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

Not Applicable

Not yet recruiting

• Conditions: PCOS- Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: synbiotics; Combination Product: placebo

• Registration Number: NCT06169566
• Lead Sponsor: Maharaj Nakorn Chiang Mai Hospital

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

Study Timeline

• Study First Submitted: 2023-11-27
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-05
• Last Update Submitted: 2023-12-05
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13
• Study Start: 2024-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• PCOS

Exclusion Criteria

• ATB use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	synbiotics	synbiotics
non-intervention	placebo	placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maharaj Nakorn Chiang Mai Hospital; 🇹🇭 Chiang Mai, Thailand