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Completed

NCT Number: NCT05302687

Probiotic Modulates Vaginal Microflora

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.

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

International Islamic University Malaysia

Kuala Lumpur, Selangor, 50728, Malaysia

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. differences in general women's health

    Time frame: 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.

  2. differences in immunity of women

    Time frame: 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.

  3. differences in gut microbiota profiles of women

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Min-Tze LIONG

Other

Collaborators

  • International Islamic University Malaysia

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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