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

December 5, 2023 updated by: Ploywarong Rueangket, Maharaj Nakorn Chiang Mai Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- PCOS

Exclusion Criteria:

  • ATB use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
synbiotics
Dietary supplement: synbiotics
synbiotics
Placebo Comparator: non-intervention
placebo
Combination product: placebo
placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
synbiotics effect on reproductive and cardiovascular risk
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maharaj Nakorn Chiang Mai Hospital

Investigators

  • Principal Investigator: Ploywarong Rueangket, MD, Department of obstetrics and gynecoloy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Estimated)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBG-2566-0568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PCOS- Polycystic Ovary Syndrome

Clinical Trials on synbiotics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe