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

Not Applicable

Recruiting

• Conditions: Human papilloma virus infection; Human papilloma virus, Anal intraepithelial neoplasia; D052685

• Registration Number: JPRN-jRCTs031220710
• Lead Sponsor: Mizushima Daisuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified