

2024-01-01

Completion date

2025-12-31

Last updated

2023-12-13

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

Conditions

PCOS- Polycystic Ovary Syndrome

Brief summary

The goal of this clinical trial is to compare the effect of synbiotics and placebo in Thai women with polycystic ovary syndrome. The main questions it aims to answer are: * Do synbiotics have a positive effect on the gut microbiome? * Do synbiotics have a positive effect on reproductive outcomes? * Do synbiotics have a positive effect on cardiovascular outcomes? Participants will be randomized, and blinded to receive either synbiotics or placebo. While placebo is a comparison group: Researchers will compare with placebo to see if the effects on reproductive and cardiovascular risk differ.

Detailed description

Analysis of gut microbiome in Thai women with polycystic ovary syndrome and the synbiotics effect on reproductive and cardiovascular risk: A randomized controlled trial

Interventions

DIETARY_SUPPLEMENTsynbiotics

synbiotics

COMBINATION_PRODUCTplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

\- PCOS

Exclusion criteria

* ATB use

Design outcomes

Primary

Measure	Time frame	Description
Gut microbiome in polycystic ovary syndrome	12 months	Gut microbiome will be evaluated by metagenomic analysis of the stool exam of PCOS patient before and after receive synbiotics

Secondary

Measure	Time frame	Description
synbiotics effect on reproductive and cardiovascular risk	12 months	evaluation of the reproductive clinical (menstrual regularity, polycystic ovarian morphology on the ultrasound) and serum marker of cardiovascular risk (Lipid profile, HbA1C, fasting blood glucose, hsCRP) will be evaluated compare between synbiotics and placebo groups

Countries

Thailand

Contacts

Primary ContactPloywarong Rueangket, MD.

ploywarong.24@gmail.com66804492863

Backup ContactPisanu Rueangket