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AzTrials

Human Papilloma Virus InfectionPhase 2/3NCT05316064

Reducing Abundance of Human Papilloma Virus in Women by Taking Probiotic

A Phase 2/3 study testing probiotic in people with Human Papilloma Virus Infection, run by Universiti Sains Malaysia at 1 site in Malaysia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of oral administration of probiotic at 9 log colony forming unit (CFU)/day to reduce vaginal abundance of HPV in women compared to placebo via the use of vaginal self-swab. Read more about this study

Who is it for?
Ages 26 years and older, women only
Conditions the study is for
Human Papilloma Virus Infection
What is being tested?
probiotic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteMalaysia
Study dates
27 Dec 2021to 28 Nov 2023
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 26 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sexually active women
  • Age above 26 years old
  • Determined as HPV positive against L1 variant
  • Willing to commit throughout the experiment

Who cannot join

  • On long term medication (6 months and above) for any illnesses
  • Pregnant
  • Uterus and/or cervix removed
  • Prior HPV vaccination
  • Cervical intraepithelial neoplasia

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Hospital Seberang Jaya

    Pulau Pinang, Pulau Pinang, 13700

Other trials in Malaysia

About this study

Official title: The Effects of Probiotic Against Reducing Abundance of Human Papilloma Virus (HPV) in Women

The purpose of this study is to evaluate the efficacy of oral administration of probiotic at 9 log colony forming unit (CFU)/day to reduce vaginal abundance of HPV in women compared to placebo via the use of vaginal self-swab.

Read the detailed description

Probiotics have shown an antiviral activity and several mechanisms have been demonstrated. In respiratory tract infections (RTIs), the majority of probiotics can inhibit the most important respiratory viruses by immunomodulatory mechanisms. There are over 200 different types of viruses, which cause RTIs in humans. Human rhinoviruses (HRV) are the largest group of respiratory viruses, comprising over 150 serotypes. In humans, the predominant illness caused by HRV is the acute upper RTI, also known as the common cold. The second most common viruses infecting humans are the human enteroviruses (HEV), which are associated with clinical manifestations ranging from mild respiratory symptoms to serious conditions. Influenza viruses, respiratory syncytial virus (RSV), and adenoviruses are also major causative agents of both upper and lower RTIs. In addition, many other viruses or virus groups cause RTIs, e.g., parainfluenza viruses and coronaviruses can cause a broad spectrum of respiratory diseases, ranging from mild upper RTIs to pneumonia. In recent years, with the rapid development of high-throughput molecular techniques, several new viruses associated with respiratory diseases, such as human bocavirus, human metapneumovirus, and the new coronaviruses HKU1 and NL63, have been identified as well. Recently, COVID-19 had cause huge effect worldwide. With this, to reduce the burden and severity of this pandemic, the use of probiotic in preventing of COVID-19 has been ongoing. Probiotics also had given out significant outcome in gastroenteritis infections where a study suggested that probiotics had be effective in alleviating the duration and severity of acute rotavirus gastroenteritis. Apart from this, for viruses that cause hepatitis, skin virus infections, human immunodeficiency virus (HIV), or HPV, probiotics could directly or indirectly, help reduce their symptoms or prevent infection.

Probiotics are known as a good natural non-drug, which was widely used to boost immune cells in host to fight against infection. Generally, probiotic effects are mediated through immune regulation, particularly through balance control of proinflammatory and anti-inflammatory cytokines. The immune response is initiated by innate immunity following exposure to foreign substances or tissue injury. Innate immunity exerts protective roles in host homeostasis in part by priming adaptive immune responses against persisting insults and inducing inflammation. However, the unbalanced immune response leads to severe inflammation and uncontrolled tissue damage and disease. Probiotics have been found to enhance the innate immunity and modulate pathogen-induced inflammation via toll-like receptor-regulated signaling pathways.

Being tested
probiotic, placebo
Keywords
probiotics, human papilloma virus
Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • probioticBiological

    oral administration of probiotic at 9 log CFU/day for 12 weeks to reduce vaginal abundance of HPV in women compared to placebo via the use of vaginal self-swab.

  • placeboOther

    oral administration of primarily carrier without the probiotic for 12 weeks

Study groups in NCT05316064
Study groupRoleWhat they receive
probiotic 9 log CFU/dayExperimentalIntervention consists of daily oral administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.
Receives: Biological: probiotic
placeboPlacebo comparatorplacebo contains primarily carrier without probiotic and it is identical in taste and appearance and appear as light-yellow powder. It is also taken by the participants for 12 weeks.
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in vaginal abundance of HPV of women upon administration of probiotic.

    Differences in vaginal HPV abundance in women upon administration of probiotic at 9 log CFU/day compared to placebo via real-time PCR quantification of the L1 capsid gene as a conserved region of the HPV genome using consensus primers PGMY09 and PGMY1.

    Measured: 12-weeks

Secondary outcomes (4)

  1. Changes in vaginal microbiota of women upon administration of probiotic.

    Differences in vaginal microbiota in women upon administration of probiotic at 9 log CFU/day compared to placebo via microbiota profiling using DNA of vaginal samples amplified for bacterial 16S rRNA and analyzed for high-throughput community sequencing.

    Measured: 12-weeks

  2. Changes in gut microbiota of women upon administration of probiotic.

    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

  3. Changes in vaginal health of women upon administration of probiotic via the use of questionnaire.

    Differences in total scores of women upon administration of probiotic at 9 log CFU/day compared to placebo via the use of vulvovaginal symptom questionnaire (VSQ) containing 21-items on a two-point scale with higher scores indicating poorer health status.

    Measured: 12-weeks

  4. Changes in immunity of women upon administration of probiotic 9 log CFU/day as assessed via biochemical tests.

    To evaluate differences in immunity of women on probiotic and placebo in terms of blood immunity profiling via measuring concentrations of immunoglobulins such as IgA, IgG and IgM, and cytokines such as interleukin (IL)-1b, IL-4, IL-10, TNF-α and IFN-γ using commercially available ELISA kits.

    Measured: 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start27 Dec 2021
  3. Primary completion28 Nov 2023 (estimated)
  4. Study completion28 Nov 2023 (estimated)

Why it stopped: funding problem

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05316064
Sponsor's protocol ID
NMRR-21-1819-61300 (IIR)
Status last verified
May 2024
First submitted
17 Mar 2022
Last updated
10 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu P, Mageswary MU, Nisaa AA, Samsudin SB, Rusdi NIBM, Jerip ARA, Oon CE, Sany SB, Tan CS, Zhu ZH, Liong MT. Probiotic Lactiplantibacillus plantarum Probio87 Improves Gut Microbial Profiles in HPV-Positive Women: A Randomized, Placebo-Controlled and Double-Blind Study. Mol Nutr Food Res. 2025 Nov;69(22):e70247. doi: 10.1002/mnfr.70247. Epub 2025 Aug 30.

    PubMed 40884128

  • Xu P, Uma Mageswary M, Nisaa AA, Balasubramaniam SD, Samsudin SB, Rusdi NIBM, Jerip ARA, Oon CE, Bakar MHA, Tan JJ, Roslan FF, Kadir MN, Ismail EHBE, Sany SB, Tan CS, Liong MT. Impact of the Probiotic on the Modulation of Vaginal Bacterial and Fungal Microbiota in HPV-Positive Women. Mol Nutr Food Res. 2025 Sep;69(18):e70142. doi: 10.1002/mnfr.70142. Epub 2025 Jun 11.

    PubMed 40495681

  • Xu P, Mageswary U, Nisaa AA, Balasubramaniam SD, Samsudin SB, Rusdi NIBM, Jerip ARA, Oon CE, Bakar MHA, Rajendran D, Tan JJ, Roslan FF, Sreenivasan S, Balakrishnan V, Sany SB, Tan CS, Liong MT. Probiotic reduces vaginal HPV abundance, improves immunity and quality of life in HPV-positive women: a randomised, placebo-controlled and double-blind study. Benef Microbes. 2025 May 12;16(6):667-684. doi: 10.1163/18762891-bja00079.

    PubMed 40360161

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing probiotic in people with Human Papilloma Virus Infection, run by Universiti Sains Malaysia 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 10 May 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 was withdrawn before enrolling participants, so there are no results.

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?

Changes in vaginal abundance of HPV of women upon administration of probiotic. (time frame: 12-weeks). 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 NCT05316064, which also lists 3 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 10 May 2024.

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