Probiotic Modulates Vaginal Microflora

Min-Tze LIONG112 enrolled

Overview

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.

1. To evaluate differences in general women's health of women on probiotic and placebo via the use of questionnaire. 2. To evaluate differences in immunity of women on probiotic and placebo via blood immunity profiling. 3. To evaluate differences in gut microbiota profiles of women on probiotic and placebo via blood fecal microbiota profiling.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

112

Conditions

Microbial Colonization

Interventions

ProbioticDIETARY_SUPPLEMENT

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.

placeboDIETARY_SUPPLEMENT

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

International Islamic University Malaysia

Kuala Lumpur, Selangor, Malaysia

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

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.

Time frame: 12 weeks

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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