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Reducing Abundance of Human Papilloma Virus in Women by Taking Probiotic

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

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05316064
Enrollment
0
Registered
2022-04-07
Start date
2021-12-27
Completion date
2023-11-28
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus Infection

Keywords

probiotics, human papilloma virus

Brief 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.

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.

Interventions

BIOLOGICALprobiotic

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.

OTHERplacebo

oral administration of primarily carrier without the probiotic for 12 weeks

Sponsors

Universiti Sains Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
26 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in vaginal abundance of HPV of women upon administration of probiotic.12-weeksDifferences 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.

Secondary

MeasureTime frameDescription
Changes in vaginal microbiota of women upon administration of probiotic.12-weeksDifferences 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.
Changes in gut microbiota of women upon administration of probiotic.12-weeksDifferences 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.
Changes in vaginal health of women upon administration of probiotic via the use of questionnaire.12-weeksDifferences 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.
Changes in immunity of women upon administration of probiotic 9 log CFU/day as assessed via biochemical tests.12-weeksTo 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.

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026