Clinical Trials Logo

Clinical 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05316064
Study type Interventional
Source Universiti Sains Malaysia
Contact
Status Withdrawn
Phase Phase 2/Phase 3
Start date December 27, 2021
Completion date November 28, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04199078 - Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions. N/A
Active, not recruiting NCT02135419 - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions Phase 3
Active, not recruiting NCT02258659 - Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer Phase 2
Completed NCT02714114 - Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study) N/A
Completed NCT00303823 - Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia Phase 2
Not yet recruiting NCT05510830 - Diagnostic Cervical Conization for Persistent Infection or Integration of HPV N/A
Completed NCT04002154 - Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV N/A
Not yet recruiting NCT06123533 - Understanding Women's Values in Managing Human Papillomavirus (HPV)
Completed NCT04624568 - Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance N/A
Completed NCT05694728 - A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine Phase 2
Completed NCT04391647 - Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples
Recruiting NCT05439083 - Immunogenicity of 9-valent HPV Vaccine Phase 4
Completed NCT01446198 - Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHERâ„¢ System N/A
Completed NCT01539668 - Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas Phase 0
Recruiting NCT06467942 - Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection N/A
Completed NCT01567813 - Post-Licensure Study of the Safety of GARDASILâ„¢ in Males (V501-070)
Completed NCT02811367 - The HPV Self-test as a Test of Cure in Madagascar N/A
Completed NCT02067507 - Increasing Human Papillomavirus Vaccine Uptake in Low-Income, Ethnic Minority Adolescents in Los Angeles County N/A
Recruiting NCT01387997 - e- Ab Sensor-based Real-time Detection of Oncogenic Human Papilloma Viruses N/A
Completed NCT02634190 - Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens