Study of Oral Heat-killed Lactobacillus johnsonii TCI250 or White Pomegranate Extract to Improve Vaginal Flora and Health in Women Aged 20 to 45

What this Trial Is About

Researchers are evaluating the effects of Lactobacillus johnsonii TCI250 probiotics and white pomegranate extract on female vaginal bacteria and inflammation. This trial aims to understand how these supplements may regulate vaginal flora and improve vaginal health in women aged 20 to 45 with certain vaginal bacterial conditions. The study is randomized, double-blind, and includes 150 female participants. Participants will be randomly assigned to one of three groups a placebo group, a group receiving heat-killed Lactobacillus johnsonii TCI250, or a group receiving 500 mg of white pomegranate extract. The intervention lasts 8 weeks, followed by an 8-week observation period. During the study, participants provide information on their diet, lifestyle, and health and undergo biological sample collection for analysis. Throughout the 16-week study, participants will have vaginal epithelial cell samples and blood collected at weeks 0, 8, and 16 to monitor vaginal microbiota changes, inflammation markers, and liver and kidney function. Researchers will assess the vaginal bacterial status using Nugent scores and inflammatory markers like IL-4, IL-10, IL-6, IL-8, MCP-1, TNF-, and IL-1. Data analysis includes statistical comparisons among groups and over time to evaluate the impact of the supplements on vaginal health.

Effect of Lactobacillus Johnsonii or White Pomegranate Extract on the Vaginal Health