Probiotic Modulates Vaginal Microflora

Phase 2

Completed

• Conditions: Microbial Colonization
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Probiotic

• Registration Number: NCT05302687
• Lead Sponsor: Min-Tze LIONG

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.

Study Timeline

• Study Start: 2022-01-15
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-26
• Study First Posted: 2022-03-31
• Primary Completion: 2024-03-18
• Study Completion: 2024-03-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as light-yellow powder.
probiotic 9 log CFU/day	Probiotic	Intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

International Islamic University Malaysia; 🇲🇾 Kuala Lumpur, Selangor, Malaysia