Efficacy of Lactococcus lactis strain Plasma on clearance of anal HPV infection in men who have sex with men; multi-center, double-blinded, randomized placebo-controlled trial

Efficacy of Lactococcus lactis strain Plasma on clearance of anal HPV infection in men who have sex with men; multi-center, double-blinded, randomized placebo-controlled trial - CLEAR HPV study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031220710

Enrollment

150

Registered

2023-03-17

Start date

2023-05-23

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Human papilloma virus infection Human papilloma virus, Anal intraepithelial neoplasia

Interventions

After obtaining their consent, the study subjects are randomly assigned into the following two groups

- Group A: orally intake Lactococcus lactis strain Plasma-containing capsules (4 capsules/time, once daily, after breakfast in principal) for 180 days - Group B: orally intake placebo-containing capsu

D013294

Lactococcus lactis strain Plasma

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Subjects who meet all of the following criteria are included in this study: 1. Subjects who have anal high-risk human papilloma virus infection 2. Men who have sex with men who are aged of 20 years or older and younger than 65 years 3. Subjects who give their written consent form to participate in the study

Exclusion criteria

Exclusion criteria: Subjects who fall into any of the following criteria are excluded from participating in the study: 1. HIV-infected patients who are not taking anti-retroviral therapy 2. Subjects who are being treated by immunosuppressive agents or corticosteroids at giving their consent 3. Subjects who are administered intestinal regulators orally 4. Subjects who are taking one or more beverage or foods that contain Lactococcus lactis strain Plasma or yogurt (that contain lactic acid bacteria or Lactobacillus bulgaricus) everyday 5. Subjects with other conditions that the responsible investigator or subinvestigators assess inappropriate to participate in the study

Design outcomes

Primary

Measure	Time frame
Change in high-risk HPV genotype infected at anal site and its clearance at 180 days	—

Secondary

Measure	Time frame
1. Change or percent change in high-risk HPV genotype infected at anal site at 180 days 2. Change in anal epithelial neoplasia by high resolution anoscopy at 180 days. 3. Change in abnormal cytology by anal pap smear at 180 days. 4. Change or percent change in the number of peripheral blood CD4 positive T-lymphocyte in HIV-infected participants at 180 days. 5. Change or percent change in serum HBs antigen and HBe antigen in chronic HBV-infected participants at 180 days. 6. Adherence rate. 7. Any adverse events developed during the observational period.	—

Measure

Time frame

1. Change or percent change in high-risk HPV genotype infected at anal site at 180 days 2. Change in anal epithelial neoplasia by high resolution anoscopy at 180 days. 3. Change in abnormal cytology by anal pap smear at 180 days. 4. Change or percent change in the number of peripheral blood CD4 positive T-lymphocyte in HIV-infected participants at 180 days. 5. Change or percent change in serum HBs antigen and HBe antigen in chronic HBV-infected participants at 180 days. 6. Adherence rate. 7. Any adverse events developed during the observational period.

—

Contacts

Public ContactDaisuke Mizushima

National Center for Global Health and Medicine

dmizushi@acc.ncgm.go.jp+81-3-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026