The Synbiotics Effects in Polycystic Ovary Syndrome: A Ra... | NCT06169566

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

NCT06169566

Sponsor

Maharaj Nakorn Chiang Mai Hospital

Status

Unknown status

Last Update Posted

Dec 13, 2023Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

PCOS- Polycystic Ovary Syndrome

Interventions

synbiotics
placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Nov 27, 2023

First Submission Date that Met QC Criteria

Dec 5, 2023

First Posted Date

Dec 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2023

Last Update Posted Date

Dec 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ploywarong Rueangket, MD., Maharaj Nakorn Chiang Mai HospitalPrincipal Investigator

Lead Sponsor

Maharaj Nakorn Chiang Mai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator	synbiotics	Dietary Supplement: synbiotics
non-intervention	Placebo Comparator	placebo	Combination Product: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
synbiotics	Dietary Supplement	synbiotics	Intervention
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- PCOS

Exclusion Criteria:

ATB use

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ploywarong Rueangket, MD.	Contact	66804492863		ploywarong.24@gmail.com
Pisanu Rueangket	Contact	66804492863		ploywarong.24@gmail.com

Overall Officials

Name	Affiliation	Role
Ploywarong Rueangket, MD	Department of obstetrics and gynecoloy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maharaj Nakorn Chiang Mai Hospital		Chiang Mai		50200	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058616	Synbiotics

Ancestor Terms

ID	Term
D056692	Prebiotics
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition

Browse Leaves

Not provided

Browse Branches

Not provided