Clinical trial NCT05316064: Reducing Abundance of Human Papilloma Virus in Women by Taking Probiotic
Official title: The Effects of Probiotic Against Reducing Abundance of Human Papilloma Virus (HPV) in Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Human Papilloma Virus Infection
Keywords: probiotics
human papilloma virus
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in vaginal abundance of HPV of women upon administration of probiotic.
timeFrame: 12-weeks
Secondary outcomes:
measure: Changes in vaginal microbiota of women upon administration of probiotic.
timeFrame: 12-weeks
measure: Changes in gut microbiota of women upon administration of probiotic.
timeFrame: 12-weeks
measure: Changes in vaginal health of women upon administration of probiotic via the use of questionnaire.
timeFrame: 12-weeks
measure: Changes in immunity of women upon administration of probiotic 9 log CFU/day as assessed via biochemical tests.
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Pulau pinang
country: Malaysia
facility: Hospital Seberang Jaya
state: Penang
Study officials:
affiliation: School of Industrial Technology USM
name: MingTze Liong, Doctor
role: STUDY_DIRECTOR
affiliation: Institut Perubatan & Pergigian Termaju USM
name: Binti Sany Salina, Doctor
role: PRINCIPAL_INVESTIGATOR
References: