Microbial Colonization
Conditions
Keywords
probiotics
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
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
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.
DIETARY_SUPPLEMENTplacebo
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.
Sponsors
International Islamic University Malaysia
Min-Tze LIONG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| differences in general women's health | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | 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. |
Countries
Malaysia
Outcome results
None listed