Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative

Randomized, Double-blind, Placebo-controlled Study ,Oral U-relax in the Influence of the Vaginal Environment Health Promotion, and the HPV DNA Test Index Change From Positive to Negative on the HPV Infection Women

The purpose of this study is to understand the effect of using oral U-relax on HPV infected women for vaginal environment health promotion, and the HPV DNA Test Index change from positive to negative. Long-term infection of HPV is associated with cervical cancer. U-relax contains Lactobacillus GR-1 and Lactobacillus RC-14 and has been approved of its benefits on treatment of BV, UTI, IBD and can improve vaginal environment health. Patients with positive result of HPV DNA test have no appropriate and aggressive treatment to reduce the risk of cervical cancer. This clinical trial tries to reveal the influence of oral U-relax and patients with HPV DNA test positive result.

This study is a prospective, double blind, randomized clinical trial. Vaginal health screening and HPV DNA Test are carried out from 80 patients with positive HPV DNA Test after conization for 6 months. All these patients will participant this study during the 360-day trial period. All health related conditions will be monitored at the same time.

U-relax Group: U-relax capsules Day 1-5: take two capsuals of oral U-relax everyday before sleep Day 6-360: take one capsule of oral U-relax everyday before sleep Control Group: Placebo capsules Day 1-5: take two capsuals of oral placebo everyday before sleep Day 6-360: take one capsual of oral placebo everyday before sleep

same capsule appearance and bottle without any marks for identification to participants, care providers and investigators except serial numbers

Day 1-5: take two capsuals of oral U-relax everyday before sleep Day 6-360: take one capsual of oral U-relax everyday before sleep

Day 1-5: take two capsuals of oral placebo everyday before sleep Day 6-360: take one capsual of oral placebo everyday before sleep

Inclusion Criteria: female age over 30 PAP Test with NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY result HPV DNA Index Test with POSITIVE result after conization for 6 months not pregnant Exclusion Criteria: cervical intraepithelial neoplasia before conization cervical cancer patient with GI surgery GI dysfunction need for long-term antibiotics treatment

Ou YC, Fu HC, Tseng CW, Wu CH, Tsai CC, Lin H. The influence of probiotics on genital high-risk human papilloma virus clearance and quality of cervical smear: a randomized placebo-controlled trial. BMC Womens Health. 2019 Jul 24;19(1):103. doi: 10.1186/s12905-019-0798-y.