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Probiotic Modulates Vaginal Microflora

Primary Purpose

Microbial Colonization

Status
Recruiting
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Probiotic
placebo
Sponsored by
Min-Tze LIONG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Microbial Colonization focused on measuring probiotics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Generally, healthy women aged 18-80. - Currently free from urogenital infections such as urinary tract infection (UTI), bacterial vaginosis (BV), or yeast vaginitis.
  • Willing to commit throughout the experiment.

Exclusion Criteria:

  • Pregnant.
  • On vaginal suppository treatments within 4-weeks prior to entering the study.
  • On oral medication for vaginal illnesses or any vaginal therapy such as hormones and estrogen within 4-weeks prior to entering the study.
  • On long term medication (> 6 months) for any illnesses.
  • Have used vaginal estrogen cream, ring or tablet within 4-weeks prior to entering the study.
  • Have used vaginal moisturizers, lubricants or homeopathic preparations within 4-weeks prior to entering the study.
  • Have used spermicide agent within 4-weeks prior to entering the study.
  • Pelvic or any gynecologic surgery 6-months prior to entering the study.

Sites / Locations

  • International Islamic University MalaysiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

probiotic 9 log CFU/day

placebo

Arm Description

Intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.

placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as light-yellow powder.

Outcomes

Primary Outcome Measures

differences in general women's health
To evaluate differences in general women's health of women on probiotic and placebo via the use of the Women's Health Questionnaire (WHQ) questionnaire containing 37-items covering aspects of anxiety and depression, memory, sleep and sexual issues, on a 4-point Likert scale including some items with reverse scoring, with higher scores indicating poorer health status.
differences in immunity of women
To evaluate differences in immunity of women on probiotic and placebo in terms of blood immunity profiling via measuring concentrations of cytokines such as interleukin (IL)-1b using commercially available ELISA kit.
differences in gut microbiota profiles of women
To evaluate differences in gut microbiota profiles of women on probiotic and placebo via microbiota profiling using DNA of fecal samples amplified for bacterial 16S rRNA and analyzed for high-throughput community sequencing.

Secondary Outcome Measures

Full Information

First Posted
March 17, 2022
Last Updated
May 8, 2023
Sponsor
Min-Tze LIONG
Collaborators
International Islamic University Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05302687
Brief Title
Probiotic Modulates Vaginal Microflora
Official Title
Use of Probiotic to Modulate Vaginal Microflora and General Women's Health
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
January 15, 2025 (Anticipated)
Study Completion Date
January 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Min-Tze LIONG
Collaborators
International Islamic University Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of oral administration of probiotic at 9 log colony forming unit (CFU)/day on vaginal microbiota profiles compared to placebo via the use of vaginal self-swab microbiota profiling.
Detailed Description
To evaluate differences in general women's health of women on probiotic and placebo via the use of questionnaire. To evaluate differences in immunity of women on probiotic and placebo via blood immunity profiling. To evaluate differences in gut microbiota profiles of women on probiotic and placebo via blood fecal microbiota profiling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
Keywords
probiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A double-blind randomized placebo-controlled trial design has been chosen. Randomization for the parallel prevention phase will be carried out after checking the inclusion and exclusion criteria.
Masking
ParticipantCare ProviderInvestigator
Masking Description
The randomization will be performed by the study statistician, who had no contact with the participants. The allocation sequence will not available to any member of the research team until databases had been completed and locked. Since this is a double-blinded study, both the research team and subject will not know in which group the subject is assigned to.
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
probiotic 9 log CFU/day
Arm Type
Experimental
Arm Description
Intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as light-yellow powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
This project aims to evaluate differences in general women's health of women on probiotic and placebo via the use of questionnaire and evaluate differences in immunity of women on probiotic and placebo via blood immunity profiling. To evaluate differences in gut microbiota profiles of women on probiotic and placebo via blood fecal microbiota profiling.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
This project aims to evaluate differences in general women's health of women on probiotic and placebo via the use of questionnaire and evaluate differences in immunity of women on probiotic and placebo via blood immunity profiling. To evaluate differences in gut microbiota profiles of women on probiotic and placebo via blood fecal microbiota profiling.
Primary Outcome Measure Information:
Title
differences in general women's health
Description
To evaluate differences in general women's health of women on probiotic and placebo via the use of the Women's Health Questionnaire (WHQ) questionnaire containing 37-items covering aspects of anxiety and depression, memory, sleep and sexual issues, on a 4-point Likert scale including some items with reverse scoring, with higher scores indicating poorer health status.
Time Frame
12 weeks
Title
differences in immunity of women
Description
To evaluate differences in immunity of women on probiotic and placebo in terms of blood immunity profiling via measuring concentrations of cytokines such as interleukin (IL)-1b using commercially available ELISA kit.
Time Frame
12 weeks
Title
differences in gut microbiota profiles of women
Description
To evaluate differences in gut microbiota profiles of women on probiotic and placebo via microbiota profiling using DNA of fecal samples amplified for bacterial 16S rRNA and analyzed for high-throughput community sequencing.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Generally, healthy women aged 18-80. - Currently free from urogenital infections such as urinary tract infection (UTI), bacterial vaginosis (BV), or yeast vaginitis. Willing to commit throughout the experiment. Exclusion Criteria: Pregnant. On vaginal suppository treatments within 4-weeks prior to entering the study. On oral medication for vaginal illnesses or any vaginal therapy such as hormones and estrogen within 4-weeks prior to entering the study. On long term medication (> 6 months) for any illnesses. Have used vaginal estrogen cream, ring or tablet within 4-weeks prior to entering the study. Have used vaginal moisturizers, lubricants or homeopathic preparations within 4-weeks prior to entering the study. Have used spermicide agent within 4-weeks prior to entering the study. Pelvic or any gynecologic surgery 6-months prior to entering the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MingTze Liong
Phone
+60175938806
Email
liongmintze@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syahril Azizan Azha, Doctor
Organizational Affiliation
IIUM Kuantan Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Islamic University Malaysia
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
50728
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
Phone
(+603) 6421 6421
Email
webmaster@iium.edu.my

12. IPD Sharing Statement

Plan to Share IPD
No

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Probiotic Modulates Vaginal Microflora

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