The Synbiotics Effects in Polycystic Ovary Syndrome: A Randomized Controlled Trial
PCOS
Analysis of Gut Microbiome in Thai Women With Polycystic Ovary Syndrome and the Synbiotics Effect on Reproductive and Cardiovascular Risk: A Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
December 13, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedDecember 13, 2023
December 1, 2023
2 years
November 27, 2023
December 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Gut microbiome in polycystic ovary syndrome
Gut microbiome will be evaluated by metagenomic analysis of the stool exam of PCOS patient before and after receive synbiotics
12 months
Secondary Outcomes (1)
synbiotics effect on reproductive and cardiovascular risk
12 months
Study Arms (2)
Intervention
ACTIVE COMPARATORsynbiotics
non-intervention
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- \- PCOS
You may not qualify if:
- ATB use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ploywarong Rueangket, MD
Department of obstetrics and gynecoloy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD.
Study Record Dates
First Submitted
November 27, 2023
First Posted
December 13, 2023
Study Start
January 1, 2024
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
December 13, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share