Probiotic Modulates Vaginal Microflora

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

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.

Study Overview

• Status: Completed
• Conditions: Microbial Colonization
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Kuala Lumpur, Selangor, Malaysia, 50728
      • International Islamic University Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: probiotic 9 log CFU/day; Intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.	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 Comparator: placebo; placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as light-yellow powder.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Min-Tze LIONG
• Collaborators: International Islamic University Malaysia
• Investigators: Principal Investigator: Syahril Azizan Azha, Doctor, IIUM Kuantan Campus

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): March 18, 2024
• Study Completion (Actual): March 18, 2024

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 26, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: probiotics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: IREC 2021-318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No