Microbial ColonizationPhase 2/3NCT05302687
Probiotic Modulates Vaginal Microflora
A Phase 2/3 study testing Probiotic in people with Microbial Colonization, run by Min-Tze LIONG at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Jan 2022to 18 Mar 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
International Islamic University Malaysia
Kuala Lumpur, Selangor, 50728
About this study
Official title: 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.
Read the 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.
- Conditions
- Microbial Colonization
- Being tested
- Probiotic, placebo
- Keywords
- probiotics
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary 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.
placeboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Jan 2022
- Primary completion18 Mar 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Min-Tze LIONG
- Sponsor type
- University, hospital or other
- Collaborators
- International Islamic University Malaysia
- Responsible party
- Sponsor-investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Syahril Azizan Azha, Doctor, Principal investigator, IIUM Kuantan Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302687
- Sponsor's protocol ID
- IREC 2021-318
- Status last verified
- Jun 2024
- First submitted
- 17 Mar 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nisaa AA, Goh KS, Mageswary U, Kadir MN, Sany S, Ismail EHE, Liong MT, Tan JS, Azizan AS. Randomized, Double-Blind, Placebo-Controlled Trial of the Probiotic Lactiplantibacillus plantarum Probio87 for Gut-Vaginal Microbiota Modulation in Healthy Women. Mol Nutr Food Res. 2026 Jul;70(13):e70535. doi: 10.1002/mnfr.70535.
PubMed 42441416Nisaa 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.
PubMed 40008414
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Probiotic to Modulate Vaginal Microflora and General Women's Health
- ClinicalTrials.gov ID
- NCT05302687
- Acronym / sponsor ID
- IREC 2021-318
- Conditions
- Microbial Colonization
- Keywords
- probiotics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Min-Tze LIONGUniversity, hospital or other
- Collaborators
- International Islamic University Malaysia
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| probiotic 9 log CFU/day | Experimental | Dietary Supplement: ProbioticIntervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic. |
| placebo | Placebo comparator | Dietary Supplement: placeboplacebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as light-yellow powder. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticThis 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. | Dietary supplement | probiotic 9 log CFU/day |
| placeboThis 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. | Dietary supplement | placebo |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Derived from this study: PubMed 42441416Nisaa AA, Goh KS, Mageswary U, Kadir MN, Sany S, Ismail EHE, Liong MT, Tan JS, Azizan AS. Randomized, Double-Blind, Placebo-Controlled Trial of the Probiotic Lactiplantibacillus plantarum Probio87 for Gut-Vaginal Microbiota Modulation in Healthy Women. Mol Nutr Food Res. 2026 Jul;70(13):e70535. doi: 10.1002/mnfr.70535.
- Derived from this study: PubMed 40008414Nisaa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syahril Azizan Azha, Doctor principal investigator
IIUM Kuantan Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Probiotic in people with Microbial Colonization, run by Min-Tze LIONG at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in general women's health (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05302687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.