Probiotic Modulates Vaginal Microflora

Study Overview
=================
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.

Official Title
-----------------
Use of Probiotic to Modulate Vaginal Microflora and General Women's Health

Conditions
-----------------
Microbial Colonization

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic
* Dietary Supplement: placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic 9 log CFU/day<br>Intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic. | Dietary Supplement: Probiotic<br>* 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.<br>|
| Placebo Comparator: placebo<br>placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as light-yellow powder. | Dietary Supplement: placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
probiotics