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

JRCT ID: jRCTs031220710

Registered date:17/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Human papilloma virus infection
• Date of first enrollment: 23/05/2023
• Target sample size: 150
• Study type: Interventional
• Intervention(s): 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 capsules (4 capsules/time, once daily, after breakfast in principal) for 18 days

Outcome(s)

• Primary Outcome: Change in high-risk HPV genotype infected at anal site and its clearance at 180 days
• Secondary Outcome: 1. Change in anal epithelial neoplasia by high resolution anoscopy at 180 days. 2. Change in abnormal cytology by anal pap smear at 180 days. 3. Change or percent change in the number of peripheral blood CD4 positive T-lymphocyte in HIV-infected participants at 180 days.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Male
• Include 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
• Exclude 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

Related Information

• Primary Sponsor: Mizushima Daisuke
• Secondary Sponsor: Oka Shinichi