Status:
COMPLETED
Probiotic Modulates Vaginal Microflora
Lead Sponsor:
Min-Tze LIONG
Collaborating Sponsors:
International Islamic University Malaysia
Conditions:
Microbial Colonization
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
PHASE3
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 vagina...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2024
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05302687
Start Date
January 15 2022
End Date
March 18 2024
Last Update
June 21 2024
Active Locations (1)
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1
International Islamic University Malaysia
Kuala Lumpur, Selangor, Malaysia, 50728