Probiotic Modulates Vaginal Microflora

NCT05302687 | Completed Phase 2

• 1 other identifier: IREC 2021-318
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Colonization

Keywords

probiotics

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

probiotic 9 log CFU/day

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as light-yellow powder.

Dietary Supplement: placebo

Interventions

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.

probiotic 9 log CFU/day

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.

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Min-Tze LIONG: lead
• International Islamic University Malaysia: collaborator

Study Sites (1)

International Islamic University Malaysia

Kuala Lumpur, Selangor, 50728, Malaysia

Location

Related Publications (1)

• Nisaa AA, Mageswary U, Pei X, Kadir MN, Oon CE, Rajendran D, Tan JJ, Roslan FF, Balasubramaniam SD, Sany S, Ismail EHE, Azizan AS, Liong MT. Probiotic enhanced immunity and mental wellbeing of generally healthy women: a randomised, placebo-controlled and double-blind study. Benef Microbes. 2025 Feb 24;16(4):377-394. doi: 10.1163/18762891-bja00061.

  PMID: 40008414 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Syahril Azizan Azha, Doctor

  IIUM Kuantan Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 31, 2022
• Study Start: January 15, 2022
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)