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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic 9 log CFU/day | Experimental | Intervention consists of daily oral administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic. |
|
| placebo | Placebo Comparator | placebo 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotic | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MingTze Liong, Doctor | School of Industrial Technology USM | Study Director |
| Binti Sany Salina, Doctor | Institut Perubatan & Pergigian Termaju USM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Seberang Jaya | Pulau Pinang | Pulau Pinang | 13700 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40884128 | Derived | 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. | |
| 40495681 |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| placebo | Other | oral administration of primarily carrier without the probiotic for 12 weeks |
|
| 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. |
| 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. |
| 40360161 | Derived | 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. |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |