Probiotic Modulates Vaginal Microflora

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05302687
• Other study ID #: IREC 2021-318
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 15, 2022
• Est. completion date: March 18, 2024

Study information

• Verified date: June 2024
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 18, 2024
• Est. primary completion date: March 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Dietary Supplement:
• Probiotic
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.
• placebo
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.

Locations

Country	Name	City	State
Malaysia	International Islamic University Malaysia	Kuala Lumpur	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Min-Tze LIONG	International Islamic University Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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