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

NCT ID: NCT06169566

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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PCOS- Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Intervention

synbiotics

Group Type ACTIVE_COMPARATOR

synbiotics

Intervention Type DIETARY_SUPPLEMENT

synbiotics

non-intervention

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type COMBINATION_PRODUCT

placebo

Interventions

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synbiotics

synbiotics

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

\- PCOS

Exclusion Criteria

* ATB use
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maharaj Nakorn Chiang Mai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ploywarong Rueangket

MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ploywarong Rueangket, MD

Role: PRINCIPAL_INVESTIGATOR

Department of obstetrics and gynecoloy

Locations

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Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, , Thailand

Site Status

Countries

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Thailand

Central Contacts

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Ploywarong Rueangket, MD.

Role: CONTACT

Phone: 66804492863

Email: [email protected]

Pisanu Rueangket

Role: CONTACT

Phone: 66804492863

Email: [email protected]

Facility Contacts

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Ploywarong Rueangket

Role: primary

Ploywarong Rueangket

Role: backup

Other Identifiers

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OBG-2566-0568

Identifier Type: -

Identifier Source: org_study_id