Probiotic Modulates Vaginal Microflora

Sponsor

Min-Tze LIONG (Other)

Overall Status

Recruiting

CT.gov ID

NCT05302687

Collaborator

International Islamic University Malaysia (Other)

112

Enrollment

Location

Arms

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbial Colonization	Dietary Supplement: Probiotic Dietary Supplement: placebo	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A double-blind randomized placebo-controlled trial design has been chosen. Randomization for the parallel prevention phase will be carried out after checking the inclusion and exclusion criteria.A double-blind randomized placebo-controlled trial design has been chosen. Randomization for the parallel prevention phase will be carried out after checking the inclusion and exclusion criteria.

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

The randomization will be performed by the study statistician, who had no contact with the participants. The allocation sequence will not available to any member of the research team until databases had been completed and locked. Since this is a double-blinded study, both the research team and subject will not know in which group the subject is assigned to.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 15, 2022

Anticipated Primary Completion Date :

Jan 15, 2023

Anticipated Study Completion Date :

Jan 15, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Islamic University Malaysia	Kuala Lumpur	Selangor	Malaysia	50728

Sponsors and Collaborators

Min-Tze LIONG
International Islamic University Malaysia

Investigators

Principal Investigator: Syahril Azizan Azha, Doctor, IIUM Kuantan Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Min-Tze LIONG, Professor, Universiti Sains Malaysia

ClinicalTrials.gov Identifier:

NCT05302687

Other Study ID Numbers:

IREC 2021-318

First Posted:

Mar 31, 2022

Last Update Posted:

Apr 12, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Min-Tze LIONG, Professor, Universiti Sains Malaysia

probiotics

Additional relevant MeSH terms:

Communicable Diseases

Infections

Study Results

No Results Posted as of Apr 12, 2022