Efficacy of Lactococcus lactis strain Plasma on clearance of anal HPV infection in men who have sex with men: A single-center, double-blinded, randomized placebo-controlled trial (CLEAR HPV study) Article Swipe
Daisuke Mizushima
,
Misao Takano
,
Naokatsu Ando
,
Hiroshi Kitamura
,
Daisuke Shiojiri
,
Takato Nakamoto
,
Takahiro Aoki
,
Koji Watanabe
,
Yosuke Shimizu
,
Yukari Uemura
,
Hiroyuki Gatanaga
,
Shinichi Oka
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1097/md9.0000000000000300
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1097/md9.0000000000000300
Background: Anal cancer is a human papillomavirus-related cancer; specifically, it is preceded by high-grade squamous intraepithelial lesions, which are less likely to regress spontaneously than low-grade intraepithelial lesions. Although most human papillomavirus (HPV) infections are thought to clear spontaneously, anal HPV infection persists, especially in people living with HIV. Preliminary results from a recent small randomized placebo-controlled trial of oral bacteriotherapy using a high dose of probiotics demonstrated clearance of anal high-risk HPV (hr-HPV) infection and lower onset of new high-grade squamous intraepithelial lesions among people living with HIV. Lactococcus lactis strain Plasma is a lactic acid bacterium directly activating plasmacytoid dendritic cells and inducing release of type I and III interferons via Toll-like receptor 9 stimulation. Based on these findings, oral bacteriotherapy with LC-plasma may contribute to clearing anal hr-HPV infection and reducing anal precancerous lesions by activating innate and acquired immune responses. This randomized placebo-controlled trial aims to investigate the efficacy and safety of LC-plasma therapy in clearing anal hr-HPV infection and reducing anal precancerous lesions among men who have sex with men with or without HIV infection. Methods: Participants with anal hr-HPV infection will be included and receive test capsules. A total of 150 patients will be included in the intervention group with follow-up, which will consist of HPV genotype test, cytology by anal pap smear, and biopsy with high-resolution anoscopy. The primary endpoint will be the clearance rate of the hr-HPV genotype infection at the anal site at 180 days. The secondary endpoints will be changes in anal epithelial neoplasia detected using high-resolution anoscopy at 180 days; change in abnormal cytology by anal pap smear at 180 days; change in hr-HPV genotype at the anal site at 180 days; change or percentage change in peripheral blood CD4 positive T-lymphocyte numbers in HIV-infected participants at 180 days; changes in quantitative hepatitis B surface antigen levels at 180 days in the HBV-infected participants; and adherence to the study drugs. Conclusion: This randomized controlled study will provide data on the efficacy and safety of LC-plasma as a treatment for anal HPV infection and grade 2 or 3 anal intraepithelial neoplasia.
Related Topics
Concepts
Medicine
Anal cancer
HPV infection
Randomized controlled trial
Internal medicine
Men who have sex with men
Clinical endpoint
Gastroenterology
Placebo
Gynecology
Cancer
Immunology
Cervical cancer
Pathology
Human immunodeficiency virus (HIV)
Syphilis
Alternative medicine
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1097/md9.0000000000000300
- OA Status
- hybrid
- References
- 19
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4387747193
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4387747193Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1097/md9.0000000000000300Digital Object Identifier
- Title
-
Efficacy of Lactococcus lactis strain Plasma on clearance of anal HPV infection in men who have sex with men: A single-center, double-blinded, randomized placebo-controlled trial (CLEAR HPV study)Work title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2023Year of publication
- Publication date
-
2023-10-01Full publication date if available
- Authors
-
Daisuke Mizushima, Misao Takano, Naokatsu Ando, Hiroshi Kitamura, Daisuke Shiojiri, Takato Nakamoto, Takahiro Aoki, Koji Watanabe, Yosuke Shimizu, Yukari Uemura, Hiroyuki Gatanaga, Shinichi OkaList of authors in order
- Landing page
-
https://doi.org/10.1097/md9.0000000000000300Publisher landing page
- Open access
-
YesWhether a free full text is available
- OA status
-
hybridOpen access status per OpenAlex
- OA URL
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https://doi.org/10.1097/md9.0000000000000300Direct OA link when available
- Concepts
-
Medicine, Anal cancer, HPV infection, Randomized controlled trial, Internal medicine, Men who have sex with men, Clinical endpoint, Gastroenterology, Placebo, Gynecology, Cancer, Immunology, Cervical cancer, Pathology, Human immunodeficiency virus (HIV), Syphilis, Alternative medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- References (count)
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19Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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