PCOS- Polycystic Ovary SyndromePCOSNCT06169566
The Synbiotics Effects in Polycystic Ovary Syndrome: A Randomized Controlled Trial
A study testing synbiotics in people with PCOS- Polycystic Ovary Syndrome, run by Maharaj Nakorn Chiang Mai Hospital at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS- Polycystic Ovary Syndrome
- What is being tested?
- synbiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PCOS
Who cannot join
- ATB use
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Ploywarong Rueangket, 800-555-5555, ploywarong.24@gmail.com
Ploywarong Rueangket, ploywarong.24@gmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- PCOS- Polycystic Ovary Syndrome
- Being tested
- synbiotics, placebo
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synbioticsDietary supplement
synbiotics
placeboCombination product
placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | synbiotics Receives: Dietary Supplement: synbiotics |
| non-intervention | Placebo comparator | placebo Receives: Combination Product: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
synbiotics effect on reproductive and cardiovascular risk
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS- Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maharaj Nakorn Chiang Mai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ploywarong Rueangket, Maharaj Nakorn Chiang Mai Hospital
- Investigators
- Ploywarong Rueangket, MD, Principal investigator, Department of obstetrics and gynecoloy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169566
- Sponsor's protocol ID
- OBG-2566-0568
- Acronym
- PCOS
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Gut Microbiome in Thai Women With Polycystic Ovary Syndrome and the Synbiotics Effect on Reproductive and Cardiovascular Risk: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06169566
- Acronym / sponsor ID
- PCOS / OBG-2566-0568
- Conditions
- PCOS- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maharaj Nakorn Chiang Mai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: synbioticssynbiotics |
| non-intervention | Placebo comparator | Combination Product: placeboplacebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- PCOS
Key exclusion criteria (1 listed)
- ATB use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| synbioticssynbiotics | Dietary supplement | Intervention |
| placeboplacebo | Combination product | non-intervention |
Primary outcome
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
1 secondary outcome
synbiotics effect on reproductive and cardiovascular risk
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ploywarong Rueangket, MD principal investigator
Department of obstetrics and gynecoloy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing synbiotics in people with PCOS- Polycystic Ovary Syndrome, run by Maharaj Nakorn Chiang Mai Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ploywarong Rueangket, MD. (66804492863, ploywarong.24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome in polycystic ovary syndrome (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.